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Dx Focus: FDA Approves Hologic's Aptima HPV Genotyping Assay


Hologic said today that the US Food and Drug Administration has approved the Aptima HPV 16 18/45 genotype assay for use on the Panther automated molecular testing system.

The Aptima HPV 16 18/45 genotype assay is performed using Hologic's ThinPrep liquid cytology specimen and is intended to be tested from the same sample that has already received positive results from the Aptima HPV assay, which was approved by the US Food and Drug Administration in July for use on Panther (PCR Insider 7/25/13).

Hologic said it is the first test approved by the FDA for genotyping human papillomavirus types 16, 18, and/or 45. Recent data suggests that although cervical cancer incidence has decreased since the 1970s, the prevalence of adenocarcinoma cases has risen approximately 32 percent. Detection of these HPV types as part of reflex testing may help clinicians identify up to 94 percent of all cervical adenocarcinomas, Hologic said.

Although HPV genotype 45 is fairly uncommon, identified in only 0.4 percent of women with normal cytology, data indicates that it is the third most common HPV genotype in invasive cancer. The addition of HPV genotype 45 is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates, Hologic said. Studies have also shown that HPV types 16, 18, and 45 are more likely to be integrated into the human genome than are the other HPV types, and tumors with these genotypes may present earlier.

The FDA has approved the test for two uses: in patients 21 years and older with atypical squamous cells of undetermined significance cervical cytology results; and in patients 30 years and older with Aptima HPV assay positive results.

The assay was CE marked in December 2011 and received FDA approval on the Hologic high-throughput Tigris system in October 2012.