iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader
providing innovative cancer detection and therapy solutions, today
announced that promising clinical research supporting ProFound AI®
Risk for Digital Breast Tomosynthesis (DBT) – the world’s first
clinical decision support tool that provides an accurate short-term
breast cancer risk estimation based on age, breast density and
mammographic features – was recently published in the peer-reviewed
journal, Science Translational Medicine.i
In the study, which involved 154,200 women screened at four
participating U.S. screening sitesii using DBT from 2014-2019,
researchers at the Karolinska Institutet in Stockholm, Sweden found
ProFound AI Risk accurately determined women who were at a higher
risk of developing breast cancer, with an area under the receiver
operating characteristics curve (AUC) of 0.82i, (95% CI 0.79-0.85).
AUC is a standard performance measurement for examination
procedures that incorporates sensitivity and specificity into a
single metric of overall performance. This data supports iCAD’s
internal research, which previously found ProFound AI Risk for DBT
offers an AUC of 0.80 (95% CI 0.76, 0.83).iii
“iCAD’s Breast AI Suite offers a complete portfolio of unrivaled
breast cancer detection, density assessment, and short-term risk
evaluation AI solutions, and we are pleased to see this compelling
data further validate the clinical value of ProFound AI Risk, the
latest addition to our breast AI portfolio,” said Stacey Stevens,
President and CEO of iCAD, Inc. “Physicians have traditionally
estimated breast cancer risk by examining the patient’s known risk
factors, such as family history, but about 85% of breast cancers
occur in women who have no family history of breast cancer.iv
Additionally, traditional long-term risk models may not be as
accurate at estimating a woman’s risk of developing breast cancer,
as their average AUC is around 0.60.v ProFound AI Risk offers a
more individualized approach, as it includes a woman’s mammography
images and focuses on one-to-two-years in the future, which
provides critical information that can help clinicians personalize
breast cancer screening regimens for patients based on their
individual risk of developing cancer before or at their next
screening.”
Established lifestyle-familial risk models, such as Tyrer-Cuzick
and Gail, are currently used in the U.S. to identify women with a
greater than 20% lifetime risk of developing breast cancer who
could be offered breast magnetic resonance imaging (MRI) as a
supplemental screening modality for breast cancer detection.i
However, these long-term risk models can result in a high number of
false positives due to low-to-moderate discrimination
performance.vi ProFound AI Risk complements traditional risk models
and is easy for clinicians and medical facilities to adopt, as it
only requires the images from a 2D or 3D mammogram, with no
questionnaires, portals, or staff required to implement.
Using U.S. guidelines, the researchers determined that 14% of
the women studied were at high risk after a negative or benign
screening, with an almost 20-fold higher risk of developing breast
cancer, compared to the general risk population. In this high-risk
group, 76% of stage II or later cancers, 59% of stage 0, and 58% of
stage 1 cancers were observed.
Researchers estimated if the 12% of women at highest risk had
been offered supplemental screening based on the ProFound AI Risk
for DBT model, up to 59% of the cancers could have
potentially been detected, compared to 24% of the cancers
using Tyrer-Cuzick. This corresponds to 2.4 times higher
sensitivity than Tyrer-Cuzick.
“Our research showed that women who ProFound AI Risk determined
to be at high risk were more likely to present with later stage
tumors than early-stage cancers,” according to lead author of the
study, Mikael Eriksson, PhD, Karolinska Institutet. “It is known
that breast cancer survival is four and 12-fold worse for stage II
and III cancers compared to stage 0 and I cancers in the first four
years after diagnosis. Furthermore, the treatment cost for stage II
and III cancers is more than twice that of stage 0 and I cancers in
the first 24 months after diagnosis. ProFound AI Risk offers the
potential to aid radiologists in refining personalizing screening
recommendations and discussing risk with women, which could in turn
influence their screening regimen compliance and potentially lead
to earlier detection, reduced treatment costs and improved
outcomes.”
Researchers also found ProFound AI Risk provided high accuracy
in estimating future risk for invasive and in-situ cancers, screen
detected and interval cancers, and in women with both dense and
non-dense breasts.
“Earlier cancer detection can have a tremendous impact on women,
from treatment to outcomes. And because women are often caretakers,
improving outcomes in women’s health can also have cascading
benefits for children, families, and communities,” added Stevens.
“Only iCAD’s Breast AI suite provides clinicians unprecedented
insights into each patient’s present and future, which offers the
potential to transform the trajectory of a woman’s outcome and
life.”
About iCAD, Inc.
Headquartered in Nashua, NH, iCAD® is a global medical
technology leader providing innovative cancer detection and therapy
solutions. For more information, visit www.icadmed.com.
Forward-Looking StatementsCertain statements
contained in this News Release constitute “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements about the expected
benefits of ProFound AI® Risk, the implications of clinical
studies, the benefits of the Company’s products, external factors
affecting the market for our products, behavior of clients and
prospective clients, and future prospects for the Company’s
technology platforms and products. Such forward-looking statements
involve a number of known and unknown risks, uncertainties and
other factors which may cause the actual results, performance, or
achievements of the Company to be materially different from any
future results, performance, or achievements expressed or implied
by such forward-looking statements. Such factors include, but are
not limited, to the Company’s ability to achieve business and
strategic objectives, the willingness of patients to undergo
mammography screening in light of risks of potential exposure to
Covid-19, whether mammography screening will be treated as an
essential procedure, whether ProFound AI will improve reading
efficiency, improve specificity and sensitivity, reduce false
positives and otherwise prove to be more beneficial for patients
and clinicians, the impact of supply and manufacturing constraints
or difficulties on our ability to fulfill our orders, uncertainty
of future sales levels, to defend itself in litigation matters,
protection of patents and other proprietary rights, product market
acceptance, possible technological obsolescence of products,
increased competition, government regulation, changes in Medicare
or other reimbursement policies, risks relating to our existing and
future debt obligations, competitive factors, the effects of a
decline in the economy or markets served by the Company; and other
risks detailed in the Company’s filings with the Securities and
Exchange Commission. The words “believe,” “demonstrate,” “intend,”
“expect,” “estimate,” “will,” “continue,” “anticipate,” “likely,”
“seek,” and similar expressions identify forward-looking
statements. Readers are cautioned not to place undue reliance on
those forward-looking statements, which speak only as of the date
the statement was made. The Company is under no obligation to
provide any updates to any information contained in this release.
For additional disclosure regarding these and other risks faced by
iCAD, please see the disclosure contained in our public filings
with the Securities and Exchange Commission, available on the
Investors section of our website at http://www.icadmed.com and on
the SEC’s website at http://www.sec.gov.
Media Inquiries:Jessica Burns,
iCAD+1-201-423-4492jburns@icadmed.com
Investor Inquiries:iCAD Investor Relationsir@icadmed.com
i Eriksson, M et al. A risk model for digital breast
tomosynthesis to predict breast cancer and guide clinical care.
Science Translational Medicine. 14 (644). 2022 May 11. Accessed via
https://www.science.org/doi/10.1126/scitranslmed.abn3971.ii
Participating U.S. screening sites: Boca Raton Regional Hospital,
Boca Raton, FL; Elizabeth Wende Breast Care, Rochester, NY;
Larchmont, NJ; Zwanger-Pesiri Radiology, Lindenhurst, NY.iii iCAD
data on file. Variations per vendor and population may occur.
ProFound AI Risk is a clinical decision support tool. Information
is reviewed by the physician. All care decisions are up to
physicians.iv Breastcancer.org. U.S. Breast Cancer Statistics.
Accessed via
https://www.breastcancer.org/symptoms/understand_bc/statistics.v
Eriksson M, Czene K, Strand F et al. Identification of Women at
High Risk of Breast Cancer Who Need Supplemental Screening.
Radiology. 2020 Sept 8. Accessed via
https://doi.org/10.1148/radiol.2020201620.vi M. H. Gail, R. M.
Pfeiffer, Breast cancer risk model requirements for counseling,
prevention, and screening. J. Natl. Cancer Inst. 110, 994–1002
(2018).
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