Roche expands CE-IVD claims for organ and tissue testing for next generation blood screening assays
15 Dec, 2014, 06:00 GMT
-- cobas® MPX and cobas® WNV assays now available for additional specimen screening on the cobas® 6800/8800 Systems
PLEASANTON, California, Dec. 15, 2014 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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.
About the Assays for the cobas® 6800/8800 Systems
Assays for donor screening and cadaveric screening
cobas® MPX is a real-time PCR multiplex test covering five critical viral targets: HIV-1 Group M, HIV-1 Group O, HIV-2, HCV and HBV, from a single sample. It offers real-time detection and identification of HIV, HCV and HBV, eliminating both the need for discriminatory testing and the potential for discrepant results. Plus, the dual-target approach with amplification of separate regions of HIV-1, and dual probes for HCV, improve coverage of new virus variants.
cobas® WNV is a real-time PCR test for West Nile virus (WNV) that is highly sensitive for both WNV lineages 1 and 2. It also provides broad coverage of other flaviviruses that can cause transfusion-transmitted infectious diseases.
cobas® HEV is a real-time PCR test for hepatitis E virus (HEV), providing broad coverage of all 4 major HEV genotypes.
About the cobas® 6800/8800 Systems
The cobas® 6800 and 8800 Systems are fully automated solutions designed for donor screening, viral load monitoring, women's health and microbiology testing. They are available in medium and high throughput models, respectively. Based on the Nobel-prize winning PCR technology, the systems are designed to deliver increased automation and throughput with shorter time to results, providing users with greater testing flexibility to increase overall workflow efficiencies.
The systems provide up to 96 results in less than 3.5 hours, and a total of 384 results for the cobas® 6800 and 960 results for the cobas® 8800 in an 8 hour shift. Both systems allow for mixed batching, making it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas® 6800) and four hours (cobas® 8800) of "work-away" time* with minimal user interaction.
For more information about the systems, please visit www.cobas68008800.com.
* May vary based on workflow demands
About Roche Blood and Plasma Screening
Roche is a leader in the global blood and plasma NAT screening market, which is estimated at almost 800 million CHF. Nucleic acid-based tests enable earlier detection of active viral infections than conventional antibody or antigen assays. Roche's real-time PCR-based nucleic acid assays have been used since 1998 to screen blood and plasma products. Currently, more than 250 testing centers worldwide use Roche's automated systems for blood and plasma screening.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
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For media inquiries please contact:
Bob Purcell, Roche Molecular Diagnostics
888-545-2443
Claudia Panozzo, Austria
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Silvia Zucca, Italy
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Francisco Aguilar-Alvarez, Spain
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Eudes de Villiers, France
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Harald Borrmann, Switzerland
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SOURCE Roche