DNA-Based Test for HPV Types 16, 18 Approved


A test that detects the genotypes of human papilloma virus (HPV) 16 and 18, which cause the majority of cervical cancer cases, was recently approved by the Food and Drug Administration.

The test, which will be marketed as the Cervista HPV 16/18 test, is the first DNA-based test for these HPV types, according to a written statement issued by the FDA. HPV types 16 and 18 cause of about 70% of cervical cancers.

The FDA also approved the Cervista HPV HR test, another DNA-based test, which detects “essentially all of the high-risk HPV types in cervical cell samples.”

Both tests, which are manufactured by Hologic Inc., can be combined with cytology to assess the risk of cervical disease in women aged 30 years and older, with borderline cytology results, according to the agency statement.

“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,” Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in the statement.

The Cervista HPV HR test was approved specifically for screening cervical cytology results with atypical squamous cells of undetermined significance to determine the need for referral to colposcopy, according to a statement issued by Hologic.

The company adds that the results of the Cervista HPV 16/18 test “are not intended to prevent women from proceeding to colposcopy.”

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