FDA Clears Gen-Probe’s mRNA-Based HPV Assay for Use Alongside Pap Tests

FDA approved Gen-Probe’s Aptima HPV assay for use on the firm’s automated Tigris instrument system. The amplified nucleic acid test is designed to detect 14 high-risk strains of HPV associated with cervical cancer and precancerous lesions, using ThinPrep liquid cytology specimens.

Approval covers use of the assay for testing women aged at least 21 years, whose Pap tests show atypical squamous cells of undetermined significance, and for screening women aged 30 years or more as an adjunct to Pap testing. Clinical data submitted to FDA for review included results from the Clear trial, which included some 11,000 women undergoing routine Pap testing. It showed that while the Aptima test showed similar sensitivity for detecting cervical disease as an approved DNA-based test, the Aptima HPV assay showed significantly higher specificity.

Gen-Probe says that unlike other FDA-approved, DNA-based HPV tests, the Aptima assay detects mRNA that is overexpressed from two viral oncogenes critical to the development of cervical cancer. "We believe our Aptima HPV assay will offer physicians and patients a more accurate screening test for cervical cancer and significantly improve testing efficiency for our laboratory customers,” comments Carl Hull, Gen-Probe president and CEO. "FDA approval represents a major milestone for the company, since developing the Aptima HPV assay was the largest and most complex diagnostic R&D program we have ever completed.”

Gen-Probe’s Tigris system is already FDA approved for use in testing for chlamydia and gonorrhea using the Aptima Combo2, Aptima CT, and Aptima GC assays as well as Trichomonas vaginalis testing using the Aptima Trichomonas assay. The firm says the Tigris system can process up to 1,000 patient samples a day and generate any combination of chlamydia/gonorrhea, trichomonas, or HPV test results.