Roche and Laboratory Corporation of America®Holdings (LabCorp®) have announced 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.