Reply to a validation study of the Focalpoint GS imaging system for gynecologic cytology screening


We thank Drs. Renshaw and Elsheikh for their interest in our article.[1] As we noted, the purpose of our validation study was to document the function and capabilities of the FocalPoint Guided Screening imaging system in our own laboratory environment. It is our opinion that good laboratory practice required such a validation study. We should anticipate the need for future validation studies of novel digital imaging technologies that are currently being considered for introduction into anatomical pathology practice.

The discussion section of our article makes a similar observation regarding the potential effects of workload with respect to the United Kingdom–Manual Assessment Versus Automated Reading in Cytology (MAVARIC) trial.[1] However, workload and productivity parameters were not used as outcome measures in our article. Without these outcomes, our study cannot support, or refute, the conclusions of Drs. Renshaw and Elsheikh. Clearly, workload and productivity need to be considered in addition to function and capabilities when assessing digital imaging technologies.

  • Terrence Colgan, MD

  • Department of Pathology and Laboratory Medicine

  • Mount Sinai Hospital

  • Toronto, Ontario, Canada