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FDA Approves Hologic's HPV Genotype Assay for Panther

NEW YORK (GenomeWeb News) – Hologic said after the close of the market on Thursday that the US Food and Drug Administration has approved the Aptima HPV 16 18/45 genotype assay for use on the Panther system.

The assay is performed using Hologic's ThinPrep liquid cytology specimen and is intended for use with a sample that already has received positive results with the Aptima HPV assay, the company said. The assay received CE marking in 2011 and was FDA approved for use on Hologic's Tigris platform in October 2012.

Hologic said the assay is the first FDA-approved test for genotyping human papillomavirus types 16, 18, and/or 45.

While cervical cancer incidence rates have declined since the 1970s, data suggests that adenocarcinoma cases have increased 32 percent during the same time frame, according to the company. Detecting HPV types 16 18/ 45 as part of reflex testing could help physicians identify up to 94 percent of all cervical adenocarcinomas, it added.

HPV type 45 is identified in only .4 percent of women with normal cytology, but data indicates it is the third most common HPV genotype in invasive cancer. The addition of HPV type 45 "is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates," Hologic said.

It further said that HPV types 16 18/45 are more likely to be integrated into the human genome, compared with other HPV types, and tumors with these genotypes may present earlier.

"The addition of the Aptima HPV 16 18/45 genotype assay to the Panther menu further extends the capability of low- to high-volume laboratories to run multiple tests from a single specimen, on a cost-effective, highly flexible and fully automated molecular testing platform," Rohan Hastie, Hologic's group vice president for diagnostics, said in a statement.

FDA approved the assay on Panther for two uses. One is for patients at least 21 years old with atypical squamous cells of undetermined significance cervical cytology results. In this group the assay can be used to evaluate the presences of HPV types 16 18/45. Along with other information, such as a doctor's assessment of cytology history, other risk factors, and professional guidelines, results from the Aptima HPV 16 18/45 assay can be used to guide the management of patients.

The test is not intended as a deterrent against colposcopies, Hologic said.

The second FDA-approved use of the assay is for patients at least 30 years old. The assay results are to be used in combination with cervical cytology to evaluate the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. Physicians may use the information in combination with cytology history, other risk factors, and professional guidelines to guide patient management, Hologic said.