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Cepheid Gets FDA OK to Market Flu/RSV MDx Assay

NEW YORK (GenomeWeb) – Molecular diagnostics firm Cepheid today announced it has received clearance from the US Food and Drug Administration to market its Xpert Flu/RSV XC assay for determination of Flu A and Flu B and differentiation of respiratory syncytial virus.

The test runs on Cepheid's GeneXpert System and allows hospitals and clinicians to diagnose and differentiate influenza strains and RSV in real time, the Sunnyvale, Calif.-based firm said in a statement. It begins shipping in the US in early December, and is already commercially available in Europe, having received a CE mark in September.

"We employed a novel in silico approach to identify multiple complementary target segments to avoid the effects of seasonal genetic drift and to anticipate emerging novel influenza strains," David Persing, chief medical officer and chief technology officer of Cepheid, said in a statement. "Though simple to perform, Xpert Flu/RSV XC is a highly multiplexed, state-of-the-art test for fast and accurate detection and differentiation of Flu A, Flu B, and RSV infection."

Like influenza, RSV is a common virus that leads to a wide range of respiratory symptoms and is particularly dangerous in infants, young children, and older adults. According to the US Centers for Disease Control and Prevention, RSV is the most common cause of bronchiolitis and pneumonia among infants and children under one year of age.

In September, researchers from Johns Hopkins University published the first validation of the firm's Xpert Flu assay (which does not differentiate RSV) in a population of emergency room patients with acute undifferentiated respiratory illness.

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