Cepheid Receives FDA Authorization with CLIA Waiver for Xpert® HCV

Detection of hepatitis C virus (HCV) in about an hour

SUNNYVALE, Calif., June 27, 2024/PRNewswire/ -- 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 the US to detect hepatitis C virus RNA directly from a human capillary whole blood (fingerstick) sample. The Xpert HCV test is performed on the GeneXpert Xpress System.

In the United States, 2.4 million people are estimated to be living with hepatitis C and more than half of the people with HCV do not know that they have the virus¹. An HCV RNA test at the point of care can simplify testing algorithms, increase diagnosis rates, and support timely linkage to care and treatment.

The Viral Hepatitis National Strategic Plan for the United Statescalls for greater than 80% of people with hepatitis C to achieve viral clearance by 2030². Currently, the clinical care pathway for detection of hepatitis C faces many barriers, including complicated multi-step diagnostic algorithms based on antibody screening and RNA confirmation³. These algorithms require centralized testing technologies that may result in treatment delays and loss-to-follow up and could discourage at-risk populations from accessing testing and receiving care. Xpert^® HCV can accurately detect active HCV infection from individuals at risk and/or with signs and symptoms of HCV infection with or without antibodies to HCV from a capillary blood sample.

"This simple to use test detects the full range of known HCV genotypes in about an hour and can be performed on a small volume of blood collected via fingerstick," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Scientific Officer.

"This is the first HCV RNA detection technology sensitive enough for active case finding at the point of care. This enables diagnosis of HCV and facilitates timely linkage to care within a single clinic visit - and with this, the potential for treating more people with HCV," said Vitor Rocha, President of Cepheid.

For more information about Xpert^® HCV visit www.cepheid.com

About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.

¹ US Department of Health and Human Services. https://www.hhs.gov/hepatitis/learn-about-viral-hepatitis/data-and-trends/index.html Accessed June, 2024

² US Department of Health and Human Services. Viral Hepatitis National Strategic Plan for the United States: a roadmap to elimination for the United States, 2021-2025. Washington, DC: US Department of Health and Human Services; 2020. https://www.hhs.gov/sites/default/files/Viral-Hepatitis-National-Strategic-Plan-2021-2025.pdf

³ Grebely et al. Hepatitis C point-of-care diagnostics: in search of a single visit diagnosis. Expert Rev Mol Diagn. 2017 Dec;17(12):1109-1115. doi: 10.1080/14737159.2017.1400385. Epub 2017 Nov 8.

For Cepheid Media Inquiries:
Darwa Peterson
[email protected]

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