BD and Techcyte Collaborate on AI-Based Digital Cervical Cytology System for Pap Testing

Cervical cancer is a global health concern, responsible for over 340,000 deaths among women each year. Ranking as the fourth most common cancer in women, its mortality rate can be significantly reduced with comprehensive screening strategies. While healthcare guidance is increasingly favoring HPV screening as the primary method for cervical cancer detection, Pap tests, or Pap smears, remain crucial. They are essential during the transition to HPV screening as the standard of care and for examining precancerous conditions and cancer following the detection of high-risk HPV infections. About one in 10 HPV tests yield positive results, which are then followed up with a Pap test for a visual examination of the cells.

Traditionally, Pap tests have involved collecting a sample from the patient, placing it on a glass slide, and having it examined under a microscope by a cytotechnologist or pathologist. Now, a new strategic collaboration aims to offer an AI-based algorithm to assist cytologists and pathologists in efficiently and effectively identifying signs of cervical cancer and precancer through whole-slide imaging. BD (Becton, Dickinson and Company, Franklin Lakes, NJ, USA) and Techcyte (Orem, UT, USA) have entered into an agreement that will allow BD to provide a comprehensive solution aimed at minimizing human error and increasing throughput. This will help laboratories enhance the standardization, reproducibility, and efficiency of Pap test results.

With the digital cervical cytology system, the samples can be scanned, converted to a digital slide image, and then reviewed on a computer monitor in a lab or from a remote location. In addition, the digital cervical cytology system uses an AI-based algorithm to prioritize and present clinically relevant cells for visual evaluation. The Techcyte platform is compatible with the most common liquid based cytology (LBC) preparations, including BD SurePath Liquid-based Pap Test vial and aims to be compatible with several of the most-used whole-slide imagers on the market. The Techcyte system is CE-marked per the IVD directive (98/79/EC) for clinical use in Europe, and Techcyte intends to seek full U.S. FDA approval for clinical use and CE certification to the IVDR (EU)2017/746. The BD and Techcyte IVDD solution will be commercially available in Europe in the first half of 2024, and in the U.S. subject to FDA approval for clinical use.

"There is a shortage of health care laboratory technicians, and the problem is particularly acute in the area of cytology" said Nikos Pavlidis, acting president of Diagnostic Solutions at BD. "This solution helps solve for the dearth of expert cytologists by leveraging new AI-based digital technology to make the testing process efficient and bring the traditional Pap test into the 21st century."

"Eye strain, fatigue, distractions, and intense workloads can make manually reading Pap smears difficult," added Ben Cahoon, CEO of Techcyte. "Our digital workflow supported by an AI-based algorithm can assist lab professionals in delivering consistent results for their patients. Our system presents the most diagnostically relevant cell images to guide the cytotechnologists and pathologists for efficient review and better decision making."

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