Switzerland-based Roche has obtained US Food and Drug Administration (FDA) clearance for its cobas HPV (Human Papillomavirus) test as a first-line primary screening for 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 assess the need for a woman to undergo additional diagnostic testing for cervical cancer and also provides information about the patient’s future risk for developing the disease.
The cobas HPV test provides both high-risk HPV DNA results and individual detection of HPV 16 and HPV 18, which are responsible for around 70% of cervical cancer.
Following the 12 March unanimous recommendation from the FDA’s medical devices advisory committee microbiology devices panel, the latest FDA approval makes the cobas HPV test the first and only HPV test in the US approved for first-line primary screening.
The FDA previously approved cobas HPV Test for use as a follow-up test for papanicolaou results and as an adjunct to Pap in women 30 years and older.
However, this approval expands the use of the test to include use as either a co-test or as a primary cervical cancer screening test.
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.
In addition, results from the trial included a comparison of a cobas HPV Test screening strategy to alternative strategies using Pap cytology and HPV testing.
Roche diagnostic division COO Roland Diggelmann said the company is very pleased that the FDA has approved this test for first-line use in cervical cancer screening.
"It is a recognition for the value the cobas HPV test provides to physicians and women to make more informed decisions that can ultimately prevent cervical cancer development," Diggelmann said.
"We are committed to working with the medical community and professional organisations to put the necessary clinical practice guidelines in place to encourage providers to incorporate this new screening strategy alternative in their patient protocols."
According to Roche, the cobas HPV test is able to screen for a variety of high-risk strains of HPV.
The cobas HPV test is the only FDA-approved HPV assay that simultaneously provides pooled results of 12 known high-risk genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18, giving three results in just one test.
The system also runs the cobas CT/NG test (chlamydia/gonorrhea), the cobas BRAF V600 mutation test and the cobas EGFR mutation test.
Image: High-grade dysplasia (carcinoma in situ) in the uterine cervix. Photo: courtesy of Haymanj.