FDA OKs Hologic, Inc. (HOLX)'s APTIMA Trichomonas
1/14/2013 6:42:56 AM
BEDFORD, Mass., Jan. 14, 2013 /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 cleared for marketing its APTIMA Trichomonas vaginalis Assay on the Company's fully-automated PANTHER System.
The APTIMA Trichomonas vaginalis Assay, first cleared for use on Hologic's TIGRIS System in April 2011, remains the only FDA-cleared amplified nucleic acid test on the market specifically cleared to detect Trichomonas vaginalis, the most common curable sexually transmitted infection in the United States. The assay may be used to test clinician-collected endocervical or vaginal swabs, and specimens collected in Hologic's ThinPrep vial from symptomatic or asymptomatic women.
"The PANTHER System is a world class automation solution for a broad range of laboratories," said Rob Cascella, President and Chief Executive Officer. "Expanding the menu of available assays on this system builds on our strategy of delivering workflow and revenue efficiencies to our laboratory partners. We are excited to have APTIMA trichomonas available on PANTHER and look forward to further expanding our menu with high-value assays over the next year and beyond."
Trichomonas is a sexually transmitted parasite estimated by the U.S. Centers for Disease Control to cause 7.4 million infections in the U.S. annually. Trichomonas vaginalis has been linked to several serious health outcomes including female infertility, pelvic inflammatory disease, premature births, low birth weight and increased risk of HIV transmission.
Current techniques for the diagnosis and screening of Trichomonas have limitations in comparison to nucleic acid testing. Most testing is currently done via culture methods, which are slow and less sensitive than molecular assays, or a "wet mount," which requires the microscopic examination of a sample shortly after it is collected and is even less sensitive than culture.
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 Trichomonas vaginalis Assay and the PANTHER System. There can be no assurance the test 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 test 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, ThinPrep, PANTHER 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.