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Cepheid announced that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments Waiver approval for Xpert® HCV, the only molecular test in the US to detect hepatitis C virus RNA directly from a human capillary whole blood sample.

Cepheid announced that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus.

Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert ® Xpress MVP.

Danaher Corporation announced it will provide Cepheid’s Xpert® MTB/RIF Ultra diagnostic test cartridges for tuberculosis at Cepheid’s cost of $7.97 each to the Global Fund to Fight AIDS, TB and Malaria and to less-developed countries eligible for Cepheid’s Global Access Program1 to support greater access to high-quality TB testing.

Cepheid, a leading molecular diagnostics company, announced today that Vitor Rocha has officially joined the company in the role of President.

Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration for Xpert Mpox, which runs on Cepheid’s GeneXpert® systems.

Cepheid today announced the availability of Xpert ® GBS LB XC (extended coverage), a molecular diagnostic test for qualitative detection of Group B Streptococcus (GBS) using enriched Lim broth cultures of patient samples.

Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C.