Assay Approved to Screen for Hep B
The PROCLEIX ULTRIO assay is now approved to screen donated blood for the Hepatitis B virus. The Food and Drug Administration initially approved this assay in 2006 to assess blood for the Hepatitis C virus, as well as HIV-1 using the company’s semi-automated laboratory instrumentation.
In addition to the expanded disease approval, the system is now indicated to screen tissue, organs, and plasma as well as blood. The assay can be utilized with pools of up to 16 samples or individual blood donations.
This assay is manufactured by Gen-Probe, Incorporated. It is also completed with either semi- or fully-automated systems, both of which are available from Gen-Probe.
The company notes the importance of a screening test for the presence of Hepatitis B. Some of the older tests to screen the blood supply already cleared for marketing do not capture presence of this disease. Hepatitis B is considered to be the most serious liver infection.
Gen-Probe specializes in the development of nucleic acid tests that provide results rapidly and are cost-effective and accurate. Products are intended to diagnose an array of diseases or screen blood that is donated.
Marketing of the product will be completed by Gen-Probe’s partner, Chiron. Chiron is one of the businesses of Novartis.
August 15, 2008 Related topics: Product Approval & Certification, Laboratory Equipment, Diagnostic