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

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Hologic, Inc. announced today that Health Canada has granted medical device licenses for Hologic's APTIMA HPV and APTIMA HPV 16 18/45 genotype assays. Both assays are in vitro nucleic acid amplification tests (NAATs) that are designed to detect high-risk strains of the human papillomavirus (HPV) that are associated with cervical cancer and precancerous lesions. HPV is among the most common sexually-transmitted infections (STIs) in Canada and worldwide. The tests have been approved to run on Hologic's fully automated, high-throughput TIGRIS instrument system.

The APTIMA HPV assay is designed to detect 14 high-risk HPV types associated with cervical cancer and precancerous lesions. The APTIMA HPV 16 18/45 genotype assay is approved for genotyping HPV types 16, 18 and/or 45, which are associated with approximately 80% of all invasive cervical cancers worldwide. Detecting the specific HPV types 16, 18 and/or 45 provides healthcare professionals with additional information regarding a patient's risk of subsequently developing cervical cancer. Both assays can be performed using Hologic's ThinPrep liquid cytology specimens collected for routine pap tests as well as Hologic's APTIMA cervical specimen collection and transport kit.

"Most HPV infections clear up on their own, so it's important to identify those persistent, high-risk infections that are most likely to lead to cervical cancer," said Tom Wright, MD, Professor of Pathology and Cell Biology at the Columbia University Medical Center. "In numerous clinical studies involving approximately 45,000 women, the APTIMA HPV assay has consistently shown similar sensitivity and better specificity than the most frequently used DNA-based test. This means the APTIMA HPV assay is highly accurate in detecting cervical disease, but is less likely to raise false alarms that can result in unnecessary medical procedures."

Health Canada's approval of the APTIMA HPV and HPV 16 18/45 genotype assays is based on data from the CLEAR (Clinical Evaluation of APTIMA HPV RNA) trial, which analyzed approximately 11,000 women undergoing routine Pap testing at 18 US clinics. In the study, the APTIMA HPV assay showed similar sensitivity for the 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 the DNA-based test, and this advantage was statistically significant.

About the Hologic APTIMA HPV and APTIMA HPV 16 18/45 Genotype Assays

The 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 from women 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.

 

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