Hologic(Nasdaq: HOLX)+ announced that the FDA granted clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm.
Clearance makes Genius the first and only FDA-cleared digital cytology system combining deep learning-based AI with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells, according to a news release.
Hologic’s clearance comes within days of a new partnership between BD and Techcyte on AI-based cervical cytology guidance.
Screenings for cervical cancer include a pap test. Generally, a sample is collected at an OB-GYN office and the cervical cells are sent to a lab and transferred to a glass slide. Then, it goes under a microscope. Instead, Genius digitally images the glass slides and applies an AI algorithm to pinpoint cells that cytologists and pathologists should review.
Hologic reports an overall improvement in sensitivity without a corresponding decrease in specificity with this new process. It saw a 28% reduction in false negatives for high-grade squamous intraepithelial and more severe lesions compared to microscopic review.
The company believes Genius helps laboratories bring more information to guide more timely and effective treatment decisions. Genius also enables more collaboration across lab and healthcare settings through remote review capabilities.
Hologic already offers the system in Europe, Australia and New Zealand. It expects a commercial launch in the U.S. early this year.
“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, president, Diagnostic Solutions at Hologic. “The system delivers more actionable and accurate insights for laboratories and healthcare professionals to enhance patient care.”
Hologic’s Q4 earnings beat The Street
For the fourth quarter, the Marlborough, Massachusetts-based company posted profits of $246.5 million. That equals $1.03 per share on sales of $1.01 billion for the three months ended Dec. 30, 2023. Hologic reported a 31.2% bottom-line gain despite a sales decline of 5.7%.
Adjusted to exclude one-time items, earnings per share totaled 98¢. That landed 3¢ ahead of projections on Wall Street. Hologic also posted a sales beat as analysts expected sales of $986.1 million.
“We delivered strong revenue and profitability to start fiscal 2024, exceeding the high-end of our guidance for both the top-line and the bottom-line. Adjusting for the four fewer selling days in the quarter, we estimate our organic growth rate ex. COVID-19 was in the high single digits, highlighting the bigger, faster, stronger Hologic we are today,” said Stephen P. MacMillan, Hologic chair, president and CEO. “Each one of our divisions delivered solid results setting the stage for another strong fiscal year. We are excited to continue our durable and dependable performance as we progress through fiscal 2024.”
Hologic expects 2024 revenue to range between $3.99 billion and $4.065 billion. It expects adjusted EPS between $3.97 and $4.12.
Original article: (https://www.massdevice.com/fda-clears-cervical-cytology-ai-hologic/)