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FDA Approves Gen-Probe's APTIMA® HPV Assay, New Molecular Test to Detect Virus that Causes Cervical Cancer

Gen-Probe, a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility, has announced that the US Food and Drug Administration (FDA) has approved its APTIMA HPV assay, an amplified nucleic acid test that detects high-risk strains of human papillomavirus (HPV) that are associated with cervical cancer and precancerous lesions. The test has been approved to run on Gen-Probe's fully automated, high-throughput TIGRIS instrument system.

Gen-Probe's TIGRIS system is the first fully automated, high-throughput molecular testing system, and the only one approved for use with an HPV test. More than 200 TIGRIS systems are being used by US clinical laboratories. The system has been cleared by the FDA to test for: Chlamydia and gonorrhea, two common bacterial sexually transmitted diseases (STDs), with the APTIMA Combo 2, APTIMA CT and APTIMA GC assays; Trichomonas vaginalis, the cause of a common parasitic STD, with the APTIMA Trichomonas assay; Human papillomavirus, with the APTIMA HPV assay.

"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," said Carl Hull, Gen-Probe's president and chief executive officer. "FDA approval represents a major milestone for the Company, since developing the APTIMA HPV assay was the largest and most complex diagnostic R&D programme we have ever completed."

The APTIMA HPV assay detects 14 high-risk HPV types associated with cervical cancer and precancerous lesions. Testing is performed from ThinPrep liquid cytology specimens routinely used for Pap testing. Unlike other FDA-approved, DNA-based HPV tests, the APTIMA HPV assay detects messenger RNA over-expressed from two viral oncogenes that are integral to the development of cervical cancer.

"Most HPV infections clear up on their own, so it's important to identify those persistent, high-risk infections that are most likely to lead to cervical cancer," said Tom Wright, MD, professor of pathology and cell biology at the Columbia University Medical Center. "In numerous clinical studies involving approximately 45,000 women, the APTIMA HPV assay has consistently shown similar sensitivity and better specificity than the most frequently used DNA-based test. This means the APTIMA HPV assay is highly accurate in detecting cervical disease, but is less likely to raise false alarms that can result in unnecessary medical procedures."

The APTIMA HPV assay is approved to test women age 21 and older whose Pap tests showed atypical squamous cells of undetermined significance (ASC-US), meaning they were neither normal nor clearly indicative of pre-cancerous changes, and to screen women age 30 and older as an adjunct to Pap testing. This means the assay can be used to meet consensus guidelines for cervical cancer screening recommended by leading US medical organizations. "Physicians can use the APTIMA HPV test to make early, more accurate decisions about patient care, which in turn may prevent many women from developing a potentially deadly disease," Dr. Wright said.

FDA approval was based on data from the CLEAR (CLinical Evaluation of APTIMA HPV RNA) trial, which analyzed approximately 11,000 women undergoing routine Pap testing at 18 US clinics. In the study, the APTIMA HPV assay showed similar sensitivity for the detection of cervical disease as an FDA-approved, DNA-based test. However, the specificity of the APTIMA HPV assay was higher than that of the DNA-based test, and this advantage was statistically significant.


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