Becton, Dickinson and Company and Techcyte 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 pre cancer 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 smears. Traditionally, Pap tests have been conducted by taking a sample from a patient and placing it on a glass slide that is visually evaluated 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 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. 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.