Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), 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."