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news.Roche has received the FDA's approval for its new nucleic acid test, which screens donated blood for HIV-1 group M RNA, hepatitis C RNA and hepatitis B DNA in a single, automated assay.
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The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system, is a 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 expected to be designed to further increase the safety of blood supplies by identifying infections earlier than traditional serology tests, the company said.
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 company added.
Daniel O’Day, head of Roche Molecular Diagnostics, the business area of Roche Diagnostics that developed the test, said: Roche is committed to meeting the needs of blood centers with tests and systems that ensure the highest blood safety.
Our multiplex test has been widely adopted and has demonstrated excellent performance in blood centers worldwide. We are pleased to introduce it in the US as we continue to further invest in solutions for this critical industry.