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FDA clears new cervical cytology AI tech from Hologic

Hologic (Nasdaq: HOLX)+ announced that the FDA granted clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm.

Clearance makes Genius the first and only FDA-cleared digital cytology system combining deep learning-based AI with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells, according to a news release.

Hologic’s clearance comes within days of a new partnership between BD and Techcyte on AI-based cervical cytology guidance.

Screenings for cervical cancer include a pap test. Generally, a sample is collected at an OB-GYN office and the cervical cells are sent to a lab and transferred to a glass slide. Then, it goes under a microscope. Instead, Genius digitally images the glass slides and applies an AI algorithm to pinpoint cells that cytologists and pathologists should review.

Hologic reports an overall improvement in sensitivity without a corresponding decrease in specificity with this new process. It saw a 28% reduction in false negatives for high-grade squamous intraepithelial and more severe lesions compared to microscopic review.

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