Diagnostic and medical imaging systems provider Hologic has received Health Canada approval for use of its Aptima HPV 16 18/45 genotype assay 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.
The genotype assay is performed using Hologic's ThinPrep liquid cytology system.
Health Canada approved the genotype assay for women at least 21 years old 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 45.
In addition, the genotype test can be used in women at least 30 years old 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.
Hologic diagnostics group senior vice-president and general manager Dr Rohan Hastie said 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 said.
According to the company, cervical cancer incidence rates have declined during the past four decades, but prevalence of adenocarcinoma cases has risen approximately 32% in the same time frame.
Detecting HPV types 16 18/45 as part of reflex testing may result in the identification of up to 94% of all cervical adenocarcinomas.
Although HPV genotype 45 is fairly uncommon, identified in only 0.4% of women with normal cytology, the data suggests it is the third most common HPV genotype associated with 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, the company reported.
Studies have shown that HPV types 16, 18 and 45 are more likely to be integrated into the human genome than are the other HPV types, and tumours with these genotypes may present earlier.
According to GlobalData estimates, the Canadian tumour markers market was valued at $18.8m in 2012 and is expected to grow at a CAGR of 5.6% to reach $27m by 2019.