Molecular testing is moving to the point of care. Roche said on December 2, 2025 that its cobas liat Bordetella test received FDA 510(k) clearance and a CLIA waiver, with results in about 15 minutes, per the company. On August 6, 2026, Co-Diagnostics announced a dual 510(k) with a concurrent CLIA waiver application for its flu and RSV test.
Why do CLIA waivers decide where a test can run?
A CLIA waiver, not the clearance itself, determines the venue. Under the Clinical Laboratory Improvement Amendments, the FDA categorizes in vitro diagnostic tests by complexity as waived, moderate, or high, and a manufacturer of a moderate-complexity test may request waived categorization through a CLIA Waiver by Application submission providing evidence that the test meets the statutory criteria, per the FDA's regulatory guidance. Once waived, a test can run in sites holding a Certificate of Waiver, which includes physician offices, clinics, and other settings without a full laboratory.
The statutory bar is deliberately strict. The FDA quotes the statute directly: waived examinations must be simple laboratory procedures with an insignificant risk of an erroneous result, employing methodologies so simple and accurate as to render the likelihood of erroneous results by the user negligible. That is why waiver applications carry heavy analytical evidence. Co-Diagnostics said in its submission announcement that the filing was supported by 27 analytical studies, more than 10,000 upper respiratory PCR test runs, and a multicenter reproducibility study across operators, sites, and instruments.
The dual 510(k) plus waiver structure, submitting both together rather than sequencing them, is the strategic choice that separates a lab product from a decentralized one. It front-loads the evidence but lets a company launch directly into near-patient settings if both are granted.
What did the two companies actually disclose?
The two programs, both company-disclosed, compare as follows:
| Program | Status and date | Platform and target | Claimed evidence |
|---|---|---|---|
| Roche cobas liat Bordetella test | 510(k) clearance and CLIA waiver, plus CE IVDR, announced December 2, 2025 | cobas liat system; B. pertussis, B. parapertussis, B. holmesii | Results in about 15 minutes; Roche cites an estimated 24.1 million pertussis cases and 170,000 deaths annually |
| Co-Dx PCR Flu A/B and RSV test | Dual 510(k) with concurrent CLIA Waiver by Application submitted, announced August 6, 2026 | Co-Dx PCR Pro instrument; influenza A/B and RSV multiplex | Clinical study of more than 1,400 symptomatic patients across nine U.S. sites; 27 analytical studies and over 10,000 runs |
The Roche test differentiates three Bordetella species, which matters clinically because B. parapertussis causes a milder pertussis-like illness that may not respond to standard treatments, the company noted. Roche positioned the test against a resurgence context: pertussis is cyclical, peaking in severity every three to five years, with a surge amplified by pandemic-interrupted routine vaccination and waning immunity, per the company's December announcement.
The Co-Dx submission, in turn, is the culmination of a program the company had described on July 1, 2026, when it announced completion of its clinical and analytical performance studies and targeted a Q3 2026 submission. The test runs on a lower-cost instrument and consumable model with cloud-based data aggregation intended to track localized outbreaks, per the company's description.
What does the evidence package reveal about how hard waivers are?
Read side by side, the two disclosures show where the waiver evidentiary burden actually sits. The Co-Dx package rests on three distinct pillars: a clinical study of more than 1,400 symptomatic patients across nine geographically distinct U.S. sites, an analytical program of 27 studies spanning over 10,000 upper respiratory PCR test runs, and a multicenter reproducibility study evaluating performance across multiple operators, sites, and instruments, per the company. The reproducibility leg is the one that exists only because of the waiver: a central-lab test does not need to prove that different untrained users get the same answer in different buildings.
The scale of the analytical program also explains why so few small diagnostics companies reach waived status with multiplex molecular tests. Ten thousand instrument runs and a nine-site clinical enrollment are fixed costs incurred before any regulatory decision, and they are incurred against a submission whose outcome is not guaranteed. Companies structure the work in stages as a result: Co-Diagnostics first announced completion of the studies on July 1, 2026, framing that milestone separately from the submission itself, which followed on August 6.
Roche's clearance, by contrast, shows the other route to the waived setting: a large platform installed base, cobas liat, gaining a new cleared-and-waived menu item. For platform owners, each additional waived assay amortizes regulatory evidence across an instrument fleet that already exists in the field, which is a structural advantage over single-test challengers and a reason the point-of-care molecular menu is growing fastest inside established systems.
What is the commercial logic of decentralized molecular testing?
Respiratory infection testing is the beachhead because the clinical decision is time-sensitive and the alternative is empiric treatment. Roche's release makes the argument explicitly: early pertussis symptoms are often indistinguishable from other respiratory illnesses, and the lack of rapid, accessible diagnostics causes clinicians to treat based on symptoms, a delay the company links to severe outcomes. A 15-minute molecular result in the consultation changes antibiotic stewardship on the spot.
For platform makers, the waived setting is also a volume argument. A central lab buys instruments by the dozens; waived settings number in the tens of thousands of physician offices and clinics, each buying modest but sticky consumable streams. Co-Diagnostics framed its submission as moving toward decentralized PCR diagnostics closer to the patient through a platform designed to improve accessibility, affordability, and ease of use, in the words of its chief executive, Dwight Egan.
The constraint is that waiver-grade accuracy must survive untrained operators, which is why the reproducibility evidence across operators and instruments is the load-bearing part of these applications. Multiplexing adds difficulty: a flu A/B and RSV panel must hold its performance across three targets in a single run, not one.
What should watchers expect next?
The calendar items are the FDA actions. A 510(k) decision and a waiver decision on the Co-Dx submission are the gating events for that platform's entry into waived settings; neither has been decided as of the submission announcement, and no review timeline has been disclosed. For Roche, the launch metric to watch is placement of cobas liat systems into non-laboratory settings, which the company has not quantified.
The broader pattern is durable regardless of individual outcomes: respiratory panels first, because the need and the evidence base are established, with more complex decentralized molecular menus to follow only if the waiver pathway keeps proving that laboratory-grade chemistry can survive a physician-office workflow. Each cleared and waived multiplex strengthens the precedent for the next one.
This article is intended for general informational purposes only and does not constitute medical advice or a recommendation regarding any test, product, or course of treatment.
