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Roche Expands CE-IVD Claims For Organ, Tissue Testing

By R&D Editors | December 15, 2014

Roche announced that the cobas MPX and cobas WNV assays can now be used for testing of human organ and tissue from cadaveric (non-heart beating) donors, expanding the range of approved uses for the cobas 6800/8800 Systems and assays in markets accepting the CE mark.  The new claims for cobas MPX and cobas WNV allow for pre-transplantation testing of organ and tissue donations, protecting transplant recipients from the donation-related transmission of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and West Nile virus (WNV). 
 
“Testing organs and tissue for transplant with the cobas® MPX and cobas® WNV assays allows healthcare professionals to provide increased safety for patients at a critical point in their lives,” said Paul Brown, head of Roche Molecular Diagnostics. “Providing advanced molecular diagnostic assays on the cobas® 6800/8800 system is part of our comprehensive solution for donor screening and emphasizes our commitment to protecting patient safety worldwide.”
 
Across the European Union, the transplantation of organs from deceased donors is a critical procedure performed for over 30,000 patients each year.  The urgent nature of organ transplant procedures from deceased donors requires infectious disease screening to be carried out as quickly as possible to preserve organ function prior to transplantation. The cobas MPX and cobas WNV assays, in conjunction with the cobas 6800/8800 Systems provide the fastest time to results, ensuring the delivery of accurate, reliable test results to clinicians and patients at critical decision points in a patient’s care.
 
Source: Roche

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