Hologic has announced FDA clearance for its Genius Digital Diagnostics System, marking it as the first digital cytology system approved by the FDA that utilizes artificial intelligence (AI) and advanced imaging to enhance cervical cancer screening according to the company. The solution aims to improve the accuracy of detecting pre-cancerous lesions and cervical cancer cells, streamline workflow in laboratories, and elevate patient care standards.

“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, 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.”

The American Cancer Society’s latest data estimates that in 2024, 13,820 new cases of invasive cervical cancer will be diagnosed in the United States, with around 4,360 women expected to die from the disease. The early detection and identification of cervical cancer are crucial for effective prevention and treatment.

The traditional screening process involves reviewing samples collected during a Pap test under a microscope. The Genius Digital Diagnostics System transforms this process by digitizing the samples and applying an AI algorithm to highlight areas for cytologists and pathologists to review. This new method has shown improvement in sensitivity and a 28% reduction in false negatives for high-grade squamous intraepithelial lesions, offering a more reliable screening process.

Moreover, the Genius Digital Diagnostics System enables greater collaboration across healthcare settings by allowing secure remote case reviews. This feature ensures that patients can benefit from the expertise of medical professionals, regardless of their location.

The system comprises several components, including 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 case review. Designed to be scalable, the system can adapt to the needs of various laboratory sizes. While already available in Europe, Australia, and New Zealand, Hologic anticipates the system’s commercial availability in the U.S. in early 2024.

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