BD (Becton, Dickinson and Company) and artificial intelligence (AI)-based digital diagnostics firm Techcyte have announced a strategic collaboration agreement to offer an AI-based algorithm that guides cytologists and pathologists to efficiently and effectively identify evidence of cervical cancer and precancer using whole-slide imaging.
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. The agreement enables BD to deliver a complete solution that aims to reduce the potential for human error and enable greater throughput, so that laboratories can achieve their results with greater standardisation, reproducibility, and efficiency from a Pap test, also known as a Pap smear.
Traditionally, Pap tests use glass slides which are visually by a cytotechnologist or pathologist using a microscope. 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 laboratory or from a remote location. In addition, the digital cervical cytology system uses an AI-based algorithm to prioritise and present clinically relevant cells for visual evaluation.
"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."
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.
"Eye strain, fatigue, distractions, and intense workloads can make manually reading Pap smears difficult," said Ben Cahoon, CEO of Techcyte. "Our digital workflow supported by an AI-based algorithm can assist laboratory 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."
Globally, cervical cancer kills more than 340,000 women annually. It is the fourth most frequently observed cancer in women, and its high mortality rate could be reduced through a comprehensive approach that includes effective screening. Although the guidance within health care is shifting to recommending HPV screening as the primary test for cervical cancer, Pap tests will continue to play an important diagnostic role, as programs are transitioning to the new standard of care and in looking for precancer and cancer when a high-risk HPV infection is detected. One 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 (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.