NEW YORK – Becton Dickinson on Tuesday announced that it will collaborate with artificial intelligence developer TechCyte to create an AI-based digital cervical cytology system for Pap testing. The algorithm will help guide cytologists and pathologists in the identification of cervical cancer and pre-cancer using whole-slide imaging. The complete solution aims to reduce the potential for human error and enable greater throughput, BD said in a statement.
Financial terms of the collaboration were not disclosed.
Pap tests, also known as Pap smears, are cervical specimens evaluated for structural and cellular abnormalities by a cytologist or pathologist using a microscope.
With the digital cervical cytology system, samples can instead be scanned, converted to a digital slide image, and later reviewed on a computer monitor in a lab or from a remote location, BD said.
"Eye strain, fatigue, distractions, and intense workloads can make manually reading Pap smears difficult," TechCyte CEO Ben Cahoon said in a statement.
The TechCyte digital workflow is supported by an AI-based algorithm that presents the most diagnostically relevant cell images to enable efficient review and improve decision-making, he added.
Nikos Pavlidis, acting president of Diagnostic Solutions at BD, noted that there is an ongoing shortage of skilled lab technicians, particularly in cytology.
"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," Pavlidis said.
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, BD said.
Although guidance has been shifting to recommend HPV screening as the primary test for cervical cancer, Pap tests continue to play an important diagnostic role as programs are transitioning to the new standard of care, and in looking for pre-cancer and cancer when a high-risk HPV infection is detected, BD also said, adding that 1 in 10 HPV tests are positive, and positive results are then referred to a Pap test for visual inspection of cells.
The TechCyte system is CE-marked per the IVD directive for clinical use in Europe, and TechCyte intends to seek full US Food and Drug Administration approval for clinical use and CE certification under the In Vitro Diagnostic Regulation, BD said. The BD and TechCyte IVDD solution will be commercially available in Europe in the first half of 2024.