CytoProcessor<sup>TM</sup>: A New Cervical Cancer Screening System for Remote Diagnosis

<b><i>Background:</i></b> Current automated cervical cytology screening systems still heavily depend on manipulation of glass slides. We developed a new system called CytoProcessor^TM (DATEXIM, Caen, France), which increases sensitivity and takes advantage of virtual slide technology to simplify the workflow and save worker time. We used an approach based on artificial intelligence to identify abnormal cells among the tens of thousands in a cervical preparation. <b><i>Objectives:</i></b> We set out to compare the diagnostic sensitivity and specificity of CytoProcessor^TM and the ThinPrep Imaging System (HOLOGIC, Marlborough, MA, USA). <b><i>Methods:</i></b> A representative population of 1,352 cases was selected from the routine workflow in a private laboratory. Diagnoses were established using the ThinPrep Imaging System and CytoProcessor^TM. All discordances were resolved by a consensus committee. <b><i>Results:</i></b> Compared to the ThinPrep Imaging System, CytoProcessor^TM significantly improves diagnostic sensitivity without compromising specificity. The sensitivity of detection of “atypical squamous cells of undetermined significance (ASC-US) and more severe” and “low-grade squamous intraepithelial lesion and more severe” was significantly higher using CytoProcessor^TM. Considering that cases with a truth diagnosis of ASC-US or more severe required clinical follow-up, 1.5% of the cases (21/1,360) would have been missed if the CytoProcessor^TM diagnosis had been used for clinical decision-making. In contrast, 4% of the cases (54/1,360) were missed when the ThinPrep Imaging System diagnosis was used for clinical decision-making. There were 2.6 times fewer false negatives using CytoProcessor^TM. The CytoProcessor^TM workflow was 1.5 times faster in terms of worker time. <b><i>Conclusions:</i></b> CytoProcessor^TM is the first of a new generation of automated screening systems, demonstrating improved sensitivity and yielding significant gains in processing time. In addition, the fully digital nature of slide presentation in CytoProcessor^TM allows the remote diagnosis of Papanicolaou tests for the first time.