Hologic Announces FDA Approval of APTIMA HPV 16 18/45 Genotype Assay

Hologic

today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's APTIMA HPV 16 18/45 Genotype Assay for use on its TIGRIS instrument system. Hologic's APTIMA HPV 16 18/45 Genotype Assay is the first test FDA-approved for genotyping human papillomavirus (HPV) types 16, 18 and/or 45, which are associated with approximately 80% of all invasive cervical cancers worldwide. Detecting these HPV types provides health care professionals with more information regarding a patient's risk of subsequently developing cervical cancer. 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: Adjunctively with the APTIMA HPV Assay in women 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 Adjunctively with the APTIMA HPV Assay in women 21 years or older with atypical squamous cells