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Health Canada Approves Hologic's HPV Genotype Assay for Use on Panther

NEW YORK (GenomeWeb News) – Canadian regulators have approved Hologic's Aptima HPV 16 18/45 genotype assay for the Panther system, the company said today.

Health Canada approved the Aptima HPV assay for the Panther system in November.

The genotype assay is performed using Hologic's ThinPrep liquid cytology system.

Health Canada approved the genotype assay for women at least 21 years of age with atypical squamous cells of undetermined significance cervical cytology results. For them, the assay can be used on samples that have tested positive with the Aptima HPV assay to evaluate the presence or absence of high risk HPV genotypes 16, 18, and/or 45.

Also, the genotype test can be used in women at least 30 years of age to test samples that have tested positive with the Aptima HPV assay. The Aptima HPV 16 18/45 genotype assay is to be used in combination with cervical cytology to evaluate the presence or absence of HPV types 16, 18, and/or 45.

Today's announcement follows US Food and Drug Administration approval of the assay on Hologic's Tigris platform in October 2012 and on Panther this past November. The assay was CE marked in December 2011.

According to Hologic, cervical cancer incidence rates have declined during the past four decades, but data indicates that adenocarcinoma cases have increased 32 percent in the same time period. Detecting HPV types 16 18/45 as part of reflex testing may result in the identification of up to 94 percent of all cervical adenocarcinomas by physicians, the company said.

Additionally, though HPV type 45 is identified in only .4 percent of women with normal cytology, data suggests it is the third most common HPV genotype in invasive cancer. "The addition of HPV genotype 45 is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates," Hologic said.