FDA Approves Roche's COBAS Tests

The FDA has approved Roche Diagnostics' COBAS AmpliScreen HIV-1 and hepatitis C (HCV) tests to screen cadaveric organ and tissue donations -- the expanded claim for screening blood samples from these donors is in addition to testing whole blood, source plasma and potential living organ donors.

Roche Diagnostics' tests have the potential to help detect and thereby prevent transmission of HIV-1 and HCV, making the blood and tissue supply safer, sooner. Roche Diagnostics' blood and tissue screening tests are based on the company's patented and highly sensitive polymerase chain reaction (PCR) technology, which has become the global standard for fast and reliable replication of minute amounts of genetic material to detectable levels.

PCR technology enables detection of the genetic material of infectious agents directly, making it possible to detect infections earlier in the infection cycle than with immunoassays, often before the person making the donation shows any symptoms of disease.