FDA Approves Cobas HPV Test

HPV Infected Cells — (Photo : Flickr: Ed Uthman) In a Pap smear: Healthy cells are on the left. Cells infected with the human paillomavirus are on the right.

The United States Food and Drug Administration approved the first-ever DNA-based HPV test for women 25 years old and older as a primary diagnostic tool for cervical cancer screenings.

The U.S. Food and Drug Administration (FDA) announced their approval of the DNA screening -- called the Cobas HPV test -- eleven days after French drug company Roche first announced the FDA Advisory Committee's unanimous recommendation that the test should be approved for primary use.

According to the FDA, the Cobas HPV test is the first federally approved genetic sequencing test that can be used as an alternative to the decades-old pap-smear test that is most commonly used by physicians to screen for the human papillomavirus (HPV) and primary cervical cancer.

The test, developed by Roche Molecular Systems, can reportedly detect up to 14 different types of HPV that commonly lead to a high risk of cervical cancer. According to the FDA, it was most important that it was established that the test could accurately detect HPV 16 and HPV 18, two of the most common forms of HPV that cause an estimated 70 percent of all cervical cancer cases.

The Advisory Committee approval and eventual FDA approval occurred after close examination of data from a number of clinical trials. According to the FDA, the cobas HPV Test was deemed an effective primary screening tool for cervical cancer after a study of more than 40,000 women 25 years and older showed that the cobas HPV test is not only as safe as a traditional Pap-smear test, but notably more effective at detecting some forms of HPV compared to traditional testing, which can more easily influenced by ill luck and human error.

This is not the first time the cobas HPV Test has found approval, as it was previously approved as only a co-test with a traditional Pap test. Still, with proven effectiveness, accuracy, safety, the test can now be used exclusively by physicians who have access to genetic sequencing equipment.

The FDA announced this approval in a press release on April 24.