Hologic's APTIMA HPV Assay and APTIMA HPV 16 18/45 Genotype Assay Receive Canadian Regulatory Approval

Hologic, Inc. announced today thatHealth Canada has granted medical device licenses for Hologic's APTIMA HPV andAPTIMA HPV 16 18/45 genotype assays. Both assays are in vitro nucleic acidamplification tests (NAATs) that are designed to detect high-risk strains ofthe human papillomavirus (HPV) that are associated with cervical cancer andprecancerous lesions. HPV is among the most common sexually-transmittedinfections (STIs) in Canada and worldwide. The tests have been approved to runon Hologic's fully automated, high-throughput TIGRIS instrument system.The APTIMA HPV assay is designed to detect 14 high-risk HPV types associatedwith cervical cancer and precancerous lesions. The APTIMA HPV 16 18/45genotype assay is approved for genotyping HPV types 16, 18 and/or 45, whichare associated with approximately 80% of all invasive cervical cancersworldwide. Detecting the specific HPV types 16, 18 and/or 45 provideshealthcare professionals with additional information regarding a patient'srisk of subsequently developing cervical cancer. Both assays can be performedusing Hologic's ThinPrep liquid cytology specimens collected for routine paptests as well as Hologic's APTIMA cervical specimen collection and transportkit."Most HPV infections clear up on their own, so it's important to identifythose persistent, high-risk infections that are most likely to lead tocervical cancer," said Tom Wright, MD, Professor of Pathology and Cell Biologyat the Columbia University Medical Center. "In numerous clinical studiesinvolving approximately 45,000 women, the APTIMA HPV assay has consistentlyshown similar sensitivity and better specificity than the most frequently usedDNA-based test. This means the APTIMA HPV assay is highly accurate indetecting cervical disease, but is less likely to raise false alarms that canresult in unnecessary medical procedures."Health Canada's approval of the APTIMA HPV and HPV 16 18/45 genotype assays isbased on data from the CLEAR (Clinical Evaluation of APTIMA HPV RNA) trial,which analyzed approximately 11,000 women undergoing routine Pap testing at 18US clinics. In the study, the APTIMA HPV assay showed similar sensitivity forthe detection of cervical disease as a Health Canada-approved, DNA-based test.However, the specificity of the APTIMA HPV assay was higher than that of theDNA-based test, and this advantage was statistically significant.About the Hologic APTIMA HPV and APTIMA HPV 16 18/45 Genotype AssaysThe Hologic APTIMA HPV assay has been approved for two uses: -- To screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results in order to determine the need for referral to colposcopy. -- To be used adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.The APTIMA HPV 16 18/45 genotype assay is intended to test specimens fromwomen with APTIMA HPV assay positive results and is approved for two uses: -- To be used adjunctively with the APTIMA HPV assay in women aged 30 years and older in combination with cervical cytology to assess the presence or absence of specific high?risk genotypes 16, 18 and/or 45. -- To be used adjunctively with the APTIMA HPV assay in women aged 21 years or older with ASC?US cervical cytology results to assess the presence or absence of specific high?risk HPV genotypes 16, 18 and/or 45. The results of this test are not intended to prevent women from proceeding to colposcopy.