First high-throughput molecular platform approved for CLIA moderately complex testing expected to enhance quality, streamline workflow and better utilize staff
INDIANAPOLIS, Oct. 24, 2016 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH) announced today that the LabCorp Center for Esoteric Testing in Burlington, N.C., is the first site in the United States to offer commercial testing services with Roche's new cobas® 8800 system. The system automates the entire molecular diagnostics testing process-from specimen preparation and nucleic acid extraction/purification through polymerase chain reaction (PCR) amplification and detection-and is the first high-throughput molecular system to be approved by the FDA for CLIA moderately complex testing.
LabCorp, the world's leading healthcare diagnostics company, is initially running hepatitis C viral load testing on the system and plans to add testing for HIV and hepatitis B virus in the coming months. Because the system enables significant workflow efficiencies, the Burlington site expects to be able to consolidate its virology testing on a smaller number of automated platforms while increasing its testing capacity.
"LabCorp is pleased to be the initial U.S. site to deploy this innovative system in support of our mission to improve health and lives through world-class diagnostics," said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. "Roche's cobas 8800 system automates our virology test process by replacing multiple manual steps to enhance quality and consistency, create a lean workflow and free up staff and space that can be used for additional high-value tasks for the doctors and patients we serve."
"The quality and efficiency gains that moderate complexity testing with full automation offers can be transformational for labs doing molecular testing," said Whitney Green, senior vice president of commercial operations at Roche Diagnostics. "LabCorp is an innovator in adopting new laboratory technologies, and this is another example of how they are taking the lead in driving operational excellence while ensuring quality and patient safety."
About the cobas 6800 and cobas 8800 systems
The cobas 6800 and cobas 8800 systems are fully integrated, automated solutions designed to introduce a new standard for routine molecular testing in the areas of donor screening, viral load monitoring, women's health and microbiology. Based on Nobel prize-winning PCR technology, the systems offer the fastest time to results, the highest throughput and the longest walk-away time available among automated molecular platforms, providing laboratories with improved operating efficiency and flexibility to adapt to changing testing needs.
The systems provide up to 96 results in less than 3.5 hours, and a total of 384 results for the cobas 6800 system and 960 results for the cobas 8800 system in an eight-hour shift. Both make 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 walk-away time with minimal user interaction.
Roche currently offers FDA-approved viral load tests for HIV-1, hepatitis B and hepatitis C on the cobas 6800 and cobas 8800 systems in the U.S. Further menu expansion plans include a viral load test for cytomegalovirus (CMV) and qualitative tests for donor screening, women's health and microbiology. More information is available at www.cobas68008800.com or usdiagnostics.roche.com.
Laboratory Corporation of America® Holdings (NYSE:LH), an SP 500 company, is the world's leading healthcare diagnostics company, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostic solutions, brings innovative medicines to patients faster and develops technology-enabled solutions to change the way care is provided. With net revenue in excess of $8.5 billion in 2015, LabCorp's 50,000 employees serve clients in 60 countries. To learn more about LabCorp, visit www.labcorp.com, and to learn more about Covance Drug Development, visit www.covance.com.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives.
Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognized as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology Life Sciences industry eight years in a row by the Dow Jones Sustainability Indices.
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in RD and posted sales of CHF 48.1 billion. 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 or usdiagnostics.roche.com.
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