Hologic ThinPrep Imaging System Gets CE Mark for Cervical Cancer Detection

This is not a huge story for us here, but in Europe the product now has approval, for the dual system detection. At the site, there’s a video that explains the higher level of accuracy and detection by using both human and machine capabilities. BD

From the website:

The ThinPrep Imaging System represents a significant advance in diagnostic capability, with two unique components for comprehensive and accurate cervical cancer testing. The ThinPrep Pap Test offers several advantages over the conventional pap smear, including improved disease detection and testing for HPV, Chlamydia, and Gonorrhea straight from the vial, and the ThinPrep Imaging System with Dual Review offers additional advantages over manually reviewed ThinPrep Pap Test slides.

Hologic Inc. won CE Mark approval in the European Union for its ThinPrep integrated imager for cervical cancer.

The Bedford, Mass.-based women's health products maker said the approval clears the way for it to bring the device to market in the EU's 27 member countries, plus the three European Free Trade Assn. members and other nations that recognize the mark.

The ThinPrep device integrates imaging technology and slide review into a single device. It works by analyzing a Pap smear slide, scanning each cell or cell cluster and flagging "diagnostically relevant" cells or cell groups, according to a press release.