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Roche Cobas Assays Get Additional CE Claims for Organ, Tissue Testing

NEW YORK (GenomeWeb) — Roche said today that its Cobas MPX and Cobas WNV assays can now be used for testing of human organ and tissue from cadaveric donors, thus expanding the range of approved uses for the Cobas 6600/8800 systems in markets recognizing CE marking.

The new claims allow for pre-transplantation testing of organ and tissue donations to protect transplant recipients from the donation-related transmission of HIV, hepatitis B virus, hepatitis C virus, and West Nile virus.

In the EU, organ transplantation from deceased donors is performed for more than 30,000 patients annually, Roche said. The urgent nature of organ transplant requires infectious disease screening to be carried out as quickly as possible.

Cobas MPX is a real-time PCR multiplex assay that covers five targets — HIV-1 Group M, HIV-1 Group O, HIV-2, HCV, and HBV — from a single sample. Cobas WNV is a real-time PCR test for West Nile virus that is highly sensitive for both WNV lineages 1 and 2. It also provides broad coverage of other flaviviruses that can cause transfusion-transmitted infections.