The US Food and Drug Administration (FDA) has granted clearance for Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm for cervical cancer screening.
This system is claimed to be the first FDA-cleared digital cytology platform that integrates deep-learning-driven artificial intelligence (AI) with volumetric imaging technology.
The development marks a significant advancement in the detection of pre-cancerous lesions and cervical cancer cells.
The Genius Digital Diagnostics System revolutionises the traditional Pap test process by digitising the glass slides and applying an AI algorithm.
This method has shown a notable reduction in false negatives for high-grade lesions, with a 28% improvement compared to standard microscopic review.
Its ability to enhance sensitivity without compromising specificity is a crucial development in patient care, providing more reliable and timely treatment decisions.
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Offering a scalable solution for laboratories, the system’s components include the Genius Digital Imager, Image Management Server, Cervical AI algorithm, and Review Station.
This flexibility ensures that the system can meet both current and future demands.
The Genius Digital Diagnostics System also facilitates greater collaboration by allowing secure remote case reviews, leveraging the expertise of specialists regardless of their location.
Already available in Europe, Australia, and New Zealand, the new system is anticipated to be commercially accessible in the US in early 2024.
Hologic Diagnostic Solutions President Jennifer Schneiders said: “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.
“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.”
Last year, the company secured 510(k) clearance from the US FDA for its fully automated and high-throughput Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.