BD and Techcyte has collaborated 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.
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, 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.
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.
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