Hologic
(NASDAQ:HOLX)
The FDA has announced the clearance of the Genius Digital Diagnostic System, powered by the Genius Cervical AI algorithm.
With the clearance, Genius will develop the first and only FDA-cleared digital cytology system that combines deep learning-based AI and advanced volumetric imaging technology to help identify precancerous lesions and cervical cancer cells, according to a news release. It will be.
Hologic's approval comes within days of BD and Techcyte's new partnership for AI-based cervical cytology guidance.
Screening for cervical cancer includes a Pap test. Typically, the sample is collected at the gynecology clinic, and the cervical cells are sent to the lab and transferred to glass slides. Next, examine it under a microscope. Instead, Genius digitally images glass slides and applies AI algorithms to identify cells for cytologists and pathologists to examine.
Hologic reports that this new process increases overall sensitivity without decreasing specificity. Compared with microscopy, there was a 28% reduction in false negatives for high-grade squamous intraepithelial lesions and more severe lesions.
The company believes Genius will help bring more information to the laboratory and guide more timely and effective treatment decisions. Genius can also further enhance collaboration across labs and clinical settings through remote review capabilities.
Hologic already offers the system in Europe, Australia and New Zealand. It is scheduled for commercial release in the United States early this year.
“From the first liquid-based cytology test to the first 3D mammography system and now the first FDA-cleared digital cytology platform, Hologic is leading the way in cervical and breast cancer screening technology,” said Jennifer Schneiders. She is a leading innovator in women's health who is committed to progress.” , President of Diagnostic Solutions, Hologic. “This system provides labs and medical professionals with more actionable and accurate insights to enhance patient care.”
Hologic's fourth-quarter profit beat The Street
The Marlboro, Massachusetts-based company posted a profit of $246.5 million in the fourth quarter. This equates to $1.03 per share on his $1.01 billion in sales for the three months ending December 30, 2023. Hologic reported a bottom line profit of 31.2% even though sales were down his 5.7%.
Earnings per share, adjusted to exclude one-time items, totaled 98 cents. This came in 3 cents higher than Wall Street expected. Hologic also posted revenue that beat analysts' expectations for sales of $986.1 million.
“We delivered strong revenue and profitability heading into fiscal 2024, exceeding the high end of our guidance on both top and bottom lines, adjusting for four fewer sales days in the quarter. “COVID-19, in the low single digits, has highlighted that Hologic is bigger, faster and stronger today,” said Hologic Chairman and CEO. said Stephen P. McMillan, President and CEO. “Our divisions delivered solid results and set us up for another strong fiscal year. We are excited to continue our durable and reliable performance through fiscal 2024. .”
Hologic expects 2024 sales to be in the range of $3.99 billion to $4.065 billion. Adjusted EPS is expected to be between $3.97 and $4.12.
