Podcasts about ldts

Medboard EU EU MDR and IVDR article 10a - Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a EU IVDR transition periods - Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdfEUDAMED EMDN: UPDATE or not to UPDATE - MDCG 2024-2 Rev 1 and 2021-12 Rev 1 : https://health.ec.europa.eu/document/download/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pdf MDCG 2024-2: https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf MDCG 2021-12: https://health.ec.europa.eu/document/download/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en?filename=md_2021-12_en.pdf Contact points of National Authorities - Bookmark them in case: https://health.ec.europa.eu/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf EU Battery 2023/1542 - Guidance issued by EU commission: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202500214 Swiss Maintenance of Medical Devices - Guidance for Hospitals: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing---maintenance/maintenance.html UK timeline for UKCA - Be ready for 2030: https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf UK Post-Market Surveillance - Implementation and Template of PSUR: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation https://assets.publishing.service.gov.uk/media/67813b39363ac763c8ede498/Medical_devices_periodic_safety_update_report__PSUR__formatting__1_.pdf PMS Guidance: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-periodic-safety-update-reports PMS Requirements: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes PMS Obligations per device type: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-pms-obligations-by-medical-device-type   TUK Vigilance Reporting - Field Safety notices and Example of incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents FSN: https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices#full-publication-update-history Devices for cardiac ablation: https://www.gov.uk/government/publications/reporting-adverse-incidents-devices-for-cardiac-ablation Joint Replacement implant: https://www.gov.uk/government/publications/reporting-adverse-incidents-joint-replacement-implants#full-publication-update-history Intraocular lenses: https://www.gov.uk/government/publications/reporting-adverse-incidents-intraocular-lenses Insulin pumps and meter systems: https://www.gov.uk/government/publications/reporting-adverse-incidents-insulin-pumps-and-meter-systems   UK guide for IVD - Learn before to re-learn: https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf Training EU MDR training - Green Belt Certification Program: https://school.easymedicaldevice.com/course/gb33/ Rest of the World: Laboaratory Developed Tests FAQ - Learn all about LDTs: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs and https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/medical-device-reporting-complaints-and-corrections-removals-reporting-laboratory-developed-tests How to apply your dossier in Australia - Full guidance by TGA: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/australian-regulatory-evidence-options-medical-device-application/tga-conformity-assessment-certification/application-instructions-conformity-assessment Malaysia guidance for HIV Self-test - Placement on the Malaysia Market: https://www.mda.gov.my/index.php/documents/ukk/3480-final-gd-placement-of-hiv-self-test-kit-in-malaysia-market-2nd-edition-pdf/file Import Medical Device for Personnal Use in Malaysia - What means Personal use? https://portal.mda.gov.my/index.php/documents/ukk/3468-draft-public-comment-gd-importation-of-medical-device-for-personal-use-second-edition-updated-2025-pdf/file Alert by Philippines for Product registration - Engaging consultants is not encouraged: https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0033-.pdf Saudi Arabia clearance of Medical Devices - For trainings or conferences: https://www.sfda.gov.sa/sites/default/files/2025-01/Guide%20to%20Conditions%20and%20requirements%20for%20Clearing%20food%2C%20Medical%20devices%2C%20and%20cosmetics%20for%20exhibitions%2C_1.pdf China Medical Device Regulations Round-up 2024 - Cisema.com video: 2024 Round-Up of China Medical Device regulations India update classification lists - List available: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNDI= Podcast Episode 318 - How to register a Medical Device in South Africa - Khanysile Nkuku : https://podcast.easymedicaldevice.com/318-2/ Episode 319 - How to perform your PMS for a Drug-Device Combination - Joan D'Souza: https://podcast.easymedicaldevice.com/319-2/ Episode 320 - Top 5 common NCs on an ISO 13485 audit: https://podcast.easymedicaldevice.com/320-2/ Episode 321 - 6 Tips to grow as a QA RA Manager: https://podcast.easymedicaldevice.com/321-2/

Be sure to tune in to this episode of the Precision Health and PGX Podcast as Dr. Becky Winslow, Dr. Behnaz Sarrami, and Dr. Jeremy Stuart, Chief Scientific Officer and laboratory director for Precision Genetics, discuss pharmacists value as employees in clinical pharmacogenomics testing laboratories. Having employed pharmacists in his laboratories, Dr. Stuart will provide his first-hand examples to illustrate how pharmacists have benefited his laboratories. Dr. Winslow and Dr. Sarrami will also share their real-world experiences working for clinical pharmacogenomics laboratories to help the laboratory achieve its goals. This episode is a must listen for laboratories who are vested in their pharmacogenomics testing's financial success.  After listening to this episode, the learner will be able to describe responsibilities and roles in pharmacogenomics pharmacists fulfill in clinical labs, name specific real-world examples that illustrate pharmacists' contributions to pharmacogenomics in the clinical laboratory, and name education, training, and work experiences that prepare pharmacists to assume advanced practice roles in clinical laboratories.   Dr. Jeremy Stuart has extensive experience in the life science industry. He specializes in commercial operations, technology development and transfer, manufacturing design, and validation of laboratory developed tests (LDTs). He currently serves as the Chief Scientific Officer for Precision Genetics and serves as their Laboratory Director.  Dr. Stuart was part of the senior management team that completed a management buyout of Lab21 Inc. to form Selah Genomics and the subsequent sale of Selah to EKF. Dr. Stuart led the development and validation of all of Selah's molecular assays and oversaw their clinical studies. Dr. Stuart was also a member of the Agencourt Personal Genomics team, where he co-developed the SOLiD next-generation sequencing technology that was subsequently acquired by Applied Biosystems.   Before entering industry, Dr. Stuart completed his postdoctoral work at the the Harvard School of Public Health, earned his master's degree in Toxicology from the University of Minnesota, and his doctorate in Genetics & Complex Diseases from Harvard University.  As the CEO of inGENEious RX Incorporated and pharmacogenomics subject matter expert, Dr. Becky Winslow has dedicated over a decade to providing innovative solutions for pharmacogenomics stakeholders. Her extensive experience also includes directing pharmacy operations and medication safety programs across diverse clinical settings, spanning retail, hospital, long-term care, and public health. Dr. Winslow is a passionate educator, training Doctors of Clinical Pharmacy to work with molecular testing stakeholders and serving as an advanced pharmacy practice preceptor for Manchester University's Master of Science in Pharmacogenomics Program. She hosts an evidence-based educational podcast, The Precision Health and PGx Podcast, which Welp Magazine recognized as the ninth most listened to genetics podcast globally. Her involvement with prominent organizations like the Clinical Pharmacogenetics Implementation Consortium and the National Council for Prescription Drug Programs (NCPDP) PGx Task Force speaks to her expertise and commitment. Dr. Winslow frequently presents at national conferences such as The Association for Molecular Pathology and holds degrees from Campbell University.  Behnaz Sarrami, PharmD, MS, is a leading expert in pharmacogenomics and a dedicated Medical Science Liaison (MSL). She is named American Pharmacists Association's (APhA) "50 Most Influential Leaders in Pharmacy" and Medika's "Top 30 Women Transforming Healthcare". Behnaz is passionate about advancing personalized medicine to optimize treatments and improve patient outcomes, especially in underserved populations. She supports healthcare professionals through scientific training and presentations. As the host of the "Precision Health and PGx" podcast, she mentors pharmacists transitioning into MSL roles and those launching pharmacogenomics consulting careers. She earned her Master's in Biochemistry from Georgetown University and her Doctorate in Pharmacy from Creighton University. With significant contributions to research and education, she continues to drive innovation in pharmacogenomics through her work with healthcare professionals and community outreach programs.

Be sure to tune in to this episode of the Precision Health and PGX Podcast as Dr. Becky Winslow, Dr. Behnaz Sarrami, and Dr. Jeremy Stuart, Chief Scientific Officer and laboratory director for Precision Genetics, discuss pharmacists value as employees in clinical pharmacogenomics testing laboratories. Having employed pharmacists in his laboratories, Dr. Stuart will provide his first-hand examples to illustrate how pharmacists have benefited his laboratories. Dr. Winslow and Dr. Sarrami will also share their real-world experiences working for clinical pharmacogenomics laboratories to help the laboratory achieve its goals. This episode is a must listen for laboratories who are vested in their pharmacogenomics testing's financial success.  After listening to this episode, the learner will be able to describe responsibilities and roles in pharmacogenomics pharmacists fulfill in clinical labs, name specific real-world examples that illustrate pharmacists' contributions to pharmacogenomics in the clinical laboratory, and name education, training, and work experiences that prepare pharmacists to assume advanced practice roles in clinical laboratories.   Dr. Jeremy Stuart has extensive experience in the life science industry. He specializes in commercial operations, technology development and transfer, manufacturing design, and validation of laboratory developed tests (LDTs). He currently serves as the Chief Scientific Officer for Precision Genetics and serves as their Laboratory Director.  Dr. Stuart was part of the senior management team that completed a management buyout of Lab21 Inc. to form Selah Genomics and the subsequent sale of Selah to EKF. Dr. Stuart led the development and validation of all of Selah's molecular assays and oversaw their clinical studies. Dr. Stuart was also a member of the Agencourt Personal Genomics team, where he co-developed the SOLiD next-generation sequencing technology that was subsequently acquired by Applied Biosystems.   Before entering industry, Dr. Stuart completed his postdoctoral work at the the Harvard School of Public Health, earned his master's degree in Toxicology from the University of Minnesota, and his doctorate in Genetics & Complex Diseases from Harvard University.  As the CEO of inGENEious RX Incorporated and pharmacogenomics subject matter expert, Dr. Becky Winslow has dedicated over a decade to providing innovative solutions for pharmacogenomics stakeholders. Her extensive experience also includes directing pharmacy operations and medication safety programs across diverse clinical settings, spanning retail, hospital, long-term care, and public health. Dr. Winslow is a passionate educator, training Doctors of Clinical Pharmacy to work with molecular testing stakeholders and serving as an advanced pharmacy practice preceptor for Manchester University's Master of Science in Pharmacogenomics Program. She hosts an evidence-based educational podcast, The Precision Health and PGx Podcast, which Welp Magazine recognized as the ninth most listened to genetics podcast globally. Her involvement with prominent organizations like the Clinical Pharmacogenetics Implementation Consortium and the National Council for Prescription Drug Programs (NCPDP) PGx Task Force speaks to her expertise and commitment. Dr. Winslow frequently presents at national conferences such as The Association for Molecular Pathology and holds degrees from Campbell University.  Behnaz Sarrami, PharmD, MS, is a leading expert in pharmacogenomics and a dedicated Medical Science Liaison (MSL). She is named American Pharmacists Association's (APhA) "50 Most Influential Leaders in Pharmacy" and Medika's "Top 30 Women Transforming Healthcare". Behnaz is passionate about advancing personalized medicine to optimize treatments and improve patient outcomes, especially in underserved populations. She supports healthcare professionals through scientific training and presentations. As the host of the "Precision Health and PGx" podcast, she mentors pharmacists transitioning into MSL roles and those launching pharmacogenomics consulting careers. She earned her Master's in Biochemistry from Georgetown University and her Doctorate in Pharmacy from Creighton University. With significant contributions to research and education, she continues to drive innovation in pharmacogenomics through her work with healthcare professionals and community outreach programs.

In this episode of The Med-Tech Talent Lab, we dive into the complex world of Laboratory Developed Tests (LDTs) with Julie Ballard, a clinical laboratory expert with over 25 years of experience in operations, quality systems, and regulatory compliance. Julie shares her journey from working at Stanford Health Care to leading roles in startups like GRAIL, Genomic Health, and Guardant.We unpack the implications of the FDA's groundbreaking LDT ruling, discussing its potential impact on patient care, lab operations, and the broader industry. Julie explains the distinctions between LDTs and FDA-approved tests, the challenges labs face in adapting to the new regulations, and the critical steps they should take now to stay compliant.Julie also sheds light on how these changes create opportunities for talent in regulatory, quality, and consulting roles, offering insights into how labs can navigate this regulatory rollercoaster.Don't miss this expert analysis on one of the hottest topics in clinical labs today!Connect with Julie: https://www.linkedin.com/in/julieballardcarrotclinical/Learn more about Carrot Clinical: https://www.carrotclinical.com/

Send us a textWhat does the FDA jurisdiction for LDTs mean for the labs? Do they need to worry? How do they need to change the way they operate?In this episode, I talk with Dr. Thomas Nifong, a clinical pathologist and VP of CDX operations at Acrovan Therapeutics, about the recent FDA ruling on laboratory-developed tests (LDTs) issued on May 6th, 2024. We discuss the implications of considering LDTs as medical devices, requiring regulation, and explore the authority of FDA versus CLIA. The conversation also covers historical contexts, practical implications of regulatory changes, and the roles of organizations like CAP, ACLA, and AMP in legal challenges against the FDA. We dive into the differences in requirements between CLIA and FDA, New York's alternative approval route, and potential impacts on lab operations and compliance. Join us for an insightful conversation filled with essential information for those in the field of molecular pathology.00:00 Introduction and Special Guest Announcement00:24 FDA's New Rule on Laboratory Developed Tests (LDTs)01:58 Recording the Podcast: A Casual Lunch Conversation03:47 Understanding FDA's Authority Over Medical Devices08:07 Disputes and Legal Challenges12:03 Practical Implications and Industry Reactions12:47 Understanding FDA's Focus: Safety and Efficacy14:11 The Role of CMS and Medical Necessity14:48 Congressional Involvement and Legal Authority16:06 Impact on Labs and Future LDTs18:33 Quality Systems and Compliance20:16 Modifications and Software Updates21:16 Conclusion and Next StepsSupport the showBecome a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!

Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory developed tests (LDTs). What does this mean for labs going forward? On this episode, Epstein Becker Green attorneys James Boiani, Rob Wanerman, and Megan Robertson lay out the new landscape, analyze existing and potential challenges, and identify key developments to watch for as this new regulatory era unfolds. Visit our site for more information and related resources: https://www.ebglaw.com/dhc79 Subscribe for email notifications: https://www.ebglaw.com/subscribe. Visit: http://diagnosinghealthcare.com. This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.

Rachel Stauffer joins Priya Rathakrishnan to discuss significant provisions in the long-awaited Food and Drug Administration's laboratory-developed tests (LDTs) final rule.

In this special episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Division of Clinical Microbiology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the final rule issued by the U.S. Food and Drug Administration (FDA) on April 29, 2024, to make explicit its plan to regulate laboratory-developed tests (LDT) as medical devices under the Federal Food, Drug, and Cosmetic Act.Their discussion includes:Highlighting key points, exceptions, and the phased implementation plan of the final rule.How the FDA's final rule compares to its proposed rule from last year.How the news may impact laboratories, health systems, health agencies, and manufacturers.Uncertainties that still remain regarding the future of laboratory-developed tests.

In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal consultant and IVD expert at Qserve Group. With over 25 years of experience, Christie shares her extensive knowledge, discussing the nuances of IVDs, regulatory landscapes, and practical insights for professionals transitioning into or within the IVD sector.Key Timestamps:[00:00:45] - Christie Hughes's introduction and background in IVDs[00:03:30] - Discussion on the regulatory challenges and trends in 2023[00:15:22] - Differences between IVDs and other medical devices in terms of regulatory and operational frameworks[00:25:50] - Impact of regulatory changes on labs and manufacturers[00:40:10] - Detailed exploration of user needs and design controls in IVD development[00:52:00] - Advice for medical device professionals entering the IVD spaceNotable Quotes:"Understanding the user—whether a lab technician or a layperson—is critical in IVD development to ensure safety and effectiveness." - Christie HughesKey Takeaways:Trends in MedTech: The regulatory environment for IVDs is rapidly evolving, with increased scrutiny and changes in compliance requirements globally.Practical Tips: For those entering the IVD field, familiarize yourself with FDA decision summaries and EUA documentation to understand current regulatory expectations.Future Predictions: Expect continued integration of IVDs with digital health technologies, raising both opportunities and regulatory complexities.References and Resources:FDA decision summaries for recent IVD clearancesEuropean In Vitro Diagnostic Regulation (IVDR) updatesCDRH LearnFDA Proposed Rule for LDTsEpisode on LDTs with Shannon BennettChristie Hughes on LinkedInEtienne Nichols on LinkedInMedTech 101:In Vitro Diagnostic (IVD) Devices: Tools that analyze human samples (like blood or tissue) outside the body, used to diagnose diseases, conditions, or to monitor a person's overall health.Audience Interaction:Discussion Question: "How do you envision IVDs changing everyday healthcare practices in the future?"Call for Feedback:Love this episode? Leave us a review on iTunes and share your thoughts. Feedback drives our growth and allows us to improve. Reach out directly via email at podcast@greenlight.guru with your suggestions for future topics.Special Thanks to Our Sponsor:This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed...

The FDA's announcement of its intention to regulate Lab Developed Tests (LDTs) in line with medical device regulations has sparked concerns among developers, anticipating significant financial implications. We provide a comprehensive overview of seven strategic approaches for LDT developers to challenge the FDA's regulatory proposal. Firstly, leveraging the public comment period,Participating in Part 15 hearings provide direct avenues to voice concerns and influence final regulations,Additionally, joining industry associations allows for collective lobbying efforts on behalf of developers,Exploring legal challenges, though potentially premature without final action, remains an option,Raising public awareness through media campaigns is suggested, emphasizing the benefits of LDTs and drawbacks of proposed regulations. Collaboration with healthcare providers to gather real-world evidence and testimonials strengthens the developers' case. Lastly, engaging in congressional lobbying harnesses legislative power to potentially alter or block the FDA's proposals. Despite the FDA's focus on patient safety, developers are presented with a multi-pronged approach to effectively challenge and shape the outcome of the regulatory process.

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Division of Clinical Microbiology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the Food and Drug Administration's (FDA) progress on making a final rule around regulating laboratory-developed tests (LDTs). Their discussion includes:How the FDA's proposed rule on regulating LDTs has advanced to the White House Office of Management and Budget (OMB) for review, and what to expect in the coming months.Ongoing work around the Saving Access to Laboratory Services Act (SALSA).How laboratorians and pathologists can stay engaged on these important issues. 

In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA's long-awaited proposed rules that actively regulate laboratory developed tests (LDTs). LDTs have historically not been subject to significant regulatory oversight, and while the FDA aims to promptly release the final rule on this intricate issue laden with complexities, potential roadblocks may delay its course of action. Bridgette, Joanne, and Ben discuss this and also cover: • What is a laboratory developed test (LDT) • Where LDTs sit from a regulatory perspective • What industry stakeholders are saying about these rules • What the proposed rules mean • Why the FDA is stepping in now

For many years FDA has claimed the authority to regulate Laboratory Developed Tests, that is tests that are designed, produced, and used in a single lab – never being put up for sale. This authority, however, has been contested, and the FDA itself has traditionally practiced “discretionary enforcement,” wherein it has regulated LDTs very little. A change occurred in October 2023 when the FDA issued a notice of proposed rulemaking wherein it indicated its intention to codify its claim of authority and begin enforcing oversight of LDTs. Dr. Joel Zinberg, M.D., J.D., joined us to discuss the history the FDA’s regulation of LDTs, the proposed rule, and what the ramifications may be. Featuring: Dr. Joel Zinberg, Senior Fellow, Competitive Enterprise Institute

Join Ropes & Gray's life sciences attorneys for a podcast series exploring regulatory, compliance, and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2024. In this first episode, we focus on key issues to watch related to FDA enforcement and litigation in 2024. These include potential litigation over FDA's planned final rule to regulate laboratory-developed tests (“LDTs”), the Supreme Court's review of FDA's approval of mifepristone for medication abortion, litigation related to FDA discouraging the use of ivermectin in humans during the pandemic, and the potential effects of organizational changes in FDA's Office of Regulatory Affairs (“ORA”) on inspections and enforcement.

Benjamin Zegarelli, counsel with Mintz, gives some important regulatory updates surrounding laboratory-developed tests, artificial intelligence, and software. Oh yeah, we talk about a little thing called EU MDR in this new episode of Let's Talk Medtech.

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, to discuss the U.S. Food and Drug Administration's (FDA) proposed rule on laboratory-developed tests (LDTs) and the comments Mayo Clinic submitted to the FDA.Their discussion includes: How Mayo Clinic responded in its comments to the FDA on the proposed rule on LDTs. What comes next after the public comment period has closed effective Dec. 4. Quality management systems that are currently in place for laboratories. How changes in regulation could impact laboratory operations, patient care, access to testing, and innovation.

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. In today's episode, we have several news stories to cover. Let's dive in.## Barrier to Accessing Cell and Gene TherapiesA webinar is being promoted that focuses on the barriers to accessing cell and gene therapies and strategies for improvement. The webinar discusses the importance of patient services in successful launches of these therapies, emphasizing the need for flexible patient support. Cell and gene therapies are one of the fastest-growing sectors in therapeutics, but patients face unique challenges in accessing them that pharma brands must address. This content was created by members of the StudioID expert network for a sponsor of the publication.## Global Oncology Trends and Clinical Trial StrategiesAn insight brief is being promoted that discusses global oncology trends and their impact on clinical trial strategies. It highlights that 70% of the research and development pipeline in oncology is driven by biotech companies. The brief covers key areas such as early phase trial design, platform design trials, and diversity planning in protocols. It provides insights on how global oncology trends are affecting sponsors and offers strategies for success. The text also mentions opportunities for industry professionals to reach a wide audience through Biopharma Dive.## FDA Comments on Lab-Developed Tests RuleThe FDA has received over 19,000 comments on its proposed rule for lab-developed tests (LDTs). The American Clinical Laboratory Association expressed concerns about the proposal in a 107-page document. Baxter has issued a safety notice regarding syringe infusion pump errors, providing reinforced guidance to mitigate risk. Intuitive, a robotic surgical systems manufacturer, has launched a $150 million venture capital fund to support early-stage companies focused on healthcare access. ResMed, a sleep apnea device manufacturer, is focusing on growing demand for its products with a new executive team. Nevro, a medical device company specializing in chronic pain treatment, has acquired Vyrsa, a low back pain company, for $40 million.## Manufacturing Strategies and Racism in HealthcareAn infographic highlights key manufacturing strategies to boost medtech revenue. Additionally, a survey finds that Black Americans expect to face racism in the doctor's office. Medtech Dive provides in-depth journalism and insight into the most impactful news and trends shaping the medical technology industry.## Potential Merger and Job CutsA potential merger between health insurers Cigna and Humana could face regulatory hurdles due to antitrust concerns. Mass General Brigham has made cuts to its tech division, affecting fewer than 20 employees. The Centers for Medicare and Medicaid Services (CMS) has stated that states could lose funding due to issues with Medicaid redeterminations. Fitch Ratings predicts a deteriorating outlook for nonprofit organizations in 2024. A healthcare data breach at a New York-based imaging center may have exposed the personal information of over 600,000 individuals.## Johnson & Johnson's Drug Sales and CEO AppointmentJohnson & Johnson is pitching investors on the potential sales growth of its cancer and immune disease drugs. CRISPR is shifting its focus from cancer to autoimmune diseases in its cell therapy plans. BrainChild Bio aims to develop cancer drugs, starting with pediatric brain tumors. Pfizer has completed enrollment in a clinical trial for its Lyme disease vaccine. BIO has appointed John Crowley as its new CEO to challenge Medicare's new drug pricing powers.## Johnson & Johnson's Sales Growth and CRISPR's PipelineJohnson & Johnson expects sales growth to slow in 2024 as its blockbuster drug Stelara faces competition. CRISPR is reorganizing its CAR-T pipeline ahead of the FDA's landmark decision. Roche's BTK inhibitor multiple sclerosis program i

This show was recorded 30 November 2023 and can be viewed on our website ⁠⁠⁠⁠here⁠⁠⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠. We have a ton of on-demand content there, too. Thank you for tuning in!

This installment of Ropes & Gray's podcast series Non-binding Guidance focuses on FDA's proposed rule that would affirm the Agency's position that laboratory developed tests (“LDTs”) are in vitro diagnostic products regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”). In this episode, hear from Greg Levine, Josh Oyster, and Beth Weinman, industry-leading attorneys from Ropes & Gray's life sciences regulatory and compliance team based in Washington, D.C., as they discuss FDA's proposal to phase out the enforcement discretion policy it has historically applied to most LDTs. 

The FDA's recent decision to cease its enforcement discretion for lab-developed tests (LDTs) has significant implications for developers. To ensure compliance, developers must adhere to a rigorous process. Key steps include:1) Develop a risk-based framework- 0:39- 1:032) Get pre-market clearance or approval- 1:04- 1:373) Quality control and quality assurance- 1:38- 2:044) Adhering to FDA guidelines for labeling and marketing- 2:05- 2:215) Ensuring data security and patient privacy- 2:22- 2:436) Conducting post-market surveillance- 2:44- 3:037) Staying proactive in meeting new compliance requirements- 3:04- 3:20 For expert guidance on FDA approval and regulatory clearance, contact Darshan Kulkarni at 302-252-6959. 

Tests that are designed in-house to fulfill a clinical need (but aren't FDA approved) qualify as laboratory developed tests. And these LDTs are currently regulated by CLIA. But the FDA is proposing a new rule that would give them oversight of the design and development of laboratory developed tests. So, what does that mean for us? How would this new legislation impact everyday practice inside the lab? On this episode of the podcast, your hosts, Ms. Kelly Swails, MLS(ASCP), and Dr. Ali Brown, MD, FASCP, are joined by Dr. Gregory Sossaman, MD, Clinical Pathologist and Service Line Lead for Pathology and Lab Medicine at Ochsner Health, Dr. Jonathan Genzen, MD, Clinical Pathology Professor at the University of Utah and Chief Medical Officer and Senior Director of Government Affairs at ARUP Laboratories, and Mr. Matthew Schulze, Senior Director for the Center for Public Policy at ASCP, to discuss the implications of the proposed FDA regulations for LDTs. Our panelists share their anxiety around the labor and costs involved in complying with the new rule and describe how lab professionals might be forced into situations where we deny care due to regulations. Listen in to understand why public opinion favors the proposed rule and learn how to share your concerns with the FDA during the public comment period from October 3rd to December 4th, 2023. Topics Covered  · How tests that are not FDA approved but designed in-house to fulfill a clinical need fall into the category of laboratory developed tests· Examples of common LDTs used in academic medical centers + large community health systems· The current regulations re: performance standards for LDTs under CLIA· Dr. Sossaman, Dr. Genzen & Mr. Schulze's concerns around the labor and costs involved in complying with the proposed FDA rule· The lack of clarity re: what modifications to FDA approved tests would be allowed under the proposed regulations· How direct-to-consumer testing, the pandemic and technological advances influenced the proposed FDA rule and why the general public is in favor of it· How the proposed FDA regulations would affect our ability to respond in future pandemicsConnect with ASCPASCPASCP on FacebookASCP on InstagramASCP on Twitter Connect with Dr. SossamanDr. Sossaman on LinkedIn Connect with Dr. GenzenDr. Genzen on LinkedIn Connect with Mr. SchulzeMr. Schulze on LinkedIn Connect with Ms. Swails & Dr. BrownMs. Swails on TwitterDr. Brown on Twitter ResourcesASCP Membership 2024Proposed FDA Regulation of Laboratory Developed TestsPublic Comment on the FDA's Proposed RuleInside the Lab in the ASCP Store 

Description:In this episode, host Etienne Nichols and Shannon Bennett, a regulatory affairs expert in the diagnostic testing space dive into the FDA's proposed rules for Laboratory Developed Tests (LDTs) and In Vitro Diagnostic products (IVDs). Shannon breaks down the past and present regulatory landscapes of LDTs, the differences between IVDs and LDTs, and what the FDA's changes could mean. They discuss the cost implications and the learning curve for labs new to FDA's processes. Shannon explains the FDA's four-year phased plan for labs to comply with the new rules, touching on the challenges at each phase, like the administrative burden and the influx of submissions the FDA might have to review. Focusing on the transition for new or modified tests, Shannon emphasizes the need for more guidance from the FDA and educational efforts to help labs understand the new terms and requirements. We also discuss the potential disruption to healthcare and urge labs to actively comment on the draft regulations to the FDA. Through engaging dialogue, this episode is a deep dive into the regulatory shifts in the lab industry, making it a great listen for those in the regulatory and healthcare fields.Some of the highlights of this episode include:Concerns regarding the handling of new or modified tests during the four-year phase-in period, emphasizing the need for clear guidance alongside historical tests.Discussion on a unique approach from the Valid Act called technology certification, aimed at easing submission and review burdens on both labs and the FDA.The significant educational effort required from the FDA to help labs navigate new terminologies and requirements.The potentially disruptive impact on healthcare, given the critical role laboratory testing plays.Encouragement for labs to actively provide comments on draft regulations to the FDA, advocating for a balanced approach to regulatory developments.Year One: The focus is on adverse event reporting, with Shannon suggesting additional FDA guidance to manage irrelevant adverse event reports.Year Two: registration and listing phase is discussed, pointing out the clerical burden on labs despite having most required information.Year Three: The introduction of Quality System Regulation (QSR) or Good Manufacturing Practice (GMP) requirements in year three is explored, with Shannon mentioning some overlap with existing CLIA compliant quality systems but highlighting FDA's additional documentation expectations.Year 3.5 & 4: Shannon delves into the submission of Premarket Approval Applications (PMAs) for high risk, low, and moderate risk tests in year three and a half and year four, underlining the challenge for labs in categorizing their tests and for the FDA in handling a potential influx of 80,000 to 100,000 new submissions.Quote:"I think the bottom line is this will be potentially very disruptive to the healthcare environment. Lab developed tests. There are studies that have shown that 70% of the information in the medical record is due to laboratory testing. So obviously, they play a really important role in the healthcare environment." - Shannon BennettReference Links:Shannon Bennett on LinkedInIVDs and LDTs: What's the Difference?FDA Proposes New Rule to Regulate LDTs...

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the U.S. Food and Drug Administration's (FDA) recently proposed rule that if finalized, would phase out its current enforcement discretion used for laboratory developed tests (LDTs), and regulate all laboratory tests as medical devices regardless of where they are manufactured.Their discussion includes: A brief history of the FDA's oversight of LDTs and related legislative efforts. The notice and comment rulemaking process that will occur over the next 60 days, and how to submit public comments to the FDA. How this proposed rule may impact laboratories.

Deb Godes and Rachel Stauffer join the Breakroom to discuss the newly released FDA proposed rule on laboratory developed tests (LDTs), stakeholder input the agency is seeking and how Congress may react to the rulemaking. For more information on the LDT proposed rule, read our +Insight and Regs&Eggs blog.

Throughout this series, we've talked about the growth of the direct access testing industry and the types of models developed to support the businesses that are using that type of testing. We've covered reimbursement considerations and physician ordering and specimen collection regulations. How does all of this come together to shape the future of the lab testing industry? On the final episode of our four-part series on direct access laboratory testing, Epstein Becker Green attorneys Bob Hearn, James Boiani, and Megan Robertson discuss licensing and operational considerations, as well as where the lab testing industry is headed.   Visit our site for more information and related resources: https://www.ebglaw.com/dhc70   Subscribe for email notifications: https://www.ebglaw.com/subscribe.   Visit: http://diagnosinghealthcare.com.   This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, to discuss the latest update on the U.S. Food and Drug Administration's (FDA) proposed rule to oversee laboratory-developed tests (LDTs) and what that could mean for laboratories.Specific topics of discussion include:  The FDA's recent announcement on a proposed rule that would enable the agency to regulate LDTs, and what may happen next.  The impact that LDT regulation could have on clinical laboratories.  How to stay engaged and informed about regulatory issues.

For many labs, validating their own laboratory-developed tests (LDTs) is the best solution to provide innovative, niche laboratory results in a rapidly changing healthcare environment.  In this episode, Stephanie Whitehead had the privilege of interviewing Michelle Campbell, MS, MLS(ASCP) MB, SC - an accomplished laboratory diagnostic development scientist (and medical laboratory professional) with expertise in developing and implementing laboratory-developed tests (LDTs). Tune in as Michelle discusses the importance of leveraging validated LDTs to help drive innovation, patient safety and quality outcomes.  Listeners are sure to gain valuable insights into tips on developing new tests to meet the evolving needs of your patients!Special Gues Bio:Laboratory diagnostic development scientist and medical laboratory professional with experience in clinical laboratory, academic medical center, and industry settings with expertise in clinical chemistry, immunology, molecular diagnostics and mass spectrometry. ASCP certified Specialist in Chemistry (SC), Medical Laboratory Scientist (MLS), and Technologist in Molecular Biology (MB). Part-time educator (course development and delivery) of graduate studies in biostatistics and laboratory method evaluation.Don't miss out on an opportunity to learn and connect from us!Connect with Michelle here on Linkedin  Michelle's Book Recommendations:Grit, Angela DucksworthAtomic Habits, James Clear Connect with Stephanie WhiteheadClick on the link to connect with Stephanie for more on this and other leadership and personal development topics. Join Team #eLABorate and connect with us!Connect with us on LinkedIn: eLABorate Topics Group and give us your feedback!Podcast Call to ActionWe would love to feature YOU!!!Share your favorite takeaway from today's episode: Video ReviewBe an eLABorate Supporter!1.     Listen on directimpactbroadcasting.com, Spotify, Apple Podcast, or your favorite podcast platform2.     Don't forget to subscribe to the show on your phone, tablet, or notebook so you never miss an episode!3.     Be sure to leave a comment, and share it with fellow medical laboratory professionals!4.     Join our eLABorate Topics Group on LinkedIn5.     Leave us a Video Review and we will feature you on our Social Media: Video ReviewBe a Guest on our show!If you have a leadership or laboratory message to share and would like to be a guest on the show, please reach out to us by completing the guest interest form or send us an e-mail us at elaboratetopics@directimpactbroadcasting.com.

In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation.Mike is the president of Vascular Sciences, has a Ph.D. in biomedical engineering, and has extensive experience with Regulatory Strategy. In today's episode, he begins by reviewing some of the information in Part 1 of this discussion. He discusses how the current regulations and language around LDTs relate to the Theranos situation and what companies should be doing to ensure they're ready when the VALID act goes through. Listen to this episode to hear what Mike has to say about the risks of LDTs, the engineering work that should go into LDTs, and how the regulations could be changed to close the Theranos loophole. Some of the highlights of this episode include:The risk behind LDTs vs IVDsWhether LDTs belong in the IVD categoryThe relationship between the LDT situation and TheranosPrinciples to use with LDTsWhat companies should be doing now in anticipation of the VALID actThe importance of a contingency planThe criteria for a legitimate LDTSpecific parameters to define an LDTLabelingTechnologyRiskRequiring hospitals to put LDTs through institutional review boardsBetter oversightCreating a EUA-like pathwayMemorable quotes from Mike Drues:“Even from a technology perspective, the technology of these LDTs is becoming much much more complicated.”“Long story short, I think Theranos took a fairly liberal interpretation of the words surrounding the LDT.”“I'm a biomedical engineer first and a regulatory consultant second. And that's the order we should think about these things.”“Even though I'm a regulatory consultant, I'm not a fan of creating new regulation.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What's the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic.Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strategy, the FDA, and the history behind most of the regulations. In today's episode, Mike Drues and I spoke about the topic of Lab Developed Tests (LDTs), the ongoing Theranos case, and the state of LDTs & IVDs.Listen to the episode to learn more about Lab Developed Tests and what some examples of them are, what testing and regulations are required for LDTs, and how Theranos was able to market a test without the typical testing rigor. Some of the highlights of this episode include:Why Lab Developed Tests fit in with medical devicesWhat the difference is in LDTs and IVDsHow LDTs are regulatedExamples of LDTsWhy labs develop their own testsThe risk when it comes to LDTsWhy non-invasive LDTs can be listed as class 3Memorable quotes from Mike Drues:“A lot of people like to talk about what FDA regulates. I like to talk about what FDA doesn't regulate.”“Remember, regulation is about the interpretation of words.”“There is no difference in terms of the technology between an IVD and an LVT. The difference primarily is who uses it and where it's developed.”“If the hospital does one thing, they're treated one way; if a company does exactly the same thing, they're treated another way. Something's not quite kosher about that logic.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue to discuss lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. How would FDA oversight impact quality and timeliness of care? How do LDTs relate to what happened with Theranos? Specifically, the following questions are addressed between the two parts of this podcast presentation:Can you start today's conversation by explaining why we've selected this topic for today's discussion? Has there been an update to this debate?What is an LDT?Why do labs develop their own LDTs?Can you provide a couple of examples of LDTs?Currently, are LDTs regulated? Why and who is involved?You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?Is there precedent we can examine for using enforcement discretion to not regulate LDTs?What is the relationship between LDTs and Theranos?What is your recommendation for companies developing LDTs and/or IVDs?Do you have suggestions for improving the status quo with regard to LDTs?What are the important takeaways from this discussion manufacturers should keep in mind?Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company's products. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the debate over lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. What would this type of oversight do to the need for speed with these types of tests? Would FDA supervision make things safer and also avoid future situations like the Theranos debacle? Specifically, the following questions are addressed between the two parts of this podcast presentation:Can you start today's conversation by explaining why we've selected this topic for today's discussion? Has there been an update to this debate?What is an LDT?Why do labs develop their own LDTs?Can you provide a couple of examples of LDTs?Currently, are LDTs regulated? Why and who is involved?You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?Is there precedent we can examine for using enforcement discretion to not regulate LDTs?What is the relationship between LDTs and Theranos?What is your recommendation for companies developing LDTs and/or IVDs?Do you have suggestions for improving the status quo with regard to LDTs?What are the important takeaways from this discussion manufacturers should keep in mind?Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company's products. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

Given the rise of exciting new therapeutic modalities ranging from mRNA to gene editing, investors would be forgiven for overlooking opportunities in medical devices. They might be worth a closer look though. In this episode of the 7investing podcast, the team's health-care trio provide a high-level overview of the regulatory environment for medical devices, describe why and how genetic tests are regulated as medical devices, and provide three examples of companies in the space and how they fit within the regulatory landscape. Medical devices are regulated by the U.S. Food and Drug Administration (FDA) within three categories: Class I devices are the simplest and least likely to pose safety risks. Examples include bedpans or medical gauze. These require regulatory clearance. Class II devices are more complicated and require more data within their regulatory submissions to ensure the safety and effectiveness of the device. Examples include X-ray machines or knee braces. These require regulatory clearance. Class III devices are the most complicated and pose the greatest potential risk to patients, such as life-supporting, life-sustaining, or implantable devices. Examples include liquid biopsies, pacemakers, or implantable contact lenses. These require regulatory approval. Although Class I and Class II medical devices can be submitted through the 510(k) process and only need to show equivalence to a predicate ("existing") device, Class III medical devices must be submitted through the more rigorous premarket approval (PMA) process that often requires a clinical trial. Unlike a drug candidate that requires at least three separate clinical trials (phase 1, phase 2, and phase 3), a Class III medical device often only requires a single clinical trial. It seems odd, but genetic tests and liquid biopsies are also regulated as medical devices. These product candidates are categorized into one of the classes above, which typically impacts how and where they can be used. The three designations of genetic tests include: Research use only (RUO) products cannot be used as diagnostics and don't require a regulatory submission. RUOs can form the basis of a more advanced diagnostic product from the originator or its customers. These serve an important role, but generally have the smallest market opportunity. Laboratory developed tests (LDT) must be designed, manufactured, and processed by a single CLIA-certified laboratory. These tend to be Class II medical devices and require a 510(k) filing. LDTs are often used with centralized business models, where patient samples are shipped to a centralized facility. Examples include genetic screening tests. These have the largest volume potential, but low to moderate pricing and insurance coverage. These have moderate to large market opportunities. In vitro diagnostics (IVD) are more robust tests and can be shipped to the point of care, which means placed in the hands of doctors, oncologists, and medical facilities. Because these are not self-contained within CLIA-certified labs, they're often classified as Class III medical devices and require a PMA filing and clinical trial. IVDs are often used with distributed business models, where patient samples are processed at the point of care. Examples include liquid biopsies. These have both large volume and high price potential, which results in the largest market opportunities by monetary value. Finally, the podcast concludes with three different examples of medical device companies: 7investing Lead Advisor Dana Abramovitz discusses Inviate (NYSE: NVTA). 7investing Lead Advisor Maxx Chatsko discusses Nano-X Imaging (NASDAQ: NNOX). 7investing Lead Advisor Simon Erickson discusses STAAR Surgical (NASDAQ: STAA) --- Send in a voice message: https://anchor.fm/7investing/message Support this podcast: https://anchor.fm/7investing/support

Given the rise of exciting new therapeutic modalities ranging from mRNA to gene editing, investors would be forgiven for overlooking opportunities in medical devices. They might be worth a closer look though. In this episode of the 7investing podcast, the team's health-care trio provide a high-level overview of the regulatory environment for medical devices, describe why and how genetic tests are regulated as medical devices, and provide three examples of companies in the space and how they fit within the regulatory landscape. Medical devices are regulated by the U.S. Food and Drug Administration (FDA) within three categories: Class I devices are the simplest and least likely to pose safety risks. Examples include bedpans or medical gauze. These require regulatory clearance. Class II devices are more complicated and require more data within their regulatory submissions to ensure the safety and effectiveness of the device. Examples include X-ray machines or knee braces. These require regulatory clearance. Class III devices are the most complicated and pose the greatest potential risk to patients, such as life-supporting, life-sustaining, or implantable devices. Examples include liquid biopsies, pacemakers, or implantable contact lenses. These require regulatory approval. Although Class I and Class II medical devices can be submitted through the 510(k) process and only need to show equivalence to a predicate ("existing") device, Class III medical devices must be submitted through the more rigorous premarket approval (PMA) process that often requires a clinical trial. Unlike a drug candidate that requires at least three separate clinical trials (phase 1, phase 2, and phase 3), a Class III medical device often only requires a single clinical trial. It seems odd, but genetic tests and liquid biopsies are also regulated as medical devices. These product candidates are categorized into one of the classes above, which typically impacts how and where they can be used. The three designations of genetic tests include: Research use only (RUO) products cannot be used as diagnostics and don't require a regulatory submission. RUOs can form the basis of a more advanced diagnostic product from the originator or its customers. These serve an important role, but generally have the smallest market opportunity. Laboratory developed tests (LDT) must be designed, manufactured, and processed by a single CLIA-certified laboratory. These tend to be Class II medical devices and require a 510(k) filing. LDTs are often used with centralized business models, where patient samples are shipped to a centralized facility. Examples include genetic screening tests. These have the largest volume potential, but low to moderate pricing and insurance coverage. These have moderate to large market opportunities. In vitro diagnostics (IVD) are more robust tests and can be shipped to the point of care, which means placed in the hands of doctors, oncologists, and medical facilities. Because these are not self-contained within CLIA-certified labs, they're often classified as Class III medical devices and require a PMA filing and clinical trial. IVDs are often used with distributed business models, where patient samples are processed at the point of care. Examples include liquid biopsies. These have both large volume and high price potential, which results in the largest market opportunities by monetary value. Finally, the podcast concludes with three different examples of medical device companies: 7investing Lead Advisor Dana Abramovitz discusses Inviate (NYSE: NVTA). 7investing Lead Advisor Maxx Chatsko discusses Nano-X Imaging (NASDAQ: NNOX). 7investing Lead Advisor Simon Erickson discusses STAAR Surgical (NASDAQ: STAA) --- Send in a voice message: https://anchor.fm/7investing/message Support this podcast: https://anchor.fm/7investing/support

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at recently proposed legislation regarding in vitro diagnostics and lab developed tests. The previous version of the Verifying Accurate, Leading-edge IVCT Development Act or VALID, which was proposed just before the pandemic, split the industry with the AACC and ACLA not supportive of it, while AdvaMed and CAP were in favor of the proposed legislation. Specifically, the following questions are addressed:First, can you clarify what an IVD and LDT is and what the differences are?How are these currently regulated or how were they regulated?Why is there a call for changes to the regulatory process for these tests.Why is this proposal so divisive to the industry and these organizations?The last time this was proposed, it never even went to a vote. Will this version see the same fate or might this one have a little more support behind it given how important testing was during the pandemic?Listen to this episode and see what you think of the proposed testing regulations. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

a UN Food System Summit & Sourcing Matters project Together, the UN Food Systems Summit and Sourcing Matters launch their new and thought-provoking podcast series, Laying Down Tracks. This inspiring 8-part miniseries, led by Aaron Niederhelman, will feature world experts on issues related to world hunger, malnutrition, climate change, and much more. Focused on the real experiences of rolling out the United Nations Sustainable Development Goals, each episode will bring forward solutions through motivating discussions. We are laying down tracks to head into a new world where our food systems mean prosperity for people and the planet.  Listen now to 'Laying Down Tracks' (LDTs) to learn how you, too, can help save our planet. --- --- LAYING DOWN TRACKS - ep.2:  SUSTAINABLE CONSUMPTION If food waste was a country, it'd be the third biggest global greenhouse gas emitter. “We waste at least a third of the world's food sources. So, a third of all that environmental impact is happening for no good reason, just for food to be left to rot,” said author and activist Tristram Stuart as he joins Aaron Niederhelman as co-host for this second episode. Stuart is known for his craft beer line Toast Ale, which turns a potential food waste magically into beer. That is something we can all cheers to. He is joined by Lana Weidgenant, Deputy Director of Zero Hour International and UN Food Systems Summit Vice-Chair for Action Track 2, and Webster Makombe, a law student and youth activist from Scaling Up Nutrition Movement. Sustainable consumption is becoming more of a priority from each generation to the next says Weidgenant, while Makombe shares how local foods are changing consumption habits in Zimbabwe. Join us to hear all about how you can change your consumption habits – and your beer choice – to create lasting changes in our food systems. --- Host: Aaron Niederhelman Co-host: Tristram Stuart, co-founder of Feedback and founder of Toast Ale Guest: Lana Weidgenant, Deputy Director of Zero Hour International and UN Food Systems Summit Vice-Chair for Action Track 2 Guest: Webster Makombe, law student and youth activist from Scaling Up Nutrition Movement

a UN Food System Summit & Sourcing Matters miniseries Together, the UN Food Systems Summit and Sourcing Matters launch their new and thought-provoking podcast series, Laying Down Tracks. This inspiring 8-part miniseries, led by Aaron Niederhelman, will feature world experts on issues related to world hunger, malnutrition, climate change, and much more. Focused on the real experiences of rolling out the United Nations Sustainable Development Goals, each episode will bring forward solutions through motivating discussions. We are laying down tracks to head into a new world where our food systems mean prosperity for people and the planet.  Listen now to 'Laying Down Tracks' (LDTs) to learn how you, too, can help save our planet. --- --- LAYING DOWN TRACKS - ep.1:  FOOD ACCESS - co-host: Dr. Lawrence Haddad, Executive Director at GAIN - guest: Maureen Muketha, founder of Tule Vyema - guest: youth activist Sophie Healy-Thow One of the exciting things about the summit is that it brings these five different communities together. There’s the community that I’m immersed in; hunger, nutrition, and food safety – but there are these other communities involved. People that are worried about climate, environment, livelihood, and resilience. Food systems affect all of those things, and all of those things affect food systems,” Said Dr. Lawrence Haddad, Executive Director of the Global Alliance for Improved Nutrition (GAIN) and Lead of the United Nations Food Systems Summit Track 1, as he kicks off the conversation as co-host with Aaron Niederhelman. The discussions in this first episode covers a lot of ground, but always seems to return to two subjects: food access, and the involvement of younger people. A successful movement lead by youth takes more than just a retweet or share; it requires meaningful conversations. Maureen Muketha, the founder of Tule Vyema, and youth activist Sophie Healy-Throw join as guests to discuss how to solve big problems tied to food access. Tune-in to hear what’s really going on with your food in this first episode as we begin laying down tracks heading into the UN Food Systems Summit.

After a long break, the world's first genomics pundits are back for the season. And they are calm and collected in the face of the strorm on Pennsylvania Ave. We're sixty days from an election. How serious should we be taking politicization of the COVID vaccine, this radical shift on LDTs at the FDA? We also discuss some regular approvals and on rejection that sent the industry reeling with disappointment. Then it's on to Laura's, Nathan's, and Theral's picks for science of the month. Welcome back!

After a long break, the world's first genomics pundits are back for the season. And they are calm and collected in the face of the strorm on Pennsylvania Ave. We're sixty days from an election. How serious should we be taking politicization of the COVID vaccine, this radical shift on LDTs at the FDA? We also discuss some regular approvals and on rejection that sent the industry reeling with disappointment. Then it's on to Laura's, Nathan's, and Theral's picks for science of the month. Welcome back!

In this week’s podcast, senior reporter Sue Darcey talks about troubling developments for US laboratories and diagnostic test-makers that say the Government Accountability Office was mistaken in conclusions it reached in a recent report about how much labs will be billing Medicare for clinical tests. Also discussed are comments lab associations sent to US legislators, who have been trying to win industry and stakeholder consensus on a regulatory reform proposal for laboratory developed tests (LDTs) that they call the VALID Act. Medtech Insight articles addressing topics discussed in this episode: • Lab Groups Disagree With GAO That Medicare Will Be Overbilled For PAMA Test Payments https://medtech.pharmaintelligence.informa.com/MT124672/Lab-Groups-Disagree-With-GAO-That-Medicare-Will-Be-Overbilled-For-PAMA-Test-Payments

Rubbing shoulders at molecular medicine conferences these days one senses a sigh of relief when you talk about laboratory developed tests (LDTs). With the FDA’s decision to put regulation on hold coupled with the expected confirmation of Scott Gottlieb as FDA commissioner, those in the lab testing business seem to be confidently settling back to the status quo. And those who were arguing that all we need is a “beefed up” CLIA to hold labs to better testing standards don’t appear to be motivated to do so anymore.

As we get closer to the election and the end of 2016, the debate over LDT regulation has gone quiet. At this time last year, there was one hearing after another, first in the Senate, then in the House. The FDA’s Jeffrey Shuren was called before congress and drilled over the nuances of the guidance as well as asked when it would be released. He said, in the first half of 2016.

We set up an interview with David Spetzler, the CSO of Caris Life Sciences, to hear about some promising new liquid biopsy tests they are developing. And we do that in today’s show. But first, the interview takes a turn toward the regulation of molecular tests. Spetzler says that Caris is already doing as many quality certifications as possible short of FDA oversight.

As the FDA works away on final guidance for regulating LDTs, various professional groups unhappy with the course of the FDA have put together and hurried their own proposals up to Captiol Hill. The Diagnostic Testing Working Group (DTWG) has had their proposal drafted into legislation which has already been revised once in the House Energy and Commerce Committeee, while proposals from the College of American Pathologists (CAP) and the Association of Molecular Pathology (AMP) have been presented to both the Senate and the House.

It's no secret that America's molecular testing laboratories by and large are worried that the FDA's plan to regulate laboratory developed tests, or LDTs, will severely harm patients. Now they have a new proposal which they are taking directly to Capitol Hill. Roger Klein is the Medical Director of Molecular Oncology at the Cleveland Clinic. He’s also serving as the spokesperson for the Association for Molecular Pathology (AMP) on the controversial topic of regulating LDTs.

We’re very pleased to have Liz Mansfield of the FDA on the program to finish up our current Special Report on LDTs Series. Liz is part of the team at the FDA working on the new guidance for the regulation of LDTs, and she was at the recent meeting the FDA held to receive community feedback. Today we get into some of the details of that feedback. Did Liz and the FDA hear any new issues that they had not already considered? What about the BRAF testing that was mentioned in the meeting? Is there a risk that patients will lose access to some important tests?

Amy Miller is the Executive Vice President for the Personalized Medicine Coalition (PMC) and joins us in our Special Report on LDTs Series. Though the PMC does not have a position on whether the FDA should regulate LDTs, Amy says that the stakes could not be higher. “We see the future of personalized medicine is at stake. We urge the FDA to get this right the first time so that personalized medicine can continue to improve the quality of care that patients currently have access to,” she says at the outset of today’s interview.

Guest: Elaine Lyon, President, AMP; Director of Genetics Division, ARUP Bio and Contact Info Listen (5:53) How do you determine clinical validity? Listen (5:41) Whole genome or exome?

The US Food and Drug Administration has long maintained its right to regulate LDTs; however until recently they've chosen to exercise discretion and have left this to the individual laboratories and other regulatory agencies. This is now in a state of change, and the FDA has stated that it would issue guidance on its oversight of Laboratory Developed Tests.