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Canada Approves Roche's HPV Test as a First-line Cervical Cancer Screen

NEW YORK (GenomeWeb) – Roche announced after the close of the market on Tuesday that Health Canada approved the cobas 4800 HPV Test as a first-line primary screening test for cervical cancer in women at least 25 years old.

The announcement follows similar approval of the test by the US Food and Drug Administration in April.

The test provides pooled high-risk HPV DNA results and individual detection of HPV 16 and 18, which together are responsible for about 70 percent of cervical cancer, Roche said. Health Canada's approval was based on the Athena trial of more than 47,000 women, which demonstrated that about 25 percent of women who are HPV 16 positive will have cervical cancer within three years. The study also found that almost one in seven women with normal Pap cytology who were HPV 16 positive had high-grade cervical disease that was missed by cytology.

The Athena trial found that using the Roche test to identify women testing positive for HPV 16 or 18 and using cervical cytology as a triage, follow-up test would provide clinicians improved detection without the referral of a "significant number" of women for unnecessary follow-up.

In addition to detecting HPV 16 and 18, Roche's test reports on 12 other high-risk HPV types and runs on Roche's cobas 4800 platform, an automated molecular diagnostic system that runs PCR-based assays.

The cobas HPV test was initially approved by the FDA in 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 older to assess the presence or absence of high-risk HPV genotypes.