FDA Approves Aptima HPV 16 18/45 Genotype Assay for Use on Hologic's Panther System

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 tests from a single specimen, on a cost-effective, highly flexible and fully automated molecular testing platform," said Rohan Hastie, Ph.D., Hologic's Group Vice President – Diagnostics.

The Aptima HPV 16 18/45 genotype assay is intended to test specimens from women with Aptima HPV assay positive results.  The FDA has approved the test for two uses:

1. In patients 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.
2. In patients 30 years and older, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

The Aptima HPV 16 18/45 genotype assay was CE marked in December 2011 and received FDA approval on the Hologic high-throughput Tigris system in October 2012.

For more information about Hologic's molecular diagnostic technology, please visit www.hologic.com or www.gen-probe.com.

About Hologic, Inc.:

Hologic, Inc. is 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. The Company operates four core business units focused on breast health, diagnostics, GYN surgical and skeletal health. With a comprehensive suite of technologies and a robust research and development program, Hologic is committed to improving lives. The Company is headquartered in Massachusetts.

Hologic, Aptima, Panther, ThinPrep, Tigris and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.

Forward-Looking Statement Disclaimer:

This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic's Aptima assays, and its Panther system. There can be no assurance the assays and system will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the systems can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based.

1. Saslow D, et al. J Low Genit Tract Dis 2012;16(3):175-204.
2. de Sanjose S, et al. Lancet Oncol 2010; 11(11): 1045-56.

SOURCE Hologic, Inc.