Two Roche HPV diagnostic tests to receive FDA review

Roche on Tuesday announced that FDA will review applications for the company's two human papillomavirus diagnostic tests, the Baltimore Sun reports (Bishop, Baltimore Sun, 3/7).

Roche's Amplicor HPV test is designed to accurately detect 13 of the more common high-risk HPV strains in standard clinical trials, AFX/Forbes reports.

The other test, called the Linear Array HPV Genotyping test, is designed to identify which of the 13 high-risk HPV strains are in a sample.

According to AFX/Forbes, persistent infection with HPV is a leading cause of cervical cancer (AFX/Forbes, 3/6).

"DNA tests that are currently used in conjunction with Pap smear tests for cervical cancer screening can only tell if a woman has HPV infection but cannot identify which type she has," Daniel O'Day, head of Roche Molecular Diagnostics, said, adding, "We believe availability of both tests could offer important, clinically relevant information to clinicians working to better identify and manage persistent, high-risk HPV infections before they progress to more serious forms of disease" (Reuters, 3/6).

Digene's DNA Pap test -- which combines the traditional Pap test with a DNA test for 13 strains of HPV -- received FDA approval in March 2003 as a primary screening tool for cervical cancer for women ages 30 and older.

Digene's test is 99% accurate at identifying changes in cervical cells, compared with an 80% accuracy rate for the Pap test (Kaiser Daily Women's Health Policy Report, 1/23).

According to the Sun, other businesses and researchers, including California-based Gen-Probe and Wisconsin-based Third Wave Technologies, are developing HPV-related screening devices.

Digene has sued Third Wave for patent infringement, and Third Wave countersued alleging that Digene is using "its monopoly power to thwart competition" (Baltimore Sun, 3/7).