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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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