Molecular Designs, a physician-founded developer and manufacturer of molecular infectious disease assays, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (K262789) for its SimplicityDx Panel FluA/FluB/RSV, the company's first FDA-cleared assay. The multiplex real-time RT-PCR test qualitatively detects and differentiates influenza A, influenza B and respiratory syncytial virus (RSV) RNA in anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection.
Influenza and RSV often circulate at the same time, and respiratory season can stretch lab capacity. Testing for all three viruses in a single run can help laboratories keep pace during those months. Results are intended as an aid in differential diagnosis, in conjunction with other clinical, epidemiologic and laboratory findings.
"This is a defining moment for Molecular Designs," said Michael Clark, CEO of Molecular Designs. "Earning FDA clearance requires rigorous manufacturing, robust quality systems and scientific discipline, and our team built all three. 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."
The SimplicityDx Panel FluA/FluB/RSV includes influenza A, influenza B, RSV, and an internal control. It is designed to work with Molecular Designs' Simplicity Dx Extraction products.
The panel's breakaway format is designed to let labs use only the tests needed for each run with minimal pipetting. This can help reduce waste and simplify inventory management, which is especially useful for labs with staffing constraints or volumes that swing with respiratory season. The format also supports batch processing for higher-volume days.
"Our goal was never just to add another respiratory test," said Dr. Greer Massey, Chief Scientific Officer of Molecular Designs. "We set out to design one around how clinical labs actually work, with quality and efficiency as priorities from the start. Every choice, from the assay format to the run controls, came from working alongside lab teams and listening to what they need day to day."
The SimplicityDx Panel FluA/FluB/RSV is for prescription use only and for use in laboratories certified under CLIA to perform high-complexity tests. Laboratories interested in the panel can connect with a Molecular Designs representative at https://www.moleculardesigns.com/dx-respiratory.
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