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

| Printer friendly version

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.


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.
Click here to read full bio
View all posts published by Sabrina Wang »

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.