Roche's cobas HPV Test receives FDA approval for first-line cervical cancer screening using SurePath preservative fluid

- Roche test is now the only HPV test approved for first-line screening with two most common collection media for Pap tests

- Approval for first-line screening with both SurePath™ preservative fluid and ThinPrep® PreservCyt® solution gives vast majority of healthcare providers and eligible patients in U.S. convenient access to primary HPV testing

News provided by

Roche

Jul 30, 2018, 10:00 ET

TUCSON, Ariz., July 30, 2018 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received U.S. Food and Drug Administration (FDA) approval for the cobas^® HPV Test to be used as the first-line screening test for cervical cancer in women 25 and older using cervical specimens collected in SurePath preservative fluid, a collection medium commonly used for Pap tests. The Roche test is now the only Human Papillomavirus (HPV) test approved for use as a primary (first-line) screening test with both SurePath and ThinPrep PreservCyt Solution, the two types of liquid media used to collect samples for the vast majority of Pap or HPV tests in the U.S.

With this FDA decision, the cobas HPV Test is now approved for all of the cervical cancer screening indications that are supported by professional society guidelines—primary screening in women 25 and older, reflex (follow-up) testing of unclear Pap test results in women 21 and older and co-testing with a Pap test in women 30 and older—with both of the primary collection media types.

"Before today, laboratories did not have an FDA-approved HPV test available that could cover all of the HPV screening options supported in professional guidelines and be used with both of the primary Pap test collection media," said Ann Costello, Head of Roche Tissue Diagnostics. "With this additional approval for the cobas HPV Test, laboratories and clinicians now have an approved option that can be used for all of their HPV screening indications and sample types, so they can more easily provide the most appropriate options for their patients."

The cobas HPV Test, introduced in 2011, helps healthcare providers identify women at risk for cervical cancer by individually identifying the presence of the DNA of HPV genotypes 16 and 18—the two genotypes responsible for about 70 percent of all cervical cancer—and reporting the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample. Roche received the first FDA approval to use an HPV test for primary cervical cancer screening (without an accompanying Pap test) for the cobas HPV Test in 2014. More information about the cobas HPV Test is available at: https://www.hpv16and18.com/index.html

About cobas HPV Test and cobas 4800 System
The cobas HPV Test, clinically validated by the landmark ATHENA study, is approved in the U.S. for use with the cobas® 4800 system, which offers walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency.

In addition to the cobas HPV Test, the cobas 4800 system test menu includes CT/NG (chlamydia/gonorrhea), HSV 1 and 2 (Herpes Simplex Virus), MRSA/SA (methicillin-resistant Staphylococcus aureus and Staphylococcus aureus) and C. difficile, as well as BRAF, EGFR and KRAS mutations.*

More information about the cobas 4800 system and its test menu is available at http://molecular.roche.com.

About Human Papillomavirus and cervical cancer
Persistent infection with high-risk Human Papillomavirus (HPV) is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. HPV testing is used in cervical cancer screening protocols to identify women at risk for developing cervical pre-cancer and cancer.

According to the National Cancer Institute, there are more than 12,000 new cases of cervical cancer in the United States annually and 4,210 deaths due to the disease. The World Health Organization estimates that there are more than 500,000 new cases of cervical cancer annually.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

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

For media inquiries please contact:
Todd Siesky, Roche Molecular Solutions
+1-888-545-2443 (US)
[email protected]

SOURCE Roche