2002 – AutoPap System
FDA Approval for Primary Screening
By TriPath Imaging Inc.
Now FocalPoint™ GS Imaging System by Becton Dickinson Corp.
2003 – ThinPrep® Imaging System
FDA Approval for Primary Screening
By Cytyc Inc.
Now ThinPrep® Imaging System by Hologic Inc.
Automated Screening using Image Analysis
In 1998, the FDA approved the first automated system for cervical smears screening, called the AutoPap System (TriPath Imaging Inc.), followed by approval in 2002 for primary screening using SurePathTM slides. Then, in 2003, the ThinPrep® Imaging System by Cytyc Corporation received approval for ThinPrep® Pap slides. These systems are still in use and select a given number of fields of view (FOV) that the experts must check for abnormalities. If abnormal cells are found in one of these FOV, they have to manually review the whole slide to make their diagnosis.
So for a long time, cervical cancer screening has been limited to the interpretation of what the human eye can view under a microscope. Most of the cytology departments are still using glass slides with standard microscopes. At best, some laboratories are using motorized microscopes with the FOV selections proposed by these automated systems.