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 States calls 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
darwa.peterson@cepheid.com
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SOURCE Cepheid