ProFound AI Risk Outperforms Traditional, Widely-Accepted Breast Cancer Risk Models for Both Short-term and Long-term Risk Assessments

Rhea-AI Summary

iCAD, Inc. (NASDAQ: ICAD) announced new clinical evidence published in the Journal of Clinical Oncology, demonstrating that ProFound AI Risk for 2D Mammography outperforms the Tyrer-Cuzick v8 risk model for assessing breast cancer risk.

This study analyzed data from 8,604 women over ten years, confirming higher accuracy for ProFound AI Risk across various demographics. The results indicate significant potential for personalized screening regimens and timely cancer detection, enhancing patient outcomes.

iCAD's technology aims to transform breast cancer screening by providing clinicians with improved insights and potentially saving lives through earlier diagnosis.

Positive

• ProFound AI Risk demonstrated superior accuracy in assessing breast cancer risk compared to Tyrer-Cuzick v8.
• Study involved a substantial cohort of 8,604 women over ten years, confirming the model's reliability.
• ProFound AI Risk accommodates all women, irrespective of breast density or family history, enhancing personalized care.

Negative

• None.

ProFound AI Risk offered higher accuracy than Tyrer-Cuzick v8 for all women, regardless of menopausal status, breast density, and family history of breast cancer

NASHUA, N.H., April 04, 2023 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced new clinical evidence published in the Journal of Clinical Oncology found ProFound AI® Risk for 2D Mammography is more accurate than Tyrer-Cuzick v8, a commonly used lifestyle risk model, for both short-term and long-term risk assessments.¹

“The clinical value of ProFound AI Risk is unparalleled, and this exciting research adds to the growing body of evidence that confirms iCAD’s technology is not only more personalized than traditional lifestyle risk models, but also more accurate,” said Dana Brown, President and CEO of iCAD, Inc. “Breast cancer is the most common cancer in women worldwide and the second leading cause of cancer death among women in the U.S., but early detection and diagnosis are a key part of transforming the patient journey and quality of care.^2,3 ProFound AI Risk provides clinicians with superior insights that can empower them to tailor a woman’s breast screening regimen and potentially identify cancers earlier. This is truly game changing technology with life-changing impact.”

Using the unique KARolinska MAmmography Project for Risk Prediction of Breast Cancer (KARMA) screening cohort, researchers compared ProFound AI Risk with Tyrer-Cuzick v8 in a case-cohort study of 8,604 women aged 40-74 years throughout a 10-year follow up. ProFound AI Risk offered higher accuracy than Tyrer-Cuzick v8 for all women – regardless of menopausal status, breast density, and family history of breast cancer – with an area under the curve (AUC) ranging from 0.74-0.65 for ProFound AI Risk, compared to 0.62-0.60 for Tyrer-Cuzick v8.

“This research shows that an image-based risk model can identify high-risk women who may benefit from additional screening or risk reducing intervention. The tool is designed to help clinicians potentially catch cancer sooner, when it is more easily treated or prevented. Both the National Institute for Health and Care Excellence (NICE) and US Preventive Services Task Force (USPSTF) clinical guidelines recommend risk-reducing interventions or more intense screening for women determined to have high risk on the basis of the 10-year or lifetime risk of breast cancer. With ProFound AI Risk, clinicians can now do this with even greater accuracy,” said lead researcher, Mikael Eriksson, PhD, Karolinska Institutet. “It is also worth noting that ProFound AI Risk offered higher accuracy than Tyrer-Cuzick for women with both dense and non-dense breasts. Given that screening sensitivity for women with extremely dense breasts is approximately 50% compared with approximately 90% in women with almost entirely fatty breasts,^4,5 ProFound AI Risk may help clinicians overcome the challenging task of detecting a tumor masked by dense tissue by identifying women who may benefit from supplemental screening following a negative or benign screen.”

iCAD’s Breast AI Suite offers a 360-degree solution of clinically proven cancer detection, density assessment, and risk evaluation technologies. The latest addition to iCAD’s Breast AI Suite, ProFound AI Risk, is the world’s first clinical decision support tool that provides an accurate short-term breast cancer risk estimation that is truly personalized for each woman, based only on her mammogram.^6,7 Available for both 2D and 3D mammography, it uniquely combines age, breast density and subtle mammographic features, offering superior performance and accuracy in assessing short-term risk compared to traditional, commonly-used breast cancer risk models. 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.

“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,⁸” added Ms. Brown. “With ProFound AI Risk, patient care has never been more personalized. By empowering radiologists with more information about a woman’s individual risk, they can tailor breast cancer screening and maximize mammography’s effectiveness, which ultimately leads to finding cancer sooner, reducing costs to the overall healthcare system, and most importantly, saving lives.”

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 Statements                                    
Certain 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 expansion of access to the Company’s products, improvement of performance, acceleration of adoption, expected benefits of ProFound AI®, the benefits of the Company’s products, 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.

Contact:

Media Inquiries:
Jessica Burns, iCAD
+1-201-423-4492
jburns@icadmed.com 

Investor Inquiries:
iCAD Investor Relations
ir@icadmed.com 

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¹ Eriksson M, CzeneK , Vachon C, Conant E, Hall P. Long-Term Performance of an Image-Based Short-Term Risk Model for Breast Cancer. Journal of Clinical Oncology. DOI: 10.1200/JCO.22.01564.
² Arnold M, Morgan E, Rumgay H, Mafra A, Singh D, Laversanne M, et al. Current and future burden of breast cancer: global statistics for 2020 and 2040 Breast, Published online 2 September 2022;
https://doi.org/10.1016/j.breast.2022.08.010.
³ American Cancer Society. Key Statistics for Breast Cancer. Accessed via https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html#:~:text=Breast%20cancer%20is%20the%20second,decline%20of%2043%25%20through%202020.
⁴ Boyd NF, Martin LJ, Yaffe MJ, et al: Mammographic density and breast cancer risk: Current understanding and future prospects. Breast Cancer Res 13:223-312, 2011.
⁵ Huo CW, Chew GL, Britt KL, et al: Mammographic density—A review on the current understanding of its association with breast cancer. Breast Cancer Res Treat 144:479-502, 2014.
⁶ 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.
⁷ 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,
⁸ Breast Cancer Facts and Statistics. Breastcancer.org. Accessed 3/29/23 via https://www.breastcancer.org/facts-statistics.

FAQ

What does the new clinical evidence for iCAD's ProFound AI Risk indicate?

The evidence shows that ProFound AI Risk offers higher accuracy than the Tyrer-Cuzick v8 risk model for breast cancer risk assessment.

How many women were involved in the iCAD study for ProFound AI Risk?

The study included 8,604 women aged 40-74 years over a ten-year follow-up.

What is the significance of the results from iCAD's recent study published in the Journal of Clinical Oncology?

The results indicate that ProFound AI Risk can enhance personalized breast cancer screening and improve early detection rates.

How does ProFound AI Risk differ from traditional breast cancer risk models?

ProFound AI Risk is image-based and requires only mammogram images, providing a more personalized and accurate assessment.

What are the implications of the ProFound AI Risk model for breast cancer screening?

It empowers clinicians to identify high-risk women for additional screening or interventions, potentially leading to earlier cancer detection.