Roche, a Switzerland-based firm has obtained the US Food and Drug Administration (FDA) clearance for its cobas HPV (Human Papillomavirus) test for first-line primary screening test of cervical cancer in women 25 and older. HPV causes nearly all cases of cervical cancer.
The test can be used alone to help a health care professional to assess the need for a woman to undergo additional diagnostic testing for cervical cancer and also provides the information about the patient’s risk for developing cervical cancer in the future.
The cobas HPV Test provides both high-risk HPV DNA results and individual detection of HPV 16 and HPV 18, which are responsible for about 70% of cervical cancer.
Following the 12 March unanimous recommendation from the Microbiology Devices Panel of the FDA’s Medical Devices Advisory Committee, the approval makes the cobas HPV test the first and only HPV test in the US approved for first-line primary screening.
Earlier, the FDA approved cobas HPV Test for use as a follow-up test for Pap (Papanicolaou) results and as an adjunct to Pap in women 30 years and older.
The FDA’s decision to approve the expanded use for the cobas HPV Test was based on results from the landmark ATHENA trial, which enrolled more than 47,000 women.
The trial demonstrated that one in four women who are HPV 16 positive will have cervical disease within three years and that nearly one in seven women with normal Pap cytology who were HPV 16 positive actually had high-grade cervical disease that was missed by cytology.
Additionally, the results from the trial included a comparison of a cobas HPV Test screening strategy to alternative strategies using Pap cytology and HPV testing.
According to Roche, the cobas HPV test is able to screen for a variety of high-risk strains of HPV.
The system also runs the cobas CT/NG test (chlamydia/gonorrhea), the cobas BRAF V600 mutation test and the cobas EGFR mutation test.