FDA Approves New Human Papillomavirus Test

SUMMARY The FDA this week approved Roche's new human papillomavirus test, which identifies genotypes of cancer-causing HPV types 16 and 18, as well as detecting 12 other high-risk types.

Human papillomavirus (HPV) is common in the population at large, and several studies have shown that it is more persistent and more likely to cause abnormal cell changes in people with HIV. High-risk HPV types including 16 and 18 can cause cervical, anal, and other types of cancer.

Screening for high-risk HPV, along with regular cervical Pap smears to detect abnormal cells, can identify potentially pre-cancerous changes at an early, more treatable stage. A growing number of experts believe that people with HIV can also benefit from anal Pap smears to detect developing anal cancer.

Below is an edited excerpt from a press release from Roche describing the new HPV test, which was developed to detect high-risk cervical HPV but could also potentially be used to identify people at risk for anal cancer.

FDA Approves Roche's HPV Test for Identifying Women
at Highest Risk for Cervical Cancer

Basel, Switzerland -- April 20, 2011 -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved the cobas HPV (Human Papillomavirus) Test which identifies women at highest risk for developing cervical cancer. This test will help physicians make early, more accurate decisions about patient care, which may prevent many women from developing this deadly disease.

The cobas HPV Test is the only FDA-approved cervical cancer screening test that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing. It individually identifies genotypes 16 and 18, the two highest-risk HPV genotypes responsible for more than 70 percent of cervical cancer cases, while simultaneously detecting 12 other high-risk HPV genotoypes. The approval was based on data from the ATHENA study involving more than 47,000 women in the U.S. Results demonstrated that 1 in 10 women, age 30 and older, who tested positive for HPV 16 and/or 18 by the cobas HPV Test actually had cervical pre-cancer even though they showed normal results with the Pap test.

"The FDA approval of the cobas HPV Test demonstrates the value of simultaneous HPV 16 and 18 genotyping in cervical cancer screening," said Daniel O'Day, Chief Operating Officer of Roche Diagnostics. "We look forward to working with laboratories and physicians to introduce the cobas HPV Test into routine cervical cancer screening."

More than 55 million Pap cytology ("Pap smear") tests are performed in the U.S. annually. Current guidelines for screening allow for either cytology or cytology plus HPV testing to determine the risk of cervical cancer. However, HPV testing, and 16 and 18 genotyping in particular, identifies more women at risk earlier than Pap cytology testing alone.

"Screening for high-risk HPV genotypes provides important additive information to Pap testing, and screening for the two highest risk types, HPV 16 and 18, can provide predictive information about a woman's risk for having cervical pre-cancer or cancer," said Mark H. Stoler, MD, Professor and Associate Director of Surgical Pathology and Cytopathology, at the University of Virginia Health System. "The cobas HPV Test provides physicians with a validated tool that helps them make early and more informed decisions regarding patient care."

About the cobas HPV Test and cobas 4800 System

The cobas HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the other high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). It is now available in the U.S. and all countries accepting a CE mark.

The cobas 4800 System is designed to deliver new standards in laboratory testing efficiency and medically relevant diagnostic information. The system offers true walk-away automation and can run up to 282 tests in less than 12 hours, providing rapid analysis of screening tests for HPV infections meeting the needs of the majority of clinical labs.

About Human Papillomavirus and Cervical Cancer

Persistent infection with human papillomavirus is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. According to the National Cancer Institute, there are 12,200 new cases of cervical cancer in the United States annually and 4,210 deaths due to the disease. The World Health Organization estimates there are 470,000 new cases of cervical cancer annually.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

4/29/11

Source
Roche. FDA Approves Roche's HPV Test for Identifying Women at Highest Risk for Cervical Cancer. Pres release. April 20, 2011.