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Cepheid’s new molecular test obtains FDA approval

The US Food & Drug Administration (FDA) has granted approval for Cepheid’s molecular test, Xpert Flu/RSV XC.

The molecular test has been developed for accurate determination of Flu A, Flu B, and differentiation of respiratory syncytial virus (RSV) infection.

Cepheid chairman and CEO John Bishop said: "Influenza strains are notoriously unpredictable and the severity of flu outbreaks can vary widely from season to season.

"Recent media coverage of serious viruses such as Enterovirus D68 and Ebola have raised public awareness, and created a greater need for healthcare workers to deliver timely and accurate test results for flu or RSV infection."

The test can be carried out on GeneXpert System, Cepheid’s molecular diagnostic platform with more than 7,500 systems installed across the globe.

Xpert Flu/RSV XC allows hospitals and clinicians to reliably diagnose and differentiate influenza strains and RSV in real-time, said Cepheid.

The company plans to commercially launch the product in early December.

The flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and lungs, while RSV is a common virus that results in a wide range of respiratory symptoms in children and older adults.