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GEN News Highlights : Dec 16, 2011

FDA Clears Hologic’s Automated Platform for Cervical Cancer Cervista HPV Assay

Cervista HTA system automates DNA extraction and detection procedures.

FDA approved Hologic’s Cervista HTA (high-throughput automation) system for use with the firm’s already cleared Cervista human papillomavirus (HPV) HR test. The assay uses Hologic’s Invader technology to detect 14 high-risk HPV types associated with cervical cancer and precancerous lesions.

The newly approved Cervista HTA system, designed primarily for mid-to-high volume laboratories, automates the DNA extraction and detection steps of the HPV assay, enabling walk-away operation. Hologic claims that over 200 U.S. laboratories are already running the Cervista HPV HR test, and approval of the automated system will enable increased throughput and accuracy.

“Our new Cervista high-throughput automation system represents a significant addition to our molecular diagnostic product portfolio,” comments Rob Cascella, president and CEO. “We are extremely pleased to get this product approved as it materially changes the competitive landscape for Hologic.  

Hologic claims it now offers a complete cervical cancer screening solution for all sizes of laboratories. The firm’s liquid-based cytology platform, ThinPrep Pap Test, was first introduced in the U.S. in 1996. The ThinPrep Imaging System was launched in 2003.