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Cepheid obtains FDA 510(k) approval for Xpert Flu+RSV Xpress test

Molecular diagnostics firm Cepheid has received 510(k) approval and clinical laboratory improvement amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for its Xpert Flu+RSV Xpress test for use on GeneXpert Xpress system.

The GeneXpert Xpress is a customized system that features single module and tablet computer with an ATM-like interface, specifically for the CLIA waived environment.

Cepheid chairman and CEO John Bishop said: "There are more than 1 billion visits annually to physicians’ offices in the United States and yet, until recently, CLIA waived testing sites have not had access to the same levels of accuracy found in sophisticated hospital or reference laboratories.

"We believe that point of care testing will be well served by the significant step up in accuracy and multiplexing capability of PCR-based molecular assays and are committed to broadening access to these important tests."

Since November 2014, the Xpert Flu/RSV XC test has been available for CLIA moderate complexity customers.

The Xpert Flu+RSV Xpress test, which uses the same test cartridge as the Xpert Flu/RSV XC test, will be provided to the customers in CLIA-waived settings from this month.

Both tests can detect and differentiate between Influenza A, Influenza B, and RSV, in around one hour.

In July this year, Cepheid launched new portable molecular diagnostics system, GeneXpert Omni, which will help in patient diagnosis suspected of TB, HIV and Ebola.