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November 3, 2011

FDA clears new Gen-Probe HPV assay

The US Food and Drug Administration (FDA) has approved Gen-Probe's Aptima human papillomavirus (HPV) assay, used to diagnose cervical cancer.

The US Food and Drug Administration (FDA) has approved Gen-Probe’s Aptima human papillomavirus (HPV) assay, used to diagnose cervical cancer.

The Aptima HPV assay is an amplified nucleic acid test that detects 14 high-risk strains of HPV associated with cervical cancer and pre-cancerous lesions.

The test, approved to run on the company’s fully automated high-throughput TIGRIS instrument system, identifies messenger RNA over-expressed from two viral oncogenes that are responsible for cervical cancer.

The TIGRIS system can process up to 1,000 patient samples in a day, generating any combination of chlamydia, gonorrhoea, trichomonas or HPV test results.

The approval is backed by the data from the CLEAR trial, which demonstrated that Aptima HPV showed similar sensitivity for the detection of cervical disease as Pap testing.

Columbia University Medical Center pathology and cell biology professor Tom Wright said that the new HPV test could make early, accurate decisions about patient care, which may prevent from developing a potentially deadly disease.

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