Hep B Viral Load Test Cleared
Roche Medical Diagnostics announced FDA approval of a new diagnostic assay (pdf) that quantifies the viral road of Hepatitis B. The COBAS TaqMan is the first test available that determines the amount of circulating Hepatitis B virus DNA in the blood.
The diagnostic assay utilizes automated PCR technology completed in real-time from Roche and is intended for use with the company’s High Pure System. All of the major Hepatitis B genotypes can be assessed with this system.
The COBAS TaqMan can detect disease levels within the ranges specified by the World Health Organization (WHO), the HBV International Standard. It was further calibrated based on the standards determined by WHO. It can additionally detect much higher levels of disease than other tests currently available.
Importantly, the test is able to quantify disease even in the presence of other viral conditions. Almost ten percent of patients with HIV have comorbid Hepatitis B.
This information can tell clinicians the degree of patient’s disease and establish a baseline of Hepatitis B viral load. This can help clinicians determine how patients are responding to therapy. The therapeutic goal for the condition is to make disease undetectable in patient’s blood.
Viral load testing is a current standard for ongoing treatment of both HIV and Hepatitis C. This new test allows the same approach for Hepatitis B. This is critical in light of the fact that Hep B can be a life threatening disease.
September 9, 2008 Related topics: Laboratory, Product Approval & Certification, Laboratory Equipment, Diagnostic, Hematology & Oncology