What HPV genotyping tests are currently available?
The Cervista ®16/18 test is the only FDA approved HPV test currently available to determine the presence or absence of HPV types 16 and/or 18. The Cervista®HPV 16/18 test was approved by the FDA in 2009. As a result, of this approval, the American Society for Colposcopy and Cervical Pathology (ASCCP) issued guidelines that would allow women age thirty and older who are infected with a high-risk HPV while having a normal pap test to be genotyped with the Cervista HPV 16/18 test. Those women who were not positive for either type 16 or type 18 could avoid additional treatment and return to routine screening; while those found positive for either type may be referred to colposcopy for further evaluation.
