The FDA approves Roche's (RHHBY -0.2%) cobas HPV molecular diagnostic assay for use as a stand-alone screening test for HPV. Previously, the product was cleared only for use in conjunction with or as a follow-on diagnostic to a PAP test for women at least 30 years old.
The test detects HPV types 16 and 18 which are responsible for 70% of cervical cancer. It detects 12 other high risk types in a pooled result.
The clinical trial also showed that utilizing the automated cobas HPV test as a first-line diagnostic and then reflexing to a cervical cytology (PAP) test would enable clinicians to detect more disease and eliminate unnecessary follow-up procedures.