FDA Clears Hologic, Inc.'s HPV 16, 18/45 Genotype Assay

BEDFORD, Mass., Oct. 16, 2012 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s APTIMA HPV 16 18/45 Genotype Assay for use on its TIGRIS instrument system.

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, which are associated with approximately 80% of all invasive cervical cancers worldwide. Detecting these HPV types provides health care professionals with more information regarding a patient’s risk of subsequently developing cervical cancer.

The APTIMA HPV 16 18/45 Genotype Assay is intended to test specimens from women with APTIMA HPV Assay positive results and is approved for two uses:

• Adjunctively with the APTIMA HPV Assay in women 30 years and older in combination with cervical cytology to assess the presence or absence of specific high-risk genotypes 16, 18 and/or 45
• Adjunctively with the APTIMA HPV Assay in women 21 years or older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to assess the presence or absence of specific high-risk HPV genotypes 16, 18 and/or 45. The results of this test are not intended to prevent women from proceeding to colposcopy.

“The introduction of the APTIMA HPV 16 18/45 Genotype Assay enhances our HPV product offering on the TIGRIS platform,” said Rob Cascella, President and Chief Executive Officer of Hologic. “We are pleased to now offer the most comprehensive portfolio of products that address the cervical cancer screening market and we look forward to maintaining our leadership in this important field.”

Hologic acquired the APTIMA HPV 16 18/45 Genotype Assay as part of its acquisition of Gen-Probe Incorporated, which was completed on August 1, 2012. The APTIMA HPV Assay received FDA approval in 2011 and was CE marked in 2008.

As is the case with the Company’s APTIMA HPV Assay, Cervista HPV HR test, and Cervista HPV 16/18 test, the APTIMA HPV 16 18/45 Genotype Assay is performed from Hologic’s ThinPrep liquid cytology specimens, which are routinely collected for pap testing.

The Company expects to begin commercialization of the APTIMA HPV 16 18/45 Genotype Assay during the first quarter of fiscal 2013.

Forward-Looking Statement Disclaimer:

This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of the APTIMA HPV Assays, Cervista HPV tests and the ThinPrep Pap Test. There can be no assurance the tests will achieve the benefits described herein and that such benefits will be replicated in any particular manner as the actual effect of the use of the tests can only be determined on a case-by-case basis depending on the particular circumstances in question. These forward-looking statements are based upon assumptions made by the Company as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated. 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. Certain factors that could adversely affect the Company’s business and prospects are described in Hologic filings with the Securities and Exchange Commission.

About Hologic, Inc.:

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems, and surgical products. The Company operates four core business units focused on diagnostics, breast health, 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. For more information, visit www.hologic.com.

Hologic, APTIMA, Cervista, 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.

SOURCE Hologic, Inc.