FDA De Novo for QuantX Advanced
Quantitative Insights Gains Industry’s First FDA Clearance for Machine Learning Driven Cancer Diagnosis
CHICAGO, Illinois July 27, 2017 Quantitative Insights, Inc. (QI) today announced that it has received regulatory clearance (via De Novo classification) from the U.S. Food and Drug Administration (FDA) for its QuantX™ Advanced system, the industry’s first computer-aided diagnosis platform incorporating machine learning for the evaluation of breast abnormalities.
“This clearance marks a true breakthrough in the diagnosis and management of cancers, starting with breast,” said Keith Tipton, CEO of Quantitative Insights, “In our FDA clinical study, QuantX was shown to improve the diagnostic performance of radiologists, enabling faster and more accurate diagnosis, more personalized treatments, and better outcomes for patients.”
QuantX™ is a software platform, with advanced analytics and machine learning at its core. Embedded exclusive tools – QI Score™ and Similar Case Database Compare™ – provide similarity assessment to a robust database of abnormalities with clinically documented pathology. This first-of-a-kind system has resulted in a new device Indication for Use via the FDA’s de novo regulatory pathway.
“QuantX provides valuable additional information for multi-modality breast imaging decision support,” states Gillian Newstead, M.D., QI Medical Advisor and former Chief of Breast Imaging at the University of Chicago. “With a single click, we have access to advanced machine learning analytics showing how the abnormality being analyzed compares to similar abnormalities with known pathology. This impacts a radiologist’s confidence and improves reading time, and now we have clinical-study proof that it also significantly improves diagnostic performance.”
QuantX™ incorporates licensed technology from the research labs of Maryellen Giger, Ph.D., Scientific Advisor for the company and professor in Radiology and Medical Physics at The University of Chicago. Giger states, “Quantitative Insights has demonstrated that they can successfully take meaningful clinical innovations from research labs and clinics, develop them into products, take them through the regulatory process, and to the market.” The company has a long-standing collaborative relationship with the university and is supported by the university’s Polsky Center for Entrepreneurship and Innovation.
The company will now pursue its product launch activities in the U.S., which includes expansion of strategic collaborations with clinical researchers. The company is also pursuing distribution partnerships for both the U.S. and international markets. Mr. Tipton concluded, “With QuantX Advanced, we are now ‘all-in’ in the fight against breast cancer.”
About Quantitative Insights
Quantitative Insights (www.quantinsights.com) is dedicated to redefining patient management by harnessing the power of cutting-edge research and advanced quantitative imaging solutions to provide radiologists with intuitive computer-aided decision support tools. The company’s flagship product, QuantX, is a software platform solution for machine learning and deep learning quantitative imaging (or radiomics) solutions. QuantX includes technology licensed from The University of Chicago. The company is supported by the university’s Polsky Center for Entrepreneurship and Innovation.
FDA Clearance of QuantX SE
Quantitative Insights Joins Fight Against Breast Cancer
CHICAGO, Illinois May 19, 2017 Quantitative Insights, Inc. (QI) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its QuantX SE™ system, a quantitative imaging based analysis platform for the evaluation of breast lesions.
“Quantitative Insights is committed to bringing truly disruptive clinical breakthroughs to the fight against breast cancer,” said Keith Tipton, Quantitative Insights’ CEO, “This marks the first of many products to come.”
The company will now pursue product launch activities in the US which include securing several additional Early Adopter sites and pursuing distribution partnerships in the US and select international markets. This groundwork will provide the basis for a major follow-on release of the product which will include advanced machine learning based functionality to further enhance both screening and diagnosis of breast cancer. With the release of QuantX Advanced, expected later this year, the company will launch full scale commercial activities.
“QuantX provides an intuitive, easy to learn and use environment for efficient breast imaging decision support,” commented Gillian Newstead, MD, QI Medical Director and former Chair of Breast Imaging at the University of Chicago. “We’ve waited a long time for a meaningful advancement in breast image analysis. QuantX fills that need.”
Mr. Tipton concluded, “This is one of those defining moments for a young company. We are demonstrating that we can successfully take meaningful clinical innovations from university labs and clinics to the market. Now we will focus on getting QuantX in the hands of clinicians in order to benefit their patients.”
About Quantitative Insights
Quantitative Insights (www.quantinsights.com) is dedicated to redefining patient management by harnessing the power of cutting-edge research and advanced quantitative imaging solutions to provide radiologists with intuitive computer-aided decision support functionality. The company’s first product, QuantX™, is a fully-integrated multi-modality breast imaging software solution, providing advanced analytics on MRI data with simultaneous interactive viewing for all three breast image modalities: MRI, mammography and ultrasound.
Successful FDA Clinical Study
The company announces the successful completion of its pivotal clinical study.
A total of 19 readers completed the study which measured the effectiveness of the QuantX™ system in the task of distinguishing between cancerous and non-cancerous breast lesions. In this study, the QuantX system achieved the primary endpoint of a statistically significant increase in radiologist’s performance. When QuantX was used in image interpretation, AUC increased from 0.7055 to 0.7575 (p=0.0408), compared to interpretation using tools available in existing commercial systems. Mean sensitivity increased from 90.4% to 94.2%.
Performance improved for all of the readers in the study, and very significantly, the study demonstrated a reduction in false negatives (i.e. missed cancers) by 39%.
Each radiologist read 111 retrospectively collected cases in a sequential read protocol. The first read was performed using tools that mimic the tools available on current breast MRI analysis workstations. The case dataset was enriched with cancer cases in order to more effectively measure the performance of the QuantX system.
Reader demographics were well distributed across the key characteristics as follows: eight from academic and eleven from private practice settings, nine with greater than 10 years of breast imaging experience and ten with 10 or fewer, and eight who successfully completed a breast imaging fellowship versus eleven who didn’t. As far as direct breast MRI experience: eight had 5 years or less, seven had 5-10 years’ experience and four had greater than 10 years.
This very successful clinical study result was included in a De Novo 510(k) package and submitted to the FDA for product clearance review.