Press release summary
BIRMINGHAM, Ala. — Molecular Designs said Nov. 13 that the U.S. Food and Drug Administration granted 510(k) clearance, K262789, for the SimplicityDx Panel FluA/FluB/RSV, the company’s first FDA-cleared assay.
The multiplex real-time RT-PCR test is designed to qualitatively detect and distinguish influenza A, influenza B and respiratory syncytial virus RNA from anterior nasal swabs collected from patients with signs and symptoms of respiratory infection. The panel includes an internal control and is intended to work with the company’s Simplicity Dx Extraction products.
Molecular Designs said the panel uses a breakaway format so laboratories can run only the number of tests needed, with minimal pipetting and support for batch processing. The company said that approach may reduce reagent waste and inventory pressure when respiratory testing volumes fluctuate.
Why it matters: Flu and RSV often circulate at the same time, so a single cleared panel can help high-complexity clinical laboratories consolidate seasonal respiratory testing. The authorization is limited to prescription use in CLIA-certified high-complexity laboratories; the release did not provide clinical performance tables, turnaround time, pricing or a commercial launch date.
Read the original Nov. 13 release from Molecular Designs via PR Newswire.
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