BD has collaborated with Techcyte, an artificial intelligence (AI)-based digital diagnostics company, for a digital cervical cytology system.
This AI-based algorithm aims to assist cytotechnologists and pathologists in identifying signs of cervical cancer and precancerous lesions effectively through whole-slide imaging.
The partnership between BD and Techcyte is set to deliver a comprehensive solution that reduces the potential for human error and increases laboratory throughput.
The system is designed to enhance the standardisation, reproducibility, and efficiency of results obtained from Pap tests, also known as Pap smears.
BD Diagnostic Solutions acting president Nikos Pavlidis said: “There is a shortage of healthcare laboratory technicians, and the problem is particularly acute in the area of 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.”
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The new digital cervical cytology system will allow for the scanning of samples, converting them to digital slide images, and review on a computer monitor, which can be done in a lab or remotely.
The Techcyte platform is compatible with the most common liquid-based cytology (LBC) preparations, including the BD SurePath Liquid-based Pap Test vial.
It is also intended to be compatible with several widely-used whole-slide imagers.
The system has received a CE mark in Europe for clinical use under the IVD directive.
Techcyte plans to seek full approval from the US Food and Drug Administration (FDA) and CE certification under the IVDR for clinical use.
The AI-based cervical cytology system from BD and Techcyte is expected to be commercially available in Europe in the first half of 2024, with availability in the US pending FDA approval for clinical use.