Hologic Inc, Bedford, Mass, reports that the FDA has approved its APTIMA HPV 16 18/45 Genotype Assay for use on its TIGRIS instrument system.

The 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, according to the company. 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 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.

Hologic acquired the APTIMA HPV 16 18/45 Genotype Assay as part of its acquisition of Gen-Probe Inc, which was completed on August 1.

This assay is performed from Hologic’s ThinPrep liquid cytology specimens, which are routinely collected for pap testing.

The company expects to begin marketing the assay during the first quarter of fiscal 2013.

[Source: Hologic]