FDA Authorizes Rapid Point-of-Care Hepatitis C Test

The new testing enables immediate diagnosis and treatment.

The U.S. Food and Drug Administration (FDA) granted marketing authorization to Cepheid for the first hepatitis C virus (HCV) test approved for use in certified point-of-care settings. The Xpert HCV test and GeneXpert Xpress System can now be performed in various facilities, such as substance use disorder treatment centers, correctional institutions, and urgent care clinics, that operate under a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver. Unlike traditional tests requiring samples to be sent to central labs, the Xpert HCV test delivers results within an hour from a fingertip blood sample, enabling immediate diagnosis and potential treatment.

“Despite the existence of a safe and highly effective oral cure for hepatitis C, many people do not know they have the disease… with tools to diagnose and treat patients in the same visit can result in hundreds of thousands more hepatitis C patients being diagnosed and treated, preventing individual disease progression and additional spread of the virus,” said Director Jeff Shuren of the FDA’s Center for Devices and Radiological Health.

As the Lord Leads, Pray with Us…

  • For Director Shuren as he heads the FDA’s Center for Devices and Radiological Health.
  • For Commissioner Califf to be discerning as he oversees the FDA.
  • That the testing would be effective for treating those who contract Hepatitis C.

Sources: Food and Drug Administration

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