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Breakthrough Radiomic Technology Patent Issued to Imaging Endpoints

Imaging Endpoints announced today that the U.S. Patent and Trademark Office has issued Patent No. 10,332,634 – “Systems And Methods For Reliably Diagnosing Breast Cancer Using Quantitative Textural Analysis” to Imaging Endpoints’ and its inventor, Chief Medical Officer, Ron Korn, M.D., PhD.

This breakthrough radiomic evaluation tool allows for rapid diagnosis of the nature of a patient’s breast abnormalities from standard mammography images. The technology enables a real-time evaluation that is otherwise available only through an invasive biopsy and avoids the time involved in obtaining and processing the biopsied tissue. Imaging Endpoints is honored and excited to share with the market this patented technology that could provide patients and physicians the advantage of faster, less invasive information that is critical to treatment decisions and patient outcomes.

Imaging Endpoints is a pioneer and global leader in the non-invasive interrogation of tumors and diseased tissues by analyzing diagnostic images to identify imaging patterns linked to tumor biology. In cancer patients, image analysis provides a non-invasive, low-risk approach to assessing tumor biology prior to therapy and an objective pathway for monitoring treatment responses. The method of using signals detected on image data to characterize tumor biology is based on underlying tumor biology, growth kinetics and other drivers of oncologic transformation which may have novel expression patterns on standard of care radiological images. When used alone or in combination with other factors, a unique imaging phenotype may be developed to characterize lesions using both qualitative and quantitative approaches. Thus insights into the biologic processes of tumors may be measured, derived, inferred or predicted with the discovery of imaging phenotypes. This coupled with imaging’s ability to provide a comprehensive and real-time assessment of the entire tumor and its micro-environment make quantitative imaging an attractive tool for rapid assessment and prognosis.

The Breast Imaging Reporting and Data System (BI-RADS) was established by the American College of Radiology to assign mammogram screenings into discrete categories of perceived severity. A follow-up biopsy is typically recommended for BI-RADS category 4 and higher. However, biopsies ultimately confirm that many BI-RADS 4 designations are benign. Consequently, many women undergo painful and expensive biopsies only to find that the tumor is benign due to the rate of false positives.

Ronald Korn, MD, PhD commented: “A reliable imaging signature for differentiating between malignant and non-malignant BI-RADS 4 mammographic lesions has remained elusive until now. The Imaging Endpoints’ invention provides a biomarker signature for determining whether a lesion identified in a breast image is malignant. The signature is derived from processing mammography data using a Quantitative Textural Analysis™ platform (TexRAD); generating respective histograms and related quantitative metrics, and performing logistical regression to yield a model predictive signature. Imaging Endpoints believes that its technology offers a real-time advantage with rapid results, however additional studies are needed to further validate the correlation of the signature with pathologic variables.”

Imaging Endpoints currently offers imaging CRO services for the use of its advanced imaging technologies in clinical trials, and is actively seeking partners to commercialize its technologies for routine patient care.

About Imaging Endpoints:

Imaging Endpoints (IE) is an imaging research and core laboratory that provides comprehensive imaging CRO (iCRO) services and technology solutions throughout the clinical trial process. IE is one of the largest iCROs globally and is widely recognized for conducting the industry’s most complex imaging trials.

IE’s iCRO experience spans hundreds of successful trials across all phases of development, including some of the most high-profile, global registration trials in the industry. In addition to its core services, IE accelerates product development by integrating new, more powerful imaging technologies into clinical trials such as radiomics and artificial intelligence where peer-reviewed publications have established the company as the industry leader.

Imaging Endpoints is based in Scottsdale, Ariz., with an East Coast office in Waltham, Mass. IE is an affiliate of HonorHealth, one of the largest healthcare systems nationally, and an affiliate of Southwest Medical Imaging, Ltd. (SMIL/RadPharm), part of the largest private radiology group in the U.S.

For more information, contact Ryan Litner at or 480.314.3070.

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