FDA has cleared Roche’s cobas HPV test for identifying women at high risk of developing cervical cancer. The firm claims clearance means the previously CE-marked assay is now the only FDA-approved test that allows HPV 16 and HPV 18 genotyping at the same time as testing for 12 other high-risk HPV genotypes.
Approval of cobas HPV was based on data from the Athena study in over 47,000 U.S. women. The trial showed that 1 in 10 women aged 30 years or more who tested positive for HPV 16 and/or 18 actually had cervical precancer, even though their Pap test results were normal.
HPV infection is implicated in over 99% of cervical cancers worldwide, Roche notes. NCI figures suggest there are 12,200 new cases of the disease in the U.S. every year, and 4,210 cervical cancer-related deaths. WHO estimates suggest there are over 470,000 new cases of cervical cancer worldwide annually.