Hologic recently declared that it has received CE marking approval for its ThinPrep integrated imager. Apparently, the integrated imager represents the most modern innovation in cervical cancer screening. This is because it appears to combine established ThinPrep imaging technology and slide review into a single, convenient stand-alone device.
Furthermore, this exciting novel product offering seems to permit various laboratories to gain from clinical advantages of ThinPrep imaging for the purpose of cervical screening.
“This represents a tremendous opportunity for Hologic and our current and future laboratory partners throughout Europe,” says 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.”
Majority of laboratories in Europe may possibly fall into the small or medium category. It was observed that the integrated imager analyzes a ThinPrep Pap test slide in about 90 seconds, during which time of every cell and cell cluster is scanned.
With the help of optical density analysis, the integrated imager appears to recognize diagnostically-relevant cells or cell groups. It is noted to then store coordinates of the 22 fields of interest. These 22 fields of interest may perhaps be presented to the cytotechnologist for understanding.
If the cytotechnologist identifies no defect, the slide could be signed out as negative or carried on through the laboratory quality control system. However, a complete slide review is needed if the user detects any suspicious cells within the 22 fields of view. Supposedly, this dual review process combines human interpretative expertise with the power of computer imaging.
Hologic’s experience working with ThinPrep Pap test users seems to have contributed considerably to the integrated imager development. The ThinPrep integrated imager was believed to have been introduced and on display at the 35th European Congress of Cytology this week in Lisbon, Portugal.
Every feature is designed in order to enable the cytotechnologist to perform slide review effectively and efficiently. Additionally, the integrated imager could possibly be used as a conventional microscope saving valuable lab space. It was believed that CE marking approval allows Hologic to promote the ThinPrep integrated imager in the 27 countries of the European Union (EU) as well as in three of the four member states of the European Free Trade Association (EFTA).
CE marking is noted to be recognized in many countries outside the European Economic Area thereby providing Hologic the ability to supply systems to a number of markets across the world. However, at present, the U.S. Food and Drug Administration have not yet approved the ThinPrep integrated imager.