New HPV test gains approval from FDA

Add another human papillomavirus (HPV) test to the clinical arsenal. The Food and Drug Administration (FDA) has approved the Roche cobas HPV Test. The new test individually identifies genotypes 16 and 18, the two highest-risk HPV genotypes responsible for more than 70% of cervical cancer cases, while simultaneously detecting 12 other high-risk HPV genotypes.

The cobas HPV test received FDA approval on April 19 and became commercially available on May 2, says Michael Weist, spokesperson for the Basel, Switzerland-based company. The test relies on amplification of target DNA by polymerase chain reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the other high-risk types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.

How will its cost compare with comparable HPV tests? "The cost for patients will be similar to what they pay now for HPV testing, which is comparable to the cost of a Pap test, but the value of the cobas HPV test will be much greater because physicians will get more information and get it faster," says Weist. "Because the test could mean fewer return visits, less re-testing, and earlier identification of women at risk, it could have a significant impact on reducing healthcare costs overall."

When should it be used?

Test results may be used in women age 30 and over, or women age 21 and older with borderline cytology results to determine the need for additional follow-up and diagnostic procedures. Test results should be used with a provider's assessment of cytology history, other risk factors, and professional guidelines, according to material from the FDA.

When should it not be used? The cobas HPV Test is not intended for use as a screening device for women under age 30 with normal cervical cytology, to substitute for regular cervical cytology screening, or for use in determining the need for treatment of the cervix in the absence of high-grade cervical dysplasia.

Data from the Addressing The Need for Advanced HPV Diagnostics (ATHENA) study, which involved more than 47,000 women in the United States, indicates that one in 10 women age 30 and older who tested positive for HPV 16 and/or 18 by the cobas HPV Test actually had cervical pre-cancer, even though they showed normal results with the Pap test.1

Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles sees a narrow band for use of the test. It might be helpful if a patient over age 30 is HPV-positive with a normal Pap smear, Nelson notes.

Other tests available

The Roche tests join other HPV tests on the U.S. market. The digene HC2 HPV Test from Hilden, Germany-based Qiagen NV emerged in 2003 as the first molecular diagnostics test to receive FDA approval. It is used to determine the need for colposcopy/biopsy referral for women with borderline abnormal cytology results and for co-testing with cytology to screen women age 30 and over to assess risk of cervical cancer caused by persistent unresolved HPV infection.

In 2009, the FDA approved two tests from Bedford, MA-based Hologic. The Cervista HPV HR test was approved for screening patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy, and as an adjunct with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.

The second test, the Cervista HPV 16/18 test, was approved for use in women age 30 and older as an adjunctive test with the Cervista HPV HR test in combination with cervical cytology to assess the presence or absence of specific high-risk HPV types. It also was approved as an adjunctive test with the Cervista HPV HR test in patients with ASC-US cervical cytology results, to assess the presence or absence of specific high-risk HPV types. The results of this test are not intended to prevent women from proceeding to colposcopy.


  1. Wright TC. Dawn of a new era: Targeted screening for patients with hidden disease. Presented at the 26th International Papillomavirus Conference. Montréal, Canada. July 2010.