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28 March 2017

Roche has announced the CE-IVD launch of cobas® HPV for use on the cobas® 6800/8800 Systems for cervical cancer screening. Human Papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk. This HPV DNA assay adds to the growing CE-IVD menu on the cobas 6800/8800 Systems, and gives laboratories the capability to run HPV DNA testing concurrently with other previously released cobas assays including: Chlamydia and Gonorrhea (CT/NG), HBV, HCV, HIV-1, CMV, and three next-generation assays for donor screening: cobas® MPX, cobas® HEV, and cobas® WNV.

Screening with the HPV test detects more high-grade disease than a Pap test alone, as demonstrated by the prospective clinical study “ATHENA” comparing screening strategies using cobas HPV test on the cobas® 4800 System. Finding women at risk, before pre-cancer or cancer develops, is an important prevention strategy, because it helps maintain screening efficiency and helps protect women from the potential harms of overtreatment. Countries are gradually looking to adopt HPV DNA screening instead of Pap cytology as part of their national cervical cancer programs.

Roland Diggelmann, CEO, Roche Diagnostics, said: “In addition to the powerful clinical benefits of the cobas HPV test, Roche now caters to the needs of both low-to-mid volume labs and high-throughput labs who want to consolidate a multitude of validated assays onto a single platform. As laboratories look toward the future, they require systems that provide the highest performance standards that Roche delivers as well as new ways to increase efficiency, which ultimately benefit everyone receiving or providing health care.”

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