Roche, the leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics, has announced that the U.S. Food and Drug Administration (FDA) has approved its cobas® TaqScreen MPX Test, v2.0. This is the first nucleic acid test (NAT) to simultaneously detect and identify HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) including source plasma. This is the only test approved by FDA that can identify the three most critical viral targets in one simple, ready-to-use assay.
The use of this assay on a fully automated system offers workflow advantages to blood and plasma testing centers by eliminating the need for consecutive rounds of testing, and facilitating earlier donor counseling in the event of a positive result.
Roland Diggelmann, COO of Roche Diagnostics said, “Since 1998, Roche has developed assays and systems designed to protect the blood and plasma supply on a global scale. By continually developing these innovative products we are striving for the highest level of safety for patients and efficiency for blood and plasma centers. This latest approval supports that commitment.”
Along with CE Mark and recent approvals in Canada, Brazil, China, and India, FDA approval of the cobas TaqScreen MPX Test, v2.0 supports safety standards of blood and plasma centers worldwide. By utilizing real-time, multi-dye PCR technology, individual specimens are simultaneously detected and discriminated for three viruses, reducing the sample volume required and the turnaround time for donor testing.
Roche blood screening tests are based on Nucleic Acid Amplification Technology (NAT) which offers earlier detection of viruses than traditional serology testing. This established manufacturer has also recently won FDA emergency approval for the LightMix Ebola Zaire rRT-PCR test to detect the type of Ebola that has spread through West Africa. The test uses DNA analysis and can provide results in just over three hours.