New HPV test to identify virus variants

Physicians believe the test will further stratify women at high risk for developing cervical cancer, although plans for its use need to be refined.

By Victoria Stagg Elliott — Posted April 7, 2009

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The Food and Drug Administration on March 13 sanctioned for the first time an assay to determine if a human papillomavirus infection is caused by the variants most likely to lead to cancer of the cervix.

Cervista HPV 16/18 is a test manufactured by Hologic Inc., a women's health company. The test detects in cervical cells the DNA sequences of viral number 16 and 18. These types cause approximately 70% of cervical cancers.

"[This test] will fine-tune the current method of evaluating women with HPV," said Michael Gold, MD, associate professor and director of the gynecologic oncology division at Vanderbilt University Medical Center in Tennessee. "It will identify a subgroup of women most likely to develop cervical cancer and reassure the others."

The agency also gave the nod to the Cervista HPV HR test, also made by Hologic. This test is the second to identify multiple risky strains of this virus, although it doesn't specify the type. Like the HPV test manufactured by Qiagen, it is approved for use in females with borderline cytology results, or any woman older than 30 in conjunction with a Pap smear. The HPV 16/18 test can be added when those results are positive.

"Results from these two tests -- when considered with a physician's assessment of the patient's history, other risk factors, and professional guidelines -- can help physicians better determine risk and could lead to better patient management," said Daniel G. Schultz, MD, director of the FDA's Center for Devices and Radiological Health.

Public health agencies and medical societies are expected to gather within the year to develop guidelines on incorporating these new tests into cervical cancer screening.

Figuring out how HPV testing fits in has long been controversial because of concerns regarding the cost of the test itself, follow-up care or any associated counseling. The U.S. Preventive Services Task Force says evidence is insufficient to recommend either for or against routine HPV testing, although it is increasingly a part of gynecological care and evidence is emerging that the associated worries may be unfounded.

A study in the March Obstetrics & Gynecology documented the experience of Kaiser Permanente in California. This large HMO performed 812,598 routine HPV tests on 580,289 women over a five-year period but did not find an excessive rate of positive results.

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