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
Hologic, Inc. (Nasdaq: HOLX) announced today that its new
Genius™ Digital Diagnostics System with the Genius™ Cervical AI
algorithm has received clearance from the U.S. Food and Drug
Administration (FDA), making it 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.
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Genius™ Digital Diagnostics System
Station (Graphic: Business Wire)
“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, Ph.D., President,
Diagnostic Solutions at Hologic. “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.”
In its most recent update, the American Cancer Society estimated
that 13,820 cases of invasive cervical cancer will be diagnosed in
the United States in 2024, and approximately 4,360 women will die
from the disease. Detecting and identifying cervical cancer in the
earliest stages is critical to effective prevention and
treatment.
Screenings for cervical cancer include a Pap test, where a
sample is generally collected at an OB-GYN office, and the cervical
cells are sent to a lab where they are transferred to a glass
slide. To date, this glass slide has been reviewed under a
microscope. With the Genius Digital Diagnostics System, the glass
slides are digitally imaged and an artificial intelligence
algorithm is applied to pinpoint the cells that cytologists and
pathologists should review.
The new process and technology demonstrated an overall
improvement in sensitivity without a corresponding decrease in
specificity. Notably, there was a 28% reduction in false negatives
of high-grade squamous intraepithelial and more severe lesions
compared to microscopic review.1 The Genius Digital Diagnostics
System will help laboratories arm healthcare professionals with the
information they need to guide more timely and effective treatment
decisions for patients.
The Genius Digital Diagnostics System also offers the
opportunity for greater collaboration across lab and other
healthcare settings. The system allows cytologists and pathologists
to securely review cases remotely, so patients can benefit from the
collective knowledge of geographically dispersed experts.
The Genius Digital Diagnostics System consists of the Genius™
Digital Imager for image acquisition, the Genius™ Cervical AI
algorithm for image analysis, the Genius™ Image Management Server
for image storage and the Genius™ Review Station for local or
remote case review. The complete system is scalable and designed to
fit the present and future needs of laboratories. The Genius
Digital Diagnostics System is already commercially available in
Europe, Australia and New Zealand. Commercial availability in the
U.S. is expected in early 2024.
About Cervical Cancer Screening
Cervical cancer is preventable and, if caught early, can be
highly treatable. Co-testing — combining a Pap test with an HPV
test — has been shown to be the most sensitive testing option for
cervical cancer screening compared to either test used
alone.2,3,4,5 Hologic pioneered the first FDA-approved liquid-based
cytology test, the ThinPrep® Pap test, and the first FDA-approved
mRNA-based HPV test, the Aptima® HPV Assay. Healthcare
professionals have the choice to perform a co-test with ThinPrep
and Aptima.
About Hologic, Inc.
Hologic, Inc. is a global medical technology innovator focused
on improving the health and well-being of women, their families and
communities through early detection and treatment. Its advancements
include invention of the world’s first commercial 3D mammography
system to find breast cancer earlier; leadership in testing for
cervical cancer, sexually transmitted infections and respiratory
illnesses; minimally invasive surgical technologies for uterine
fibroids and abnormal uterine bleeding; and advanced vessel sealing
and dissection devices.
The company also champions women through the Hologic Global
Women’s Health Index, which provides a science-backed data
framework for improving women’s well-being.
Forward-Looking Statements
This press release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of Hologic products. There can be no assurance these products
will achieve the benefits described herein or that such benefits
will be replicated in any particular manner with respect to an
individual patient, as the actual effect of the use of the products
can only be determined on a case-by-case basis. In addition, there
can be no assurance that these products will be commercially
successful or achieve any expected level of sales. Hologic
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any such statements presented
herein to reflect any change in expectations or any change in
events, conditions or circumstances on which any such statements
are based.
Hologic, The Science of Sure, Aptima, Genius and ThinPrep and
associated logos are trademarks and/or registered trademarks of
Hologic, Inc. and/or its subsidiaries in the United States and/or
other countries.
Source: Hologic, Inc.
____________________
1
Genius Digital Diagnostics System
with the Genius Cervical AI Algorithm Instructions for Use
AW-23890-001. Hologic, Inc.; 2024
2
Austin RM, et al. Enhanced
detection of cervical cancer and precancer through use of imaged
liquid-based cytology in routine cytology and HPV co-testing. Am J
Clin Pathol.2018;150(5):385-392. doi: 10.1093/ajcp/aqy114 (Study
included the ThinPrep® Pap test, ThinPrep imaging, digene HPV,
Cervista HPV and Aptima HPV).
3
Blatt AJ, et al. Comparison of
cervical cancer screening results among 256,648 women in multiple
clinical practices. Cancer Cytopathol. 2015;123(5):282-288.
doi:10.1002/ cncy.21544 (Study included ThinPrep, SurePath and
Hybrid Capture 2 assay).
4
Kaufman H, et al. Contributions
of Liquid-Based (Papanicolaou) Cytology and Human Papillomavirus
Testing in Cotesting for Detection of Cervical Cancer and Precancer
in the United States. Am J Clin Pathol. 2020:XX:0-0 DOI:
10.1093/AJCP/AQAA074 (Study included ThinPrep Pap test, ThinPrep
imaging, SurePath Pap test, SurePath imaging, Aptima HPV assay and
Hybrid Capture 2 HPV assay).
5
Zhou H, et al. Clinical
performance of the Food and Drug Administration-Approved high-risk
HPV test for the detection of high-grade cervicovaginal lesions.
Cancer Cytopathol. 2016 May;124(5):317-23. doi: 10.1002/cncy.21687.
(Study included Cobas HPV, SurePath and ThinPrep).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240131786693/en/
Media Contact: Bridget Perry Director, Corporate
Communications +1 508.263.8654 bridget.perry@hologic.com
Investor Contact: Ryan M. Simon Vice President, Investor
Relations +1 858.410.8514 ryan.simon@hologic.com
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