Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced it has received CE marking approval for its ThinPrep® integrated imager. The ThinPrep integrated imager was introduced and on display at the 35th European Congress of Cytology this week in Lisbon, Portugal.
The integrated imager represents the latest innovation in cervical cancer screening by combining proven ThinPrep imaging technology and slide review into a single, convenient stand-alone device. This exciting new product offering allows laboratories of all sizes to benefit from clinical advantages of ThinPrep imaging for cervical screening.
"This represents a tremendous opportunity for Hologic and our current and future laboratory partners throughout Europe," said Howard Doran, senior vice president, diagnostics products for Hologic. "The ThinPrep integrated imager is designed to provide the small and medium volume laboratory access to the most effective and efficient cytology screening technology available, while allowing them the flexibility to address their specific productivity and throughput needs." The majority of laboratories in Europe would fall into the small or medium category.
The integrated imager analyzes a ThinPrep Pap test slide in approximately 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 stores coordinates of the 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. This dual review process combines human interpretative expertise with the power of computer imaging.
Hologic's experience working with ThinPrep Pap test users contributed significantly to the integrated imager development. Every feature is designed to enable the cytotechnologist to perform slide review effectively and efficiently. The integrated imager can also be used as a conventional microscope saving valuable lab space.
CE marking approval allows Hologic to market the ThinPrep integrated imager in the 27 countries of the European Union (EU) and three of the four member states of the European Free Trade Association (EFTA). CE marking is recognized in many countries outside the European Economic Area giving Hologic the ability to supply systems to a number of markets internationally. The ThinPrep integrated imager is currently not approved by the U.S. Food and Drug Administration.