MARLBOROUGH, MA — Hologic, Inc. (Nasdaq: HOLX) announced that its new Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm has received clearance from the U.S. Food and Drug Administration (FDA), making it the first and only FDA-cleared digital cytology system that combines deep-learning-based artificial intelligence (AI) with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells.
“Hologic is a leading innovator in women’s health with a commitment to advancing cervical and breast cancer screening technologies, from the first liquid-based cytology test to the first 3D mammography system and now the first FDA-cleared digital cytology platform,” said Jennifer Schneiders, PhD, President, Diagnostic Solutions at Hologic. “Our technologies have had a tremendous impact on decreasing cancer rates in women, and we are incredibly excited by the promise of Genius Digital Diagnostics. The system delivers more actionable and accurate insights for laboratories and healthcare professionals to enhance patient care.”
In its most recent update, the American Cancer Society estimated that 13,820 cases of invasive cervical cancer will be diagnosed in the United States in 2024, and approximately 4,360 women will die from the disease. Detecting and identifying cervical cancer in the earliest stages is critical to effective prevention and treatment.
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. To date, this glass slide has been reviewed under a microscope. 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. Notably, there was a 28 percent reduction in false negatives of high-grade squamous intraepithelial and more severe lesions compared to microscopic review.1 The Genius Digital Diagnostics System will help laboratories arm healthcare professionals with the information they need to guide more timely and effective treatment decisions for patients.
The Genius Digital Diagnostics System also offers the opportunity for greater collaboration across lab and other healthcare settings. The system allows cytologists and pathologists to securely review cases remotely, so patients can benefit from the collective knowledge of geographically dispersed experts.
The Genius Digital Diagnostics System consists of the Genius™ Digital Imager for image acquisition, the Genius™ Cervical AI algorithm for image analysis, the Genius™ Image Management Server for image storage and the Genius™ Review Station for local or remote case review. The complete system is scalable and designed to fit the present and future needs of laboratories. The Genius Digital Diagnostics System is already commercially available in Europe, Australia, and New Zealand. Commercial availability in the US is expected in early 2024.