Swiss biotech giant Roche has launched cobas HPV for use on the cobas 6800/8800 systems for cervical cancer screening in European markets accepting the CE mark for health, safety and environmental protection standards.
Cobas HPV is currently the only HPV assay approved by the U.S. Food and Drug Administration (FDA) that offers specific genotyping information for HPV 16 and 18, the two HPV subtypes with highest risk. In addition, the exam can detect 12 other high-risk HPV types as a pooled result. The FDA approved Roche’s test in April 2014 as a first-line primary screening test for cervical cancer in women 25 and older, and it is now approved for ASC-US reflex and co-testing.
By detecting women infected with HPV, the cobas HPV test helps to identify at-risk women before cancer or pre-cancer develops. The ATHENA trial— which looked at cervical cancer screening strategies with cobas HPV test on the cobas 4800 System compared to Pap test alone — found that screening with the HPV test detects more high-grade disease.
Countries are increasing the use of HPV DNA screening in front of Pap cytology as part of national cervical cancer programs.
“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,” Roland Diggelmann, CEO of Roche Diagnostics, said in a press release. “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.”
The cobas 6800/8800 Systems are next-generation molecular testing platforms, available in medium- and high-throughput models. The new DNA assay, Cobas HPV, adds to the growing list of CE-approved assays running on the cobas 6800/8800 Systems, giving laboratories the ability to run HPV DNA testing simultaneously with other cobas assays. These include Chlamydia and Gonorrhea (CT/NG), HIV-1, HCV, HBV, CMV, plus three next-generation assays for donor screening: cobas MPX, cobas WNV and cobas HEV.