US-based Hologic has announced that the Health Canada has approved the Aptima HPV 16 18/45 genotype assay for use on the company's fully automated Panther system.
Hologic’s Aptima HPV 16 18/45 genotype assay is the only approved test for genotyping human papillomavirus (HPV) types 16, 18 and/or 45 in Canada.
Hologic Group senior vice president and diagnostics general manager Dr Rohan Hastie noted the company’s ability to add the Aptima HPV 16 18/45 genotype assay to the Panther menu further extends the capability of low- to high-volume laboratories throughout Canada to run multiple tests from a single specimen.
"Created to be a ‘sample-in-result-out’ random access instrument, Panther is designed to eliminate batch processing and automate virtually all aspects of nucleic acid testing on a single, integrated platform," Dr Hastie added.
The Aptima HPV 16 18/45 genotype assay is performed using Hologic’s ThinPrep liquid cytology platform and is intended to test specimens from women with Aptima HPV assay positive results. Health Canada has approved the test for two uses:
– In patients 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.
– In patients 30 years and older, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
The Aptima HPV 16 18/45 genotype assay was CE marked in December 2011 and received the US Food and Drug Administration approval on Hologic’s high-throughput Tigris system in October 2012 and its fully automated Panther system in November 2013.