APTIMA HPV 16 18/45 Genotype Assay Approved

Hologic announced that the FDA has approved the Aptima HPV 16 18/45 Genotype Assay for genotyping human papillomavirus (HPV) types 16, 18 and/or 45 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 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 with atypical squamous cells of undetermined significance (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.

The Aptima HPV 16 18/45 Genotype Assay is performed from Hologic's ThinPrep liquid cytology specimens, which are routinely collected for pap testing. 

The Company expects to begin commercialization of the Aptima HPV 16 18/45 Genotype Assay during the first quarter of fiscal 2013.

For more information visit www.hologic.com.