Hologic, Inc. HOLX recently launched new FDA approved Genius Digital Diagnostics System with the Genius Cervical AI algorithm. The launch marks the first and only FDA-cleared digital cytology system that combines deep-learning-based artificial intelligence (AI) with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells.
According to American Cancer Society's most current projection, 4,360 women would lose their lives to invasive cervical cancer in the United States in 2024, accounting for 13,820 new instances of the illness. Effective prevention and treatment of cervical cancer depend on early detection and identification of the disease.
More on Genius Digital Diagnostics System
Genius Digital Diagnostics System is comprised Genius Digital Imager for capturing images, Genius Cervical AI algorithm for analyzing images, Genius Image Management Server for storing images and Genius Review Station for conducting in-person or remote case reviews.
The entire system is expandable and made to meet the demands of labs both now and in the future. Australia, New Zealand and Europe have already seen the commercial release of Genius Digital Diagnostics System. In early 2024, it is anticipated to be commercial available in the United States.
The novel procedure and technology showed a general increase in sensitivity without a commensurate drop in specificity. Compared with microscopic review, there was a notable 28% decrease in false negatives of high-grade squamous intraepithelial and more severe lesions.
Significance of the Launch
Hologic is a pioneer in women's health, having developed the first liquid-based cytology test, the first 3D mammography system and FDA-approved digital cytology platform. Per management, the company is dedicated to furthering the technologies for cervical and breast cancer screening. Through a combination of advanced imaging and novel artificial intelligence, latest diagnostic system for cervical cancer screening can help more accurately detect disease, improve workflow and enhance patient care.
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Genius Digital Diagnostics System will assist laboratories and healthcare providers with the information they need to make more timely and successful treatment decisions for patients. The system also allows for improved collaboration across labs and other healthcare facilities. The solution enables cytologists and pathologists to securely assess cases remotely, allowing patients to benefit from the combined knowledge of geographically dispersed professionals.
Industry Prospects
Per Grand View Research, the global cervical cancer diagnostic market size was valued at $4.5 billion in 2022 and is expected to grow at a CAGR of 5.7% from 2023 to 2030. The increasing prevalence of cervical cancer in middle-aged women and the subsequent increase in screening and diagnostic tests are expected to boost the market.
Progress in Molecular Diagnostics Business
Hologic’s Molecular Diagnostics business is registering strong growth driven by a combination of both newer assays like BV, CV/TV and contributions from Amgen and HSV as well as strong growth from longstanding women's health menu.
The company’s Biotheranostics business (acquired in 2021) is consistently delivering double-digit growth, being accretive even to its Molecular growth rate.
In 2023, Biotheranostics grew over 30% and is still in the early innings of boosting the Breast Cancer Index (BCI) test. BCI is still the only test recognized by National Comprehensive Cancer Network guidelines and American Society of Clinical Oncology to predict that patients are likely to benefit from extended adjuvant therapy beyond five years, yet another example of an innovative and differentiated product.
Price Performance
In the past year, shares of Hologic have declined 16.4% against the industry’s 1.2% growth.
Zacks Rank and Other Key Picks
HOLX currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks to consider in the broader medical space are Universal Health Services UHS, Integer Holdings Corporation ITGR and DaVita DVA.
Universal Health Services, carrying a Zacks Rank #2 at present, has an estimated growth rate of 4.4% for 2024. UHS’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 5.47%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
UHS’ shares have gained 13.2% in the past year compared with the industry’s 19.8% growth.
Integer Holdings, presently carrying a Zacks Rank of 2, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 11.9%.
Integer Holdings’ shares have rallied 40% in the past year against the industry’s 1.2% growth.
Estimates for DaVita’s 2023 earnings per share have remained constant at $8.07 in the past 30 days. Shares of the company have increased 30.7% in the past year compared with the industry’s 6.2% growth.
DVA’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 36.6%. In the last reported quarter, it delivered an average earnings surprise of 48.4%.
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