Health Canada has granted a medical device licence for Cepheid’s Xpert HCV VL Fingerstick, a test used to detect and quantify the hepatitis C virus (HCV) from a single blood drop.
This advancement is set to streamline the diagnostic process, facilitating faster access to treatment and monitoring of the virus.
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The fingerstick test aids in diagnosing patients at an elevated risk of HCV infection or those who have already tested positive for anti-HCV antibodies. It is also useful in managing individuals with HCV who are receiving antiviral therapy.
It delivers viral load results within an hour, enabling immediate care.
Cepheid announced that the test will be shipped to Canadian customers this month.
The test is operated on the GeneXpert system, which offers polymerase chain reaction (PCR) testing of the same quality as reference laboratories, and can be used in various settings, including hospitals, medical centres, community health clinics, and physician offices.
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By GlobalDataCepheid president Vitor Rocha said: “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.
“This is the first HCV RNA detection and quantification technology sensitive enough for active case finding at the point of care in Canada. 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.”
Cepheid noted that despite the absence of a vaccine for hepatitis C, the condition can be treated and potentially cured with antiviral medications.
The US-based company operates within Danaher Corporation’s Diagnostics platform. It develops and markets molecular systems, as well as tests.
