Hologic Introduces Genius™ Digital Diagnostics System, the First and Sole FDA-Cleared Digital Cytology System

everaging Advanced Imaging and Innovative Artificial Intelligence, the Latest Diagnostic System Enhances Cervical Cancer Screening Accuracy, Workflow Efficiency, and Patient Care

Hologic, Inc. (Nasdaq: HOLX) has announced that its groundbreaking Genius™ Digital Diagnostics System, featuring the Genius™ Cervical AI algorithm, has received approval from the U.S. Food and Drug Administration (FDA). This marks a significant milestone as the system becomes the first and only FDA-cleared digital cytology system integrating deep-learning-based artificial intelligence (AI) with advanced volumetric imaging technology. The primary purpose of this innovative system is to aid in the identification of 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,” expressed Jennifer Schneiders, Ph.D., 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.”

According to the most recent update from the American Cancer Society, an estimated 13,820 cases of invasive cervical cancer are expected to be diagnosed in the United States in 2024, with approximately 4,360 women projected to succumb to the disease. The early detection and identification of cervical cancer are crucial for effective prevention and treatment.

Traditional cervical cancer screenings involve a Pap test, where a sample is collected at an OB-GYN office, and the cervical cells are sent to a lab, typically transferred to a glass slide, and reviewed under a microscope. The Genius Digital Diagnostics System transforms this process by digitally imaging the glass slides and applying an artificial intelligence algorithm to pinpoint the cells that require review by cytologists and pathologists.

This revolutionary approach and technology demonstrated an overall improvement in sensitivity without compromising specificity. Particularly noteworthy is the 28% reduction in false negatives of high-grade squamous intraepithelial and more severe lesions compared to microscopic review. The Genius Digital Diagnostics System is poised to equip laboratories and healthcare professionals with the information needed to make more timely and effective treatment decisions for patients.

Additionally, the system encourages enhanced collaboration across laboratories and other healthcare settings. It enables cytologists and pathologists to securely review cases remotely, facilitating patients’ access to the collective knowledge of geographically dispersed experts.

The Genius Digital Diagnostics System comprises 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. Designed to meet the present and future needs of laboratories, the scalable system is already commercially available in Europe, Australia, and New Zealand, with U.S. commercial availability anticipated in early 2024.

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