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FDA clears Hologic's AI-based cervical cancer screening system

EditorLina Guerrero
Published 02/01/2024, 06:36 PM
© Reuters.
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MARLBOROUGH, Mass. - Hologic, Inc. (NASDAQ:HOLX), a medical technology company, has received FDA clearance for its Genius™ Digital Diagnostics System, which utilizes artificial intelligence (AI) for cervical cancer screening. This system is the first FDA-cleared digital cytology platform that employs a deep-learning AI algorithm combined with advanced imaging to detect pre-cancerous lesions and cervical cancer cells.

The Genius Digital Diagnostics System aims to improve the sensitivity of cervical cancer screenings without compromising specificity. It has shown a 28% reduction in false negatives for high-grade squamous intraepithelial lesions and more severe cases compared to traditional microscopic review.

The system's components include the Genius™ Digital Imager for capturing images, the Genius™ Cervical AI algorithm for analysis, the Genius™ Image Management Server for storage, and the Genius™ Review Station for case review, which can be accessed locally or remotely. This remote review capability facilitates collaboration among experts, regardless of their location, which could be particularly beneficial for patients requiring specialized care.

Hologic's new system is designed to be scalable and adaptable to meet the evolving needs of laboratories. The technology is already available commercially in Europe, Australia, and New Zealand, with plans for a U.S. launch in early 2024.

The American Cancer Society estimates that in 2024, there will be 13,820 new cases of invasive cervical cancer in the U.S., with about 4,360 deaths. Early detection is crucial for effective prevention and treatment, and the Genius Digital Diagnostics System represents a significant advancement in the field of cervical cancer screening.

InvestingPro Insights

As Hologic, Inc. (NASDAQ:HOLX) continues to innovate in the field of medical technology with its FDA-cleared Genius™ Digital Diagnostics System, InvestingPro data indicates a market capitalization of $17.47 billion, reflecting the company's substantial presence in the healthcare sector. With a P/E ratio standing at 40.28 and an adjusted P/E ratio for the last twelve months as of Q4 2023 at 25.71, investors may find the company trading at a high earnings multiple. This could suggest expectations of future growth, aligning with the InvestingPro Tip that net income is expected to grow this year.

The company's financial health appears robust, with gross profit margins for the last twelve months as of Q4 2023 at 61.57%, indicating strong profitability in its operations. Additionally, the InvestingPro Tips highlight that Hologic has been aggressively buying back shares and operates with a moderate level of debt, which could be reassuring for investors concerned about financial stability.

For those considering adding Hologic to their portfolio, InvestingPro+ offers even more insights. Subscribers can access additional tips, such as the company's low price volatility and the fact that its liquid assets exceed short-term obligations. With a special New Year sale, investors can now get up to 50% off on a subscription, plus an extra 10% off a 2-year InvestingPro+ subscription with coupon code SFY24, or an extra 10% off a 1-year subscription with coupon code SFY241. In total, there are 9 additional InvestingPro Tips available for Hologic, which could provide valuable guidance for making informed investment decisions.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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