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FDA Clears Cepheid Test for Influenza A/B, H1N1

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Cepheid today announced that the US Food and Drug Administration has cleared its Xpert Flu molecular diagnostic test.

The test, which runs on Cepheid's GeneXpert system, simultaneously detects and differentiates Influenza A, Influenza B, and the 2009 H1N1 influenza virus in about one hour, Cepheid said.

Each year, influenza A and B affects about 20 percent of the US population and about 3 million to 5 million people worldwide, the company said, citing statistics from the World Health Organization. It added that between 250,000 and 500,000 people die from the disease annually.

H1N1, first detected in the US two years ago, is no longer at pandemic levels, but is expected to continue to spread for the next several years.

"While seasonal flu strains appear to have been most common this season, the European resurgence of 2009 H1N1 highlighted the need for fast, accurate, and differentiating diagnostics," Preveen Ramamoorthy, director of molecular diagnostics at Advanced Diagnostic Laboratories at National Jewish Health in Denver, said in a statement released by Cepheid. "An easy-to-use molecular flu test can assist clinicians in making real-time medical decisions that can significantly improve patient management."

Quest Diagnostics' Simplexa Influenza A H1N1, which was cleared by the FDA last May, was the first molecular test to receive marketing clearance from the regulatory agency for H1N1.

Xpert Flu is Cepheid's 11th Xpert test to receive FDA clearance, and is CE-marked. The company will begin shipping the test in two weeks.