Hologic’s Genius Digital Diagnostics System Gains FDA Clearance for AI-Enhanced Cervical Cancer Detection

Hologic has received FDA clearance for its Genius digital diagnostics system, featuring the Genius cervical AI algorithm. This milestone positions Genius as the first FDA-cleared digital cytology system combining deep learning-based AI with advanced volumetric imaging technology for the identification of precancerous lesions and cervical cancer cells. The system digitally images glass slides from pap tests, applying AI algorithms to pinpoint cells for review by cytologists and pathologists. Hologic reports a notable 28% reduction in false negatives for high-grade squamous intraepithelial and more severe lesions compared to traditional microscopic review, showcasing an improvement in sensitivity without compromising specificity.

The Genius system, already available in Europe, Australia, and New Zealand, is set for a commercial launch in the U.S. early this year. Hologic's commitment to advancing women's health technologies is highlighted by this FDA clearance, offering enhanced insights for healthcare professionals and laboratories to improve patient care. In addition to this regulatory achievement, Hologic posted strong fourth-quarter profits of $246 million, translating to $1.03 per share, on sales of $1 billion for the three months ended December 30, 2023. The company's robust financial performance sets the stage for continued growth in fiscal 2024, with revenue expected to range between $3 billion and $4 billion.

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