The FDA has approved the cobas HPV Test, the first one-pass
screening tool to identify the two HPV strains that cause 70
percent of cervical cancers. Current tests can detect more than
a dozen types of HPV linked to cancer, but the cobas also
reveals whether a woman specifically has HPV-16 or HPV-18.
Approval was based on the ATHENA study of more than 47,000
women. Researchers found that one in 10 women age 30 and older,
who tested positive for HPV 16 and/or 18 by the cobas HPV Test,
actually had cervical pre-cancer even though they showed normal
results with the Pap test. The cobas test detects precancerous
cells over 90 percent of the time, but about 30 percent of women
who test positive for the most dangerous HPV strands turn out
not to have precancerous lesions. Still, experts believe the
test will help doctors make earlier, more accurate diagnoses,
preventing many woman from developing cervical cancer and
improving the care of those who have already developed the
disease.