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FDA Approves Aptima HPV 16 18/45 Genotype Assay for Use on Hologic's Panther System
Date:11/7/2013

BEDFORD, Mass., Nov. 7, 2013 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, announced today that the U.S. Food and Drug Administration (FDA) has approved the Aptima HPV 16 18/45 genotype assay for use on the Company's fully automated Panther 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 Aptima HPV assay positive results.

Hologic's Aptima HPV 16 18/45 genotype assay is the first test FDA‐approved for genotyping human papillomavirus (HPV) 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 in the same time frame.1 Detection of these HPV types as part of reflex testing may help clinicians identify up to 94 percent of all cervical adenocarcinomas.2

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. Studies have 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.2

"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 tes
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SOURCE Hologic, Inc.
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