Roche, Basel, Switzerland, has launched the Cobas HPV assay for use on the Cobas 6800 and Cobas 8800 systems for cervical cancer screening in countries accepting the CE mark.

Human papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk. The HPV DNA assay adds to the growing menu on the Cobas 6800/8800 systems, and gives laboratories the ability to run HPV DNA testing simultaneously with other previously released Cobas assays, including chlamydia and gonorrhea (CT/NG), cytomegalovirus, hepatitis B virus, hepatitis C virus, and human immunodeficiency virus 1, plus three next-generation assays for donor screening: Cobas HEV, Cobas MPX, and Cobas WNV.

As demonstrated by the prospective Athena clinical study comparing screening strategies using the Cobas HPV test on the Cobas 4800 system, screening with the HPV test detects more high-grade disease than a Pap test alone. Identifying women at risk, before precancer or cancer develops, may help maintain screening efficiency and protect women from the potential harms of overtreatment.


Roland Diggelmann, Roche Diagnostics.

“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,” says Roland Diggelmann, CEO of Roche Diagnostics. “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 fully integrated, automated solutions that offer routine molecular testing in the areas of screening, microbiology, women’s health, and viral load monitoring. Based on polymerase chain reaction technology, the systems are designed to deliver full automation, increased throughput, and faster turnaround time, providing users with greater flexibility to increase overall workflow efficiencies.

The systems provide up to 96 test results in less than 3.5 hours. In an 8-hour shift, the Cobas 6800 can produce a total of 384 results, and the Cobas 8800 can produce a total of 960 results. Both make it possible for labs to perform up to three tests in the same run with no presorting required. The systems also enable up to 8 hours (Cobas 6800) and 4 hours (Cobas 8800) of walkaway time with minimal user interaction.

For more information, visit Roche.