Data Reinforce HPV as First-Line Test in Cervical Cancer Screening

Persistent HPV infection has been implicated in over 99% of CC cases worldwide. Roche Diagnostics Corporation, of the Roche group (Basel, Switzerland), has announced that 3-year end-of-study data from the ATHENA trial, now published in the journal Gynecologic Oncology (January, 2015), reinforces guidlines issued by the Society for Gynecologic Oncology (SGO) and the American Society for Colposcopy and Cervical Pathology (ASCCP) (developed with input from 5 additional medical organizations) to help clinicians effectively incorporate HPV testing into CC screening protocols. The newly issued interim clinical guidance (published simultaneously in Gynecologic Oncology, Journal of Lower Tract Genital Disease, and Obstetrics and Gynecology) supports HPV primary screening with an FDA-approved test in women 25 and older as an effective alternative to current screening recommendations with Pap smear alone or with Pap smear and HPV co-testing.

The ATHENA data helped inform the interim guidance report. Primary screening using Roche Diagnostics’ “cobas HPV Test” detected significantly more cervical disease than a Pap test alone. A woman with a negative cobas HPV result had less than half the risk of developing pre-CC within 3 years than a woman with a negative Pap result.

For the first time, guidance provides clinicians the option to screen women 25 and older with an HPV test, prior to 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 a third of all women with CIN3, the highest grade of pre-CC, were age 25–29. The ATHENA study also found that Pap testing performed poorly in this age group, as more than 50% of the CIN3, or worse disease, detected in women 25–29 by cobas HPV was not detected by a Pap test.

"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 CC," said Alan Wright, MD, MPH, chief medical officer at Roche Diagnostics, "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 CC and we look forward to working with other professional societies as they develop official guidelines."

Clinically validated by the ATHENA trial, cobas HPV is currently the only HPV test approved (April 2014) by the FDA for use as a first-line primary screening test for CC in women 25 and older. 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.

cobas HPV is performed on the cobas 4800 System, which offers walk-away automation of nucleic acid purification, PCR set-up, and real-time PCR amplification and detection to help laboratories achieve maximum efficiency.

Related Links:
Roche
cobas HPV Test
The cobas 4800 system