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Canada Approves Hologic Aptima Assays for HPV

NEW YORK (GenomeWeb News) – Hologic said on Thursday that Canadian regulators approved two of the company's assays for the detection of high-risk strains of human papillomavirus.

Health Canada granted medical device licenses to Hologic's Aptima HPV and Aptima HPV 16 18/45 genotype assays. Both assays are in vitro nucleic acid amplification tests for detecting HPV strains that are associated with cervical cancer and precancerous lesions, Hologic said. The assays were approved to run on the company's Tigris instrument.

The US Food and Drug Administration approved the Aptima HPV Assay in 2011 and the Aptima HPV 16 18/45 Assay last fall. Both assays were developed by Gen-Probe, which Hologic acquired during the summer.

The Aptima HPV Assay detects 14 high-risk HPV types and was approved by Health Canada for two uses — the screening of patients with atypical squamous cells of undetermined significance cervical cytology results to determine whether patients should be referred to colposcopy; and for use adjunctively with cervical cytology to screen women at least 30 years old to evaluate the presence or absence of high-risk HPV types.

The Aptima 16 18/45 Assay is for use in women who have tested positive with the Aptima HPV Assay, and it was approved by Health Canada as an adjunct test with the Aptima HPV Assay in women at least 30 years old and in combination with cervical cytology to assess the presence or absence of HPV genotypes 16, 18, and/or 45.

It also received approval as an adjunct test to be used with the Aptima HPV Assay for women at least 21 years old with atypical squamous cells of undetermined significance cervical cytology results for evaluating the presence or absence of HPV genotypes 16, 18 and/or 45.

Results from the Aptima 16 18/45 Assay are not intended to prevent women from proceeding to colposcopy, Hologic noted.

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