Research Shows Qlarity Imaging’s Diagnostic AI Technology Improves Radiologist Performance in Differentiating Benign and Malignant MRI Breast Lesions

Top Quote QuantX software increased reader accuracy by 20% for breast MRI interpretation, when compared to conventional computer-aided detection (CAD) software. End Quote
  • Chicago, IL (1888PressRelease) November 13, 2020 - Newly published clinical evidence in Radiology, a journal by the Radiological Society of North America (RSNA), demonstrates the effectiveness of Qlarity Imaging’s QuantX Diagnostic Artificial Intelligence (AI) to distinguish between benign and cancerous lesions on breast MRI exams. In the De Novo clinical trial conducted by researchers from the Department of Radiology at the University of Chicago, which employed a multireader, multicase design, the diagnostic AI software significantly improved the accuracy of 100% of the readers in the study.

    “Many studies have shown the benefits of using dynamic contrast enhanced (DCE) MRI over other imaging modalities in detecting and diagnosing breast cancer, but various factors, including subjective interpretation and complexity of cases, can hinder radiologist performance in evaluating MRI exams,” said Dr. Gillian Newstead, one of the study’s authors and advisor to Qlarity Imaging. “Our goal was to demonstrate how AI can be used as a decision support tool to address challenges with reading breast MRI cases and improve diagnostic accuracy for patients who are anxiously awaiting their results.”

    Setting this study apart from previous evaluations of AI systems, the De Novo trial—in support of the first diagnostic AI software approved by the U.S. Food and Drug Administration (FDA)—used a large sample of readers from varying key demographic backgrounds and an enriched dataset, including a mix of lesion types, that was analyzed in a sequential-read protocol. The first read was performed using tools that mimic those available on current breast MRI CAD workstations. The second-read condition featured diagnostic AI insights from QuantX.

    Serving as the primary measurement of accuracy, the average area under the receiver operating characteristic curve (AUC) increased more than 20%, from 0.71 to 0.76 (p=0.05), with the concurrent introduction of the AI system. In addition to improving overall clinical accuracy, the mean sensitivity increased from 90.4% to 94.2% without a statistically significant decrease in specificity and false negatives, i.e. missed cancers, decreased by 39%.

    “The findings from this study reinforce our vision of transforming breast imaging with AI technology, starting with our diagnostic AI solution for breast MRI,” said Jon DeVries, chief executive officer of Qlarity Imaging. “By helping radiologists gain clinical clarity, we aim to enhance diagnostic performance and ultimately improve the quality of care for patients in need.”

    Furthering its dedication to working with radiologists to enhance patient care, Qlarity Imaging is a sponsor and exhibitor at RSNA’s Annual Meeting, which is taking place online from November 29 to December 5. Visit the company’s virtual booth to connect with team members via live chat, schedule a meeting, and watch Dr. Newstead demonstrate how a radiologist can use QuantX in a clinical setting. Learn more:

    To view an abstract of the study and download the article in Radiology by Jiang et al, “Artificial Intelligence Applied to Breast MRI for Improved Diagnosis,” visit

    Indication: QuantX is indicated for the assessment and characterization of breast abnormalities from MRI data in patients presenting for high-risk screening, diagnostic imaging workup, or evaluation of extent of known disease. QuantX is not intended for primary interpretation of digital mammography images.

    Risk Information: QuantX is not intended for primary interpretation of digital mammography images. Labeling also provides information to users about potential limitations of the device related to specific subpopulations. For use by licensed healthcare professionals only.

    About Qlarity Imaging
    Qlarity Imaging assists radiologists in diagnosing breast abnormalities with AI-driven technology that enhances clinical insights. Using quantitative analysis to improve decision making, we provide value to radiologists, health systems, and most importantly patients. Qlarity’s award-winning initial product, QuantX, is the first computer-aided diagnosis software to be cleared by the FDA for breast MRI evaluation. Qlarity Imaging was founded by Paragon Biosciences, a life science innovator that creates, invests in and builds life science companies in artificial intelligence, cell and gene therapy, synthetic biology, and biopharmaceuticals. For more information, please visit

    About Paragon Biosciences
    Qlarity Imaging is a portfolio company of Paragon Biosciences. Paragon is a life science innovator that creates, invests in and builds life science companies in artificial intelligence, cell and gene therapy, synthetic biology and biopharmaceuticals. Our current portfolio includes Castle Creek Biosciences, CiRC Biosciences, Emalex Biosciences, Evozyne, Harmony Biosciences, Qlarity Imaging, Skyline Biosciences, and a consistent flow of incubating companies created and supported by our replicable Paragon Innovation Capital™ model. Paragon stands at the intersection of human need, life science, and company creation. For more information, please visit

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