The FDA has approved Gen-Probe’s Aptima HPV assay, an amplified nucleic acid test that detects 14 high-risk strains of human papillomavirus (HPV) that are associated with cervical cancer and precancerous lesions. The Aptima HPV assay is approved to test women ≥21 years of age whose Pap tests showed atypical squamous cells of undetermined significance (ASC-US). Testing is performed from ThinPrep liquid cytology specimens routinely used for Pap testing.  Aptima HPV is approved to run on Gen-Probe’s TIGRIS instrument system.

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