FDA Approves Comprehensive System to Test Donated Blood for HIV, Hepatitis B and Hepatitis C

The Food & Drug Administration (FDA) today approved a new nucleic acid test from Roche to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis B DNA in a single, automated assay. The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative in vitro test for comprehensive single-assay detection of HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, hepatitis C virus RNA and hepatitis B virus DNA in human plasma. The test, which is not intended for use as an aid in diagnosis, is designed to further increase the safety of blood supplies by identifying infections earlier than traditional serology tests.

"Roche is committed to meeting the needs of blood centers with tests and systems that ensure the highest blood safety," said Daniel O'Day, head of Roche Molecular Diagnostics, the business area of Roche Diagnostics that developed the test. "Our multiplex test has been widely adopted and has demonstrated excellent performance in blood centers worldwide. We are pleased to introduce it in the U.S. as we continue to further invest in solutions for this critical industry."

The test runs on the fully automated, real-time PCR cobas s 201 system, designed to increase processing efficiency with a unique modular design and ready to use reagents.

"The Roche MPX test raises the blood industry to a higher level with regard to overall blood safety, process simplification and process control," said Louis M. Katz, MD, executive vice president of medical affairs at Mississippi Valley Regional Blood Center, one of the TaqScreen MPX clinical trials sites. "Our organization looks forward to using the MPX test."

Countries that have implemented NAT testing have demonstrated a reduction in transfusion-related HIV, HBV, and HCV infections. In the U.S. alone, the Centers for Disease Control and Prevention (CDC) estimates that there are more than 1 million people in the U.S. living with HIV/AIDS, with an additional 40,000 people being infected each year. It is estimated that 300,000 infected persons are unaware of their HIV status. More than 4 million people in the U.S. have been infected with HCV, 3.2 million of whom are chronically infected. HCV is the leading cause of liver cancer in the U.S. More than 1,200,000 people are chronically infected with HBV and about 5,000 people die of complications of HBV every year in the U.S. Many individuals with HBV and HCV show no symptoms of disease, and do not know that they are infected.

Source: Roche