By Pat Vaughan, Ph.D., Chief Operating Officer, DCN Dx
La Jolla set the tone: from “strips and lines” to engineered systems
When we gathered at ALFC 2025 in La Jolla, I opened with a provocation—“LFA is Dead! Long Live LFA!”—not to bury lateral flow but to paint a picture of the transformation in front of us. What made LFAs indispensable during the fight against HIV and malaria, and more recently during the COVID pandemic wasn’t the romance of a colored line; it was a unique mix of manufacturability, cost, and near-patient utility. In 2025 and as we enter 2026, what will sustain LFAs is different: engineered sensitivity, reader-anchored quantitation, connected data, and credible quality systems that integrate point-of-care into the same governance structures as the laboratory. That perspective dominated ALFC’s cross-currents—AI in science operations, manufacturability before scale, and regulatory roadmaps as constraints on product design rather than administrative afterthoughts—and it mirrors the broader market’s pivot from pandemic surge to durable adoption. ALFC 2025 showed where rapid testing is headed. The big idea is simple: lateral flow is no longer just an inexpensive way to get a yes/no answer. It’s becoming an engineered system, inclusive of a strip + reader + software + quality planning, built to deliver trustworthy results anywhere care happens.
From the stage, I argued that the post‑pandemic rebirth of LFA depends on building for users, not just analytes. From hospital-at-home to retail clinics, decentralized healthcare demands consumer-grade usability (UX), i.e. speed, simplicity, mobile integration, trustworthy results, reader-backed outputs, and data pathways that fit into clinical decisions with near-zero friction. I then highlighted global exemplars (e.g., HealthPulse AI deployments verifying RDTs and incentivizing quality care in LMIC pharmacies) and emphasized AI/ML validation and cybersecurity as part of the product and not afterthoughts.
Lateral flow didn’t survive the post-pandemic contraction on nostalgia. It survived because teams learned how to make these tests behave in the real world: readers that support quantitation when it matters, for example, and UX that reduces user-driven variability. The rest of this piece is about where that maturity continues today, and what will separate the next generation of systems from the ones that stall.
Why the market still cares about point-of-care testing
Point‑of‑care testing kept growing in 2025 and is on track to keep rising through 2030. Lateral flow rides that wave because it’s fast, scalable, and now more precise thanks to improvements in readers, materials, and smarter chemistry. The opportunity isn’t in cheaper plastic casings; it’s in better-engineered performance and easier use. The numbers say point-of-care is not a COVID afterglow; it is a long-term reconfiguration of where decisions are made. The global POC market was around $21.8B in 2025 and is projected to reach ~$29.9B by 2033, while lateral flow alone is widely estimated near $8.5B in 2025 with trajectories to $12.5B by 2030. What’s fueling the curve isn’t “cheap tests”; it’s digital readers, multiplex strip designs (e.g., respiratory multiplexes), and AI-assisted interpretation that turn a once-qualitative format into a semi- or fully quantitative decision tool. In the U.S. and Europe, analysts expect the LFA category to approach $6.97B by 2030, consistent with a steady shift of testing from central labs to retail clinics, urgent care, and the home. None of that growth is possible without a technology rethink inside the cassette.
2025 reset quality expectations—and LFAs rose to meet them
Regulators and standard-setters spent 2025 raising the floor for decentralized testing. The CDC’s refreshed waived testing guidance re-centered training, documentation, and good practices in settings that had grown comfortable with rapid tests, while CLIA’s 2025 updates tightened proficiency expectations (e.g., HbA1c accuracy) and clarified personnel qualifications—a reminder that speed never excuses sloppiness. More consequential for lateral flow’s future was the ISO 15189:2022 transition: it pulled POCT inside the lab’s quality system. The outcome is that decentralized testing must be as disciplined as the core lab. That’s a good thing for patient care and for the reputation of rapid tests.
From line to number: the 2025 technology that changed LFA’s center of gravity
In LFA, the strip is only half of the product now. Readers, either phone‑based or dedicated, turn bands into stable numbers by correcting for lighting, camera differences, and user technique. New multiplex designs let a single cassette carry several analyte assays without confusing the user. The result is semi‑ or fully quantitative answers you can act on. Crucially, smartphone/AI readers stabilized the last fragile link—human interpretation—by normalizing lighting, focal distance, and phone variation to produce consistent values in uncontrolled environments. In other words: LFA hasn’t turned into molecular; it has become measurable.
The computational side matured, as well. In one example, teams applying machine learning to CRISPR-Cas13 LFA images reported ~96.5% accuracy across 3,000+ smartphone photos, showing how algorithms can collapse inter-reader variability into a predictable output—exactly what decentralized programs and post-market surveillance need. And pragmatic intensity-normalization methods demonstrate vastly increased precision (reduced CV) across lighting conditions. This is the kind of performance that moves what used to be a prototype or great idea from the bench to a pharmacy shelf. That isn’t glamour; it’s what reliability feels like.
Molecular at the point of care raised the bar that LFAs must clear, giving LFAs a roadmap
While lateral flow is accelerating its ability to quantify, molecular POC testing showed how fast “same visit” can really be. The FDA’s 510(k) clearances and CLIA waivers for Roche cobas® liat multiplex STI panels (CT/NG and CT/NG/MG) in January 2025 delivered ~20-minute PCR diagnoses with a single specimen—an unambiguous win for antimicrobial stewardship and loss-to-follow-up. For LFA teams, these products should not be considered existential threats; they’re design briefs: wherever the clinical question tolerates a little less sensitivity (or budgets demand it), the LFA alternative must offer quantitation, multiplexing, and connectivity good enough to keep workflows intact. That’s where 2025’s reader and strip innovations matter.
At the same time, in a bid to reduce costs for many molecular tests at the point of care, CRISPR and other isothermal amplification diagnostic tools edged closer to the LFA form factor with a lateral flow readout, signaling that instrument-light molecular is no longer a thought experiment. In 2026 and onwards, expect to see these workflows either converge with LFA cartridges or ride alongside them with common reader platform and standardized data interfaces. These are not the answer to all POC settings, but they certainly open additional possibilities and create an awareness of the utility of lateral flow.
Materials and labels got smarter, pushing the biological limits without jumping to PCR
Labels and materials continue to matter. Brighter labels and better materials like membranes are pushing antigen tests toward earlier detection windows, stretching closer to the molecular window without the cost and complexity of amplification. This is where the “LFA is high tech” narrative flips from defense to offense: we’re not clinging to cheapness; we’re engineering signal-to-noise.
The mundane plastic cassette or cartridge also came into focus. Research and product launches of biodegradable and, more importantly, bio-compostable cassette housings (e.g., plant-based formulations) show immense promise at affordable prices. If tenders and ESG screens matter to a product’s revenue modeling, a credible biodegradable housing, paired with paper-based microfluidics, can reduce waste and lower procurement friction. Sustainability isn’t a press release; especially in large consumer-facing programs or ones that rely on government tenders, it can be a source of competitive advantage.
Connected diagnostics, in plain terms
Modern lateral flow tests are no longer “just assays.” They’re expected to plug cleanly into the health data world. In 2025, that expectation stopped being fuzzy. Health systems and regulators increasingly assume that an LFA result is born digital, moves as structured clinical data (not a screenshot or PDF), and flows securely to the places it must go: Electronic Health Records (EHRs) for clinical action, payers for reimbursement, and public health for reporting. Practically, that means building connectivity into the product from day one. For example, your reader (smartphone, other handheld, or benchtop) needs a clean application programming interface (API), it should emit FHIR-compatible data by default, and your data model should be stable enough for hospital IT to trust. Treat the reader and app like a regulated device: define how your AI/ML models are updated without causing performance drift, lock down cybersecurity (encryption, access control, audit trails, incident response), and maintain a living phone/device validation matrix so operating systems and camera changes don’t break your application in the field. Do this early, not during a CLIA-waiver study or hospital rollout because waiting until FDA review, a site’s security audit, or an EU notified-body check to figure out your APIs, security posture, or model-update plan is how timelines slip and confidence in your product erodes. In short: design LFAs as digital medical devices—integrated assay, reader, data, and quality system—so your results are trustworthy, portable, and ready for real-world users and workflows.
The EU gave developers breathing room. Now use it to harden your tech, not to coast
On December 16, 2025, the European Commission proposed targeted simplifications to MDR/IVDR and extended IVDR transitional periods by risk class out to 2027–2029, directly addressing notified body bottlenecks that stalled launches. If you sell into the EU, that is not a holiday; it is a window of opportunity. Use it to finish assay verifications and validations, strengthen reader calibration and compensation for end user environmental variability, and validate quantitation under the real-world variability of phones and lighting. The companies that treat this reprieve as runway will own the market when the clock runs again.
What 2026 and beyond should look like if we’re serious about meeting this moment
If 2025 was lateral flow’s coming-of-age year, then 2026 should be the year we lock in those gains as marketable products. That means reader-first LFAs with calibrated quantitation, robust correction for lighting and ambient conditions, and FHIR-ready APIs as the default, not as promises deferred to a future revision. It also means having a clear plan for model updates and drift control, so AI-enabled interpretation remains a regulated medical device instead of an ongoing science experiment.
Lateral flow will increasingly rely on engineered sensitivity, using advances in materials, labels, and reagents where the real-world problem demands it. The goal is not to turn every LFA into a molecular test, but to capture earlier points in the disease curve without crossing into molecular cost and complexity. At the same time, decentralized testing must be treated as a first‑-lass lab node, with competency tracking, quality oversight, and proficiency participation where appropriate. This isn’t paperwork for its own sake—this is how trust is earned and maintained at scale.
The winners in the next decade won’t be the teams that squeeze a single sensitivity claim over the line. They’ll be the teams that design across the integrated system—assay, reader, data, and quality—while telling a strategic story that clinicians, consumers, and investors can all understand. That story isn’t “we print a strong line.” It’s “we deliver a fast, trustworthy, connected result wherever care happens.”
Underneath that story is the engineering teams like mine at DCN Dx undertake for our clients every day: multiplex strips that leave the development stage without leaving performance behind; labels and chemistries that extend the useful testing window; readers that aren’t fooled by a dim kitchen at 11 p.m.; and quality systems that recognize the home as a legitimate site of care. That is what “Long Live LFA” means in practice. Our team at DCN Dx is proud to embody this ethos, along with the many supply chain partners, diagnostic developers, researchers, and others pushing lateral flow technology forward.
In 2026, I hope that we will all continue doing that.
References
CDC. To Test or Not to Test? Considerations for Waived Testing. July 2025. (CDC lab-quality resource).
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The Biomedical Scientist. Point-of-care testing and the new ISO 15189:2022. Updated July 22, 2024.
Eurachem. ISO 15189:2022 – A new task for medical laboratories (risk-based approach; POCT integration). 2023/2024.
WHO. Updates on the WHO Model List of Essential In Vitro Diagnostics (EDL 5). Open session slides, May–June 2025.
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