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ALFC Double Feature - Making Lateral Flow Accessible Everywhere

Play Episode Listen Later Nov 19, 2025 29:06

This episode is a double from my visit to the Advanced Lateral Flow Conference. Usability is Innovation: Atomo DiagnosticsAtomo Diagnostics set out more than a decade ago to solve a surprisingly human problem in diagnostics: complexity. Founder John Kelly describes how even the best rapid tests—validated in pristine lab environments—often fail when they reach the real world, where people have no training, and shaky instructions. That gap between laboratory precision and real-world usability has huge implications for reliability, trust, and ultimately regulatory approval.Atomo's core insight is simple: most errors in point-of-care testing aren't biological—they're behavioral. The accessories people use in the field (cheap pipettes, dropper bottles, uncalibrated parts) invite mistakes, and the more steps required, the higher the failure rate. Kelly and his team approached the problem the way a designer might: observe how real users behave, then engineer around human nature instead of fighting it.To validate their approach, they went straight to the source—literally to the community—conducting studies in Africa with low-literacy users who received only picture-based instructions. “If it needs a lot of explanation, it's probably not obvious,” Kelly notes. The goal: build a device that is self-explanatory and self-correcting.Their solution, the Pascal platform, integrates every accessory needed to run a test—lancet, blood collection, and buffer reagent—directly into one cartridge. Instead of multiple steps and parts, users simply collect, press, and go. Each step is interlocked to prevent mistakes; for instance, the reagent button won't activate until blood is correctly loaded. It's engineering that enforces proper sequence, eliminating user doubt and waste.Kelly describes how this design delivers the right volume, in the right order, every time—removing the “what if I did it wrong?” anxiety that undermines confidence in results. It's the difference between a reliable diagnostic and a false sense of security.Atomo's HIV self-test—registered with the World Health Organization and distributed across Australia, Europe, and the UK—has demonstrated greater than 99% concordance between trained and untrained users. The company also supports a blood-based pregnancy test (approved in Europe and Brazil) that detects earlier than urine tests, and they're now developing the world's first active syphilis test, capable of distinguishing between current and previously treated infections.What's equally smart is their business model flexibility. Recognizing that many manufacturers already have validated lateral flow cassettes on the market, Atomo developed a “clip-on” usability upgrade that integrates their collection and buffer technology without requiring full retooling or revalidation—a bridge between old workflows and modern design.Beyond infectious disease, Kelly sees growth in at-home wellness and chronic condition monitoring—everything from testosterone and thyroid tests to celiac screening. The platform's adaptability makes it attractive for home use and clinical trials alike. One example: a pharmaceutical partner using Atomo's device to monitor liver toxicity in patients remotely, reducing clinic visits from three times a week to “only when needed.” It's better for patients, cheaper for healthcare systems, and faster for research.The bigger story here is that usability is innovation. Kelly's approach turns workflow design into a driver of impact. Instead of chasing exotic chemistry, Atomo focused on reliability and trust—two things that ultimately decide whether a test makes it into people's hands.As diagnostics and healthcare move increasingly into the home, Atomo's design philosophy feels ahead of its time. If the pandemic taught us anything, it's that people can and will take responsibility for their health—if we give them tools that make sense.Pitch Competition Finalist: EAZEBIOI also sat down with Ying Chen, founder of EAZEBIO, one of the Innovation Award finalists. Her company's portable strip-based diagnostic platform combines CRISPR and AI to bring precision health to everyone, especially in low-resource settings.The Problem: Reactive HealthcareYing opens by explaining the fundamental flaw she sees in today's healthcare system—it's reactive. We wait for symptoms to become severe before acting. EAZEBIO's mission is to shift the paradigm toward proactive, precision healthcare, emphasizing early detection and personalized intervention. Her team focuses on diseases often overlooked at the root-cause level—metabolic, autoimmune, and cardiovascular conditions.Their aim is to bridge the gap between scientific breakthroughs and universal access, translating biomarker data into actionable health insights. As Ying puts it, “We hope proactive, personalized care can provide health equity for everyone, no matter where they live.”Ying's background is a blend of pediatrics, research science, and business—she holds both a PhD and an MBA. Her experience inspired her to adapt the power of CRISPR from the lab to the home.In their prototype for sepsis detection, EAZYBIO's system uses CRISPR to identify antimicrobial resistance genes—the genetic clues that reveal which pathogen is causing an infection. The test also detects human protein biomarkers, providing a two-layered view of infection and host response.Here's how it works:* The CRISPR complex acts like a molecular “scissor,” recognizing and cutting specific DNA or RNA sequences associated with infection.* These sequences are tagged with a cortisol-based reporter. When the CRISPR cut happens, cortisol is released.* The released cortisol binds to split reporter proteins, generating a visible signal on a lateral flow strip.* An AI-powered app then reads and interprets the signal into a semi-quantitative result.This approach achieves roughly 300x signal amplification compared to conventional lateral flow assays—crucial for fast, reliable results.Sepsis is notoriously time-sensitive; treatment delays of more than three hours can dramatically increase mortality. Ying emphasizes that EAZEBIO's platform could enable clinicians to identify pathogens and select the correct antibiotic within one hour—a potentially life-saving improvement.While sepsis is their initial target, the underlying platform is modular and scalable, enabling future multiplexing for 3–5 pathogens per test. Beyond acute disease, the same technology could support early cancer detection and wellness testing, making high-quality diagnostics as easy as a home pregnancy test.Ying speaks with humility about being a finalist at ALFC, but it's clear the recognition validates EAZEBIO's bold vision. The conference gave her valuable exposure to peers across R&D and manufacturing, as well as insights into where diagnostics are heading over the next decade.Her takeaway? Collaboration and accessibility matter just as much as innovation. “It's not just technology—it's about bringing care to everyone, whether they live in a big city or a rural village.” This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit cclifescience.substack.com

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