BioCentury
ARTICLE | Clinical News

Aptima HPV 16 18/45 Genotype Assay regulatory update

October 22, 2012 7:00 AM UTC

Hologic said that FDA approved Aptima HPV 16 18/45 Genotype Assay for use on its Tigris instrument system to detect HPV genotypes 16, 18 and/or 45 in specimens that tested positive on Hologic's Aptima HPV Assay. Hologic plans to launch the assay in the U.S. this quarter. Aptima HPV 16 18/45 Genotype Assay is indicated as an adjunct to assess the presence or absence of genotypes 16, 18 and/or 45 in women ages >=30 years in combination with cervical cytology or in women >=21 years with atypical squamous cells of undetermined significance cervical cytology results. The company said the assay, which it gained through its August acquisition of Gen-Probe Inc., is the first FDA-approved genotyping test to detect HPV 16, 18 and/or 45 (see BioCentury, Aug. 6). ...