Launch of cobas HPV on the cobas 6800/8800 Systems for cervical cancer screening

• More than 99 percent of cervical cancers are caused by a persistent high-risk HPV infection1

• cobas HPV assay helps to provide critical screening in identifying women at risk, before pre-cancer or cancer develops

• cobas 6800/8800 Systems deliver full automation, helping laboratories meet the throughput that high volume, HPV DNA screening programs demand

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 ability to run HPV DNA testing simultaneously with other previously released cobas assays including: 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.

As demonstrated by the prospective clinical study “ATHENA” comparing screening strategies using 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 pre-cancer or cancer develops, is an important prevention strategy as it helps maintain screening efficiency and helps protect women from the potential harms of overtreatment. Countries are increasingly looking to adopt HPV DNA screening ahead of Pap cytology as part of their 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,” said Roland Diggelmann, CEO 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 fully automated cobas 6800/8800 Systems provide the fastest turn-around time, highest throughput and the longest walk-away time compared to other automated molecular platforms, giving laboratories the flexibility to adapt to changing testing demands.

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*Not all products and uses are available in all countries. Please refer to the package insert for applicable intended uses for each individual product.

References

1. Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999; 189:12-19.