FDA approve Aptima HPV Assay (Hologic) for detecting Human Papillomavirus

The FDA has approved the Aptima HPV 16 18/45 Genotype Assay, from Hologic, for use on its Tigris instrument system. It is the first FDA-approved test for genotyping human papillomavirus (HPV) types 16, 18 and/or 45, which are associated with approximately 80% of all invasive Cervical Cancers worldwide. The test is specifically approved for use 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. It is also approved for use 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. The Company expects to begin commercialization of the APTIMA HPV 16 18/45 Genotype Assay during the first quarter of fiscal 2013.