Roche Adds FDA-Approved HIV-1 Assay To Its Cobas® 6800/8000 Systems

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Swiss biotech company Roche announced on December 21, 2015 that the FDA has approved the Cobas® 6800 and 8800 Systems from its Pleasanton, California-based Roche Molecular Diagnostics (RMD) for the Cobas® HIV-1 viral load test.

According to the announcement, Cobas® HIV-1 is an in vitro nucleic acid amplification test for quantifying human immunodeficiency virus type 1 (HIV-1) in HIV-1-infected individuals.  According to Paul Brown, Head of Roche Molecular Diagnostics:

“The cobas® HIV-1 test is based on Roche’s unique dual-target technology to simultaneously amplify and detect two separate regions of the HIV-1 genome, which are not subject to selective drug pressure.  The addition of this test on the fully automated cobas® 6800/8800 Systems provides laboratories with a comprehensive virology menu to support physicians in making informed treatment decisions for HIV-1 patients undergoing antiretroviral therapy.”

According to Roche, the cobas® 6800 and 8800 Systems are automated molecular testing systems in the areas of donor screening, viral load monitoring, women’s health and microbiology.  Roche states that the systems are based on Nobel-prize winning PCR technology and can process 384 results for the 6800 System and 960 results for the 8800 System in an eight-hour shift, with up to 96 results within the first 3.5 hours.

6800_8800_Systems

FDA previously approved the two systems for viral load tests for hepatitis B (Cobas® HBV) and hepatitis C (Cobas® HCV) in October 2015 .  According to the press release, Roche plans to expand the menu to include a viral load test for cytomegalovirus (CMV) and other quantitative assays.

Sabrina Wang
Sabrina Wang is an associate in our Orange County office. Ms. Wang received her Bachelor's Degree in Bioengineering in 2007 from National University of Singapore. After graduation, she worked as an engineer developing orthopedic devices in Utah and Singapore. In 2015, Ms. Wang graduated from the University of Virginia School of Law. While attending law school, Ms. Wang served on the Article Review Board of Virginia Journal of Law & Technology in her second year. Ms. Wang was a summer associate at the firm in 2014 and joined the firm as an associate in 2015.
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