NEW YORK (GenomeWeb News) – Health Canada has approved Hologic's Aptima HPV assay for use on the Panther system, the company said on Thursday.
The test is performed with Hologic's ThinPrep liquid cytology specimen and can be used before or after it has been processed for cytology testing on the ThinPrep 2000 system. The mRNA-based assay is a nucleic acid amplified test for detecting 14 high-risk strains of human papillomavirus associated with cervical cancer and precancerous lesions.
According to Hologic, the test has demonstrated "significantly improved specificity with no compromise in disease detection."
The Aptima HPV assay is for the detection of mRNA overexpressed from the E6 and E7 viral oncogenes in 14 high-risk HPV types and was approved for two uses. One is the screening of women at least 21 years of age with atypical squamous cells of undetermined significance cervical cytology results for determining whether a patient should be referred to colposcopy.
It also was approved for use as an adjunct with cervical cytology to screen women at least 30 years of age to evaluate for the presence or absence of high-risk HPV types.
The US Food and Drug Administration approved the test for Panther in July. Canada approved the test for use on Hologic's Tigris platform in April.