The FDA has approved a triple test from Roche ($RHHBY) to simultaneously detect HIV, hepatitis C and hepatitis B in donated blood and blood products. It's the first test approved by the agency to simultaneously test for all three of these blood-borne diseases and is expected to reduce the necessary sample volume and the testing turnaround time.
Dubbed the cobas TaqScreen MPX Test, it was approved by FDA to detect and identify HIV, HCV and HBV in donations of human whole blood and blood components, including source plasma. This is the second version of the test, which offers increased sensitivity.
About a quarter of HIV-infected people in the U.S. also have a co-infection with HCV, according to the Centers for Disease Control and Prevention. This is particularly common among HIV-infected users of injection drugs. Roche expects that the elimination of consecutive rounds of testing will facilitate earlier donor counseling if there is a positive result.
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| Roche's Roland Diggelmann |
"Since 1998, Roche has developed assays and systems designed to protect the blood and plasma supply on a global scale," Roland Diggelmann, COO of Roche Diagnostics, said in a statement. "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."
The test is based on real-time, multidye polymerase chain reaction (PCR) technology. It's an RNA-based test and can be used to screen 6 samples of human whole blood and blood components and of plasma donations in up to 96 samples.
Currently, more than 250 testing centers globally already use Roche systems for blood and plasma screening. This test already has a CE mark and is approved in Canada, Brazil, China and India.
The test runs on the cobas s 201 system which runs a menu of tests including those for West Nile virus, parvovirus B19 (B19V) and hepatitis A virus (HAV). All of Roche's blood screening tests are based on Nucleic Acid Amplification Technology (NAT).
- here is the release