Health · Pharma & Biotech · 22 hrs ago
FDA clears Molecular Designs test for flu A, flu B and RSV
The FDA cleared Molecular Designs’ first test for detecting three respiratory viruses.
The test identifies and distinguishes influenza A, influenza B and RSV in anterior nasal swab samples from people with respiratory symptoms.
These viruses can circulate at the same time, and one test run can check for all three, which may help laboratories manage demand during respiratory season.
The results are intended to help with diagnosis alongside other clinical and laboratory information, not to be used alone.
The test is for prescription use in high-complexity labs certified under the US CLIA programme.
Laboratories interested in using it can contact Molecular Designs.
The U.S. Food and Drug Administration granted 510(k) clearance to Molecular Designs’ SimplicityDx Panel FluA/FluB/RSV.
The assay is the company’s first FDA-cleared test.
It qualitatively detects and differentiates influenza A, influenza B and respiratory syncytial virus in anterior nasal swab specimens.
The test is intended to aid diagnosis alongside other clinical, epidemiologic and laboratory findings.
It is for prescription use in laboratories certified under CLIA to perform high-complexity tests.
- Who
- Molecular Designs, a developer and manufacturer of molecular infectious disease assays.
- What
- The FDA granted 510(k) clearance to the SimplicityDx Panel FluA/FluB/RSV assay.
- When
- November 14, 2026, according to the article’s publication date.
- Where
- The United States; the FDA granted the clearance.
- Why
- The test detects and differentiates three viruses that can circulate at the same time, supporting laboratory testing during respiratory season.
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- Clearance
- FDA 510(k) clearance, number K262789
- Assay
- SimplicityDx Panel FluA/FluB/RSV
- Targets
- Influenza A, influenza B and RSV
- Specimen
- Anterior nasal swab specimens
- Use
- Prescription use in CLIA-certified laboratories performing high-complexity tests
What people are saying
This is a defining moment for Molecular Designs
With respiratory season underway, we're ready to support labs with a cleared, practical way to test for flu A, flu B and RSV in a single run.
Our goal was never just to add another respiratory test