Indianapolis, January 8, 2015
SGO, ASCCP leverage newly published end-of-study data to support option of HPV primary screening for women 25 and older
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that three-year end-of-study data from the ATHENA trial published today in Gynecologic Oncology reinforces new interim professional guidance issued by the Society for Gynecologic Oncology (SGO) and the American Society for Colposcopy and Cervical Pathology (ASCCP) to help health care professionals determine how to best incorporate HPV primary screening into cervical cancer screening protocols. The newly issued guidance, published simultaneously today in Gynecologic Oncology and Journal of Lower Tract Genital Disease and Obstetrics and Gynecology, supports HPV primary screening using an FDA-approved test in women 25 and older as an effective alternative to current screening recommendations with the Pap smear alone or co-testing with the Pap smear and HPV testing.
The end-of-study data from the ATHENA trial helped inform the interim guidance report. The data showed that HPV primary screening using Roche’s cobas® HPV Test detected significantly more cervical disease than a Pap test alone. A woman with a negative result from the cobas® HPV Test had less than half the risk of developing cervical pre-cancer within three years than a woman with a negative Pap result.
“The interim guidance represents a new era in women’s reproductive health, particularly for younger women for whom clinicians have typically relied on testing with the Pap alone to detect cervical cancer,” said Alan Wright, MD, MPH, chief medical officer at Roche Diagnostics Corporation. “The new end-of-study ATHENA data supports the guidance recommendations for HPV as an acceptable option for first-line testing because it shows that the cobas® HPV Test had better negative predictive value than the Pap test and increased sensitivity for the detection of pre-cancer, particularly in women age 25 to 29. These data hold great promise for more effectively assessing a woman’s risk of cervical cancer and we look forward to working with other professional societies as they develop official guidelines regarding use of the test as a primary screening tool.”
For the first time, guidance provides clinicians the option to screen women 25 and older with an HPV test, prior to the Pap smear, to identify and stratify risk of cervical disease before it progresses to cancer. The recommendation was informed by a review of 11 studies, including the ATHENA trial, a study of more than 47,000 women that showed an unexpectedly high burden of cervical disease in women age 25-29. ATHENA data demonstrated that more than one-third of all women with CIN3, the highest grade of cervical pre-cancer, were age 25-29. In addition, data found that Pap testing performed poorly in this age group, as more than 50 percent of the CIN3 or worse disease detected in women 25-29 by the cobas® HPV Test was not detected by a Pap test in the ATHENA study.
Interim guidance was developed by the SGO and ASCCP, with input from representatives of five other organizations, including the American College of Obstetricians and Gynecologists (ACOG), American Cancer Society (ACS), American Society for Clinical Pathology (ASCP), American Society of Cytopathology (ASC) and College of American Pathologists (CAP).
About the cobas® HPV Test and cobas® 4800 System
Clinically validated by the ATHENA trial, the cobas®HPV Test is currently the only HPV test approved by the FDA for use as a first-line test in cervical cancer screening. It is also the only FDA-approved HPV test that provides specific genotyping information for HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one run and from one patient sample. The cobas®HPV Test received FDA approval for use as a first-line primary screening test for cervical cancer in women 25 and older in April 2014.
Prior to the expanded indication, the cobas®HPV Test was approved in April 2011 for screening patients age 21 and older with abnormal cervical cytology results and for use adjunctively with normal cervical cytology in women ages 30 and over to assess the presence or absence of high-risk HPV genotypes.
The cobas® HPV Test is performed on the cobas® 4800 System, which offers true walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and realtime PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs the cobas® CT/NG Test (chlamydia/gonorrhea), the cobas® BRAF V600 Mutation Test and the cobas EGFR Mutation Test. More information about the cobas® HPV Test is available at www.hpv16and18.com.
About Human Papillomavirus and Cervical Cancer
Persistent infection with Human Papillomavirus (HPV) 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 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 there are more than 500,000 new cases of cervical cancer annually.
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, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. 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 or www.usdiagnostics.roche.com.
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