FDA Clears New Flu, RSV Dx Molecular Test

Cepheid announced it has received clearance from the Food and Drug Administration (FDA) to market Xpert Flu/RSV XC, a molecular test for determination for Flu A and B, and differentiation of respiratory syncytial virus (RSV) infection.

Xpert Flu/RSV XC test utilizes a novel in silico method to identify multiple complementary target segments. Study authors reported that this approach helps avoid the effects of seasonal genetic drift and helps anticipate future new strains. Real-time results will allow healthcare professionals to efficiently diagnose and differentiate influenza strains vs. RSV.

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Xpert Flu/RSV XC runs on the the company's GeneXpert system. Shipments of the test will begin in early December.

For more information call (888) 838-3222 or visit Cepheid.com.