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Jun 13, 2024 · Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly...
Jun 25, 2024 · Developer of molecular diagnostic testing solutions. The company offers a wide range of tests segregated into three major categories Hospital-acquired infection, Critical Infectious diseases (multi-drug resistant TB (MDR-TB), influenza, RSV, and Enteroviral meningitis) Sexual Health, and Genetic Test (30 Minute Test for Genetic Risk of Thrombosis).
Jun 28, 2024 · Cepheid said Thursday it received de novo authorization for the only molecular test in the U.S. to detect hepatitis C virus RNA directly from fingerstick blood samples. The Food and Drug Administration authorization positions healthcare professionals to diagnose hepatitis C at the point of care.
Jun 27, 2024 · 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...
Jun 27, 2024 · Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for Xpert® HCV, the only molecular test in...
6 days ago · Cepheid is now authorized to market the Xpert HCV tests and GeneXpert Xpress system for point-of-care hepatitis C testing.
Jun 28, 2024 · US-based molecular diagnostics company Cepheid has received the US Food and Drug Administration (FDA) authorisation for its Xpert HCV test.