Hologic’s Genius Digital Diagnostics System cleared by FDA

Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm has received clearance from the FDA, making it the first and only FDA-cleared digital cytology system that combines deep-learning-based artificial intelligence with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells. Screenings for cervical cancer include a Pap test, where a sample is generally collected at an OB-GYN office, and the cervical cells are sent to a lab where they are transferred to a glass slide. With the Genius Digital Diagnostics System, the glass slides are digitally imaged and an artificial intelligence algorithm is applied to pinpoint the cells that cytologists and pathologists should review. The new process and technology demonstrated an overall improvement in sensitivity without a corresponding decrease in specificity. There was a 28% reduction in false negatives of high-grade squamous intraepithelial and more severe lesions compared to microscopic review. The Genius Digital Diagnostics System is already commercially available in Europe, Australia and New Zealand. Commercial availability in the U.S. is expected in early 2024.