FRANKLIN LAKES, N.J. and OREM, Utah, Jan. 30, 2024 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Techcyte, a world leader in artificial intelligence (AI)-based digital diagnostics, today announced a strategic collaboration agreement to offer an AI-based Pap testing solution algorithm that guides cytologists and pathologists to efficiently and effectively identify evidence of cervical cancer and precancer using whole-slide imaging.
The agreement enables BD to deliver a complete solution that aims to reduce the potential for human error and enable greater throughput, so that labs can achieve their results with greater standardization, reproducibility, and efficiency from a Pap test, also known as a Pap smear.
Traditionally, cytotechnologists or pathologists visually evaluated patient samples on a glass slide for Pap tests. The digital cervical cytology system scans and converts samples into digital slide images, enabling review on a computer monitor in a lab or remotely. In addition, the digital cervical cytology system uses an AI-based algorithm to prioritize 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 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.”
Also Read: BD Receives FDA Clearance for Fingertip Blood Collection Device
Cervical cancer claims the lives of over 340,000 women worldwide annually, ranking as the fourth most common cancer in women. A comprehensive approach, emphasizing effective screening, could significantly reduce its high mortality rate. While healthcare guidance is increasingly advocating HPV screening as the primary cervical cancer test, Pap tests will maintain a crucial diagnostic role during the transition to the new standard of care. Programs will continue to rely on Pap tests for visual cell inspection when a high-risk HPV infection is detected, as one in 10 HPV tests yields positive results leading to further examination.
Also Read: BD’s Survey Reveals Disparities in Cervical Cancer Screening
Techcyte has CE-marked the system for clinical use in Europe per the IVD directive (98/79/EC) and intends to pursue full U.S. approval. 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.
