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.