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FDA Approves Roche HPV Assay as First-Line Cervical Cancer Screening Method

NEW YORK (GenomeWeb) — Roche said today that the US Food and Drug Administration has approved its cobas HPV test for use as a first-line primary screening test for cervical cancer in women ages 25 years and older.

The approval follows a unanimous recommendation issued last month by the Microbiology Devices Panel of the FDA's Medical Devices Advisory Committee, making Cobas HPV the first and only HPV test approved in the US for first-line primary cervical cancer screening.

Roche's test provides genotyping information for HPV 16 and 18, which are the highest-risk types responsible for about 70 percent of cervical cancer, while simultaneously reporting on the 12 other high-risk HPV types. It runs on Roche's cobas 4800 platform, an automated molecular diagnostic system that runs PCR-based assays.

The cobas HPV test was first approved by the FDA in April 2011 for screening patients age 21 and older with abnormal cervical cytology results, as well as for use adjunctively with normal cervical cytology in women ages 30 and over to assess the presence or absence of high-risk HPV genotypes.

"This is an outstanding example of how innovation in diagnostics is shifting the disease management paradigm to improve patient care and people's health," Roland Diggelmann, COO of Roche Diagnostics, said in a statement. "We are committed to working with the medical community and professional organizations to put the necessary clinical practice guidelines in place to encourage providers to incorporate this new screening strategy alternative in their patient protocols."

"Today's action by the FDA has given women a better alternative method to reassure themselves they do not have this deadly yet preventable disease," Mark Stoler, professor of pathology and clinical gynecology at the University of Virginia Health System, said in a statement. "Using the cobas HPV test as a primary screen means that women will have the opportunity to receive a better and more accurate standard of care. Clinically validated HPV screening detects the virus that causes cervical cancer and does a better job identifying women at risk than Pap testing alone. But most importantly, women found to be HPV negative are provided a greater sense of security that they are safe from the disease."

Some women's health advocacy groups earlier this month attempted to convince the FDA to not approve Roche's test, claiming that using it instead of the well-established Pap test could lead to higher medical costs, overtreatment, and confusion.

"It replaces a safe and effective well-established screening tool and regimen that has prevented cervical cancer successfully in the US with a new tool and regimen not proven to work in a large US population," the groups, which included the American Medical Women's Association and Our Bodies Ourselves, wrote in a letter to FDA Commissioner Margaret Hamburg.