Monday, July 15, 2024

Hepatitis C Management Transformed with FDA Approval of Cepheid’s Rapid Point-of-Care Test

Similar articles

Hepatitis C virus detection and management have seen a significant advancement with the US Food and Drug Administration (FDA) granting marketing authorization to Cepheid’s Xpert HCV test and GeneXpert Xpress System. This approval introduces the first point-of-care hepatitis C RNA test that can be utilized in various healthcare settings, including substance use disorder treatment facilities, correctional facilities, and emergency departments. The test delivers results in about one hour using a fingertip blood sample and can be deployed in settings with a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver.

The FDA’s approval of this test is poised to revolutionize HCV management by enabling a test-and-treat approach, potentially allowing healthcare providers to offer treatment during the same visit for those who test positive for hepatitis C RNA. This is particularly beneficial in settings where patients might not have easy access to follow-up appointments, such as substance use disorder treatment facilities and correctional facilities.

Historically, hepatitis C testing required samples to be sent to a central laboratory, often resulting in significant delays in diagnosis and treatment initiation. This new point-of-care test aims to streamline the process, improving patient outcomes by reducing the need for follow-up appointments. The ability to provide immediate results and potentially begin treatment during the same visit addresses a critical gap in HCV management and enhances the overall efficiency of healthcare delivery.

FDA Validates Cepheid’s Xpert HCV Test, Emphasizing Importance of Accessible Hepatitis C Diagnostics

The validation of the Xpert HCV test was conducted through the Independent Test Assessment Program (ITAP), part of the National Institutes of Health’s Rapid Acceleration of Diagnostics Tech program. While the test is indicated for adults at risk of hepatitis C, it is essential to note that the FDA cautions about the possibility of false-positive and false-negative results, which could lead to inappropriate treatment or delayed effective treatment. The FDA reviewed the test and system through the De Novo premarket review pathway, designated for low- to moderate-risk devices of a new type.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, emphasized the importance of this approval: “Despite the existence of a safe and highly effective oral cure for hepatitis C, many people do not know they have the disease due partly to the lack of availability of convenient, widespread testing options. Equipping healthcare providers 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.”

Hepatitis C

FDA Approval of Xpert HCV Test Revolutionizes Hepatitis C Detection and Management

The approval of the Xpert HCV test and GeneXpert Xpress System is a critical development for healthcare providers working in various settings. It offers a practical and efficient solution for HCV testing, particularly in environments where traditional laboratory testing is not feasible. By providing rapid results, this test facilitates timely treatment decisions, which is crucial for managing and controlling the spread of hepatitis C.

The success of the Xpert HCV test could pave the way for similar point-of-care diagnostics for other infectious diseases. The ability to quickly and accurately diagnose conditions in a wide range of settings can significantly enhance public health efforts, particularly in underserved and high-risk populations. The collaboration between the FDA, Cepheid, and the Gates Foundation highlights the potential for innovative diagnostic tools to transform healthcare delivery and improve patient outcomes.

The FDA’s approval of Cepheid’s Xpert HCV test and GeneXpert Xpress System marks a significant milestone in the fight against hepatitis C. By providing a reliable, rapid, and accessible testing option, this advancement addresses critical gaps in HCV detection and management. The test-and-treat approach enabled by this technology has the potential to significantly reduce the burden of hepatitis C, prevent disease progression, and curtail the spread of the virus, ultimately leading to better health outcomes for patients across various healthcare settings.


You can follow our news on our Telegram and LinkedIn accounts.

Resource: Food and Drug Administration, June 27, 2024

Subscribe to our newsletter

To be updated with all the latest news, offers and special announcements.

Latest article