Hologic has received CE mark approval for its ThinPrep integrated imager, which was introduced at the 35 th European Congress of Cytology this week in Lisbon, Portugal.
According to the Bedford, Mass.-based company, the integrated imager combines ThinPrep imaging technology and slide review into a single, stand-alone device to screen for cervical cancer.
The majority of European labs fall into the small or medium category, and the imager is designed to appeal to those laboratories, said the company. The imager can analyze a ThinPrep Pap test slide in 90 seconds, during which time each cell and cell cluster is scanned.
Using optical density analysis, the integrated imager identifies diagnostically-relevant cells or cell groups and then coordinates 22 fields of interest. These 22 fields of interest are presented to the cytotechnologist for interpretation. If no abnormalities are identified by the cytotechnologist, the slide can be signed out as negative or proceed through the laboratory quality control system. A complete slide review is required if the user detects any suspicious cells within the 22 fields of view.