New Approval for HPV Test

Can now be used as stand-alone screening tool for cervical cancer

In April 2014, the US Food and Drug Administration (FDA) approved the cobas human papillomavirus (HPV) test as a stand-alone screening tool for primary cervical cancer in women age 25 and older. The test, developed by Roche Molecular Systems, Inc., was previously approved by the FDA in 2011 in tandem with cell biopsy or as a follow-up if abnormal cells were identified.

HPV causes common warts on the skin and sexually transmitted infections, spread during sex. Most HPVs are considered low risk and disappear after a couple of years. High-risk HPVs, on the other hand, cause cervical cancer in 10% of women with persistent infections.

The new test identifies 14 HPV genotypes, including genotypes 16 and 18, which cause 70% of cervical cancers.

For more information, visit: fda.gov and cancer.gov.