Hologic, Inc. (Hologic or the Company), a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today that the U.S. Food and Drug Administration (FDA) has approved its Cervista HTA (high throughput automation) system for use with the Company's previously approved Cervista human papillomavirus (HPV) HR test. The Company's HPV HR test utilizes Hologic's proprietary Invader technology to detect 14 high risk types of HPV that are associated with cervical cancer and precancerous lesions.
The Company's Cervista HTA system automates the DNA extraction and detection steps of the Hologic Cervista HPV HR test allowing users to walk away after loading the instrument and return the next morning to review the test results.
"Our new Cervista high throughput automation system represents a significant addition to our molecular diagnostics product portfolio," said Rob Cascella, President and Chief Executive Officer of Hologic. "The Cervista HTA system automates our Cervista HPV HR test, providing higher throughput, improved chain of custody and accurate results. We are extremely pleased to get this product approved as it materially changes the competitive landscape for Hologic."
"With over 200 U.S. laboratories currently running our Cervista HPV HR test, we have had tremendous success with the early adoption of our manual HPV test," said Rohan Hastie, Vice President and General Manager, Hologic Molecular Diagnostics. "We believe that our success is driven in large part by physician and laboratory confidence in the performance and comprehensive design of the Cervista HPV assays. Having HTA approved quite simply makes us even more competitive."
Approval of the Cervista HTA system provides Hologic, a world leader in cervical cancer screening, the most complete cervical cancer screening solution available on the market today.
About the ThinPrep Pap Test and Cervista HPV HR and Cervista HPV 16/18 Tests
Research on human papillomavirus has made impressive progress in recent years. Better diagnosis and therapies have helped to significantly reduce the number of new cancer cases, advanced-stage tumors, and ultimately deaths from cervical cancer in particular, which is predominantly caused by HPV. Next to breast cancer, cervical cancer remains the second most frequent cancer affecting women worldwide.
Hologic has been dedicated to the prevention of cervical cancer through screening since the introduction of its ThinPrep Pap Test in 1996. The ThinPrep Pap Test today is the most widely-used liquid based cytology platform in the United States and many other countries of the world. In 2003, Hologic was the first to introduce a computer-guided imaging system for cervical cancer screening with the approval of its ThinPrep Imaging System which has since become the standard of care for the majority of ThinPrep customers. With the approval of the Company's Cervista HTA system, Hologic offers a complete cervical cancer screening solution that is scalable for all laboratory customers.
The Cervista HTA system has the ability to process multiple batch sizes of samples providing high-to-mid-volume laboratories the opportunity to utilize Hologic's automation and use the reagents efficiently.
Hologic's unique combination of cytology and molecular products, including the ThinPrep Pap, Cervista HPV HR and Cervista HPV 16/18 tests, provides a full range of cervical cancer screening technologies for improving women's health.
About Hologic, Inc.
Hologic, Inc. (hologic.com) is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, breast Magnetic Resonance Imaging, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia and uterine fibroids, permanent contraception, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications.
Hologic, Cervista, Invader and ThinPrep 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 the ThinPrep Pap Test, Cervista HPV HR test, Cervista HTA system and ThinPrep Imaging System. There can be no assurance the tests or systems 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 and systems can only be determined on a case-by-case basis depending on the particular circumstances and installation 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. Certain factors that could adversely affect the Company's business and prospects are described in Hologic filings with the Securities and Exchange Commission.
Contact: Deborah R. Gordon, Vice President, Investor Relations - Hologic, Inc.
T: 781-999-7716 - E: deborah.gordon[.]hologic.com.