Cepheid, Sunnyvale, Calif, has announced receipt of the CE mark for its Xpert HCV VL fingerstick, the first molecular test to detect and quantify RNA levels of the hepatitis C virus directly from a fingerstick blood sample.
Currently, the clinical care pathway for detection of HCV faces many barriers, including complicated multistep diagnostic algorithms based on antibody screening and RNA confirmation.1 The 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.
“Over the past few years, Cepheid, with its collaborators at the Kirby Institute and FIND have been able to demonstrate that a rapid and accurate test for active HCV infection can be performed on a drop of blood,” says David H. Persing, MD, PhD, chief medical and technology officer at Cepheid. “This is the first HCV RNA detection technology sensitive enough for both active case finding and use as a potential test of cure at the point of care.”
Cepheid’s Xpert HCV VL fingerstick test enables a simplified diagnostic pathway. From blood collected into a capillary tube via fingerstick, the simple-to-use test detects and quantifies a wide range of HCV genotypes within 58 minutes. Such a rapid turnaround time makes it possible to diagnose HCV and initiate direct-acting antiviral treatment within a single clinic visit, increasing the potential to cure more people with HCV.2
The new test is now available in the European Union and all countries recognizing the CE mark.
Cepheid is a leading molecular diagnostics company 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.
To learn more, visit Cepheid.
- Grebely J, Applegate TL, Cunningham P, Feld JJ. Hepatitis C point-of-care diagnostics: in search of a single visit diagnosis. Expert Rev Mol Diagn. 2017;17(12):1109–1115; doi: 10.1080/14737159.2017.1400385.
- Lamoury FMJ, Hajarizadeh B, Marshall AD, et al. Evaluation of the Xpert HCV Viral Load fingerstick point-of-care assay. J Infect Dis. 2018;217(12):1889–1896; doi: 10.1093/infdis/jiy114.