Jon T. DeVries, Chief Executive Officer, Qlarity Imaging
Breast cancer remains the second leading cause of cancer deaths in women, impacting more than 2.1 million women annually according to the World Health Organization (WHO). Early detection combined with accurate diagnosis are critical to surviving this devastating disease. The sensitivity of breast MRI makes it an effective diagnostic tool and screening technique in high-risk patients. However, overwhelming study data and subjective interpretation make breast MRI evaluation one of the more challenging exams for radiologists.
Qlarity Imaging is on a mission to help radiologists overcome challenges with breast MRI exams by enhancing diagnostic insights through AI-enabled tools, ultimately leading to better patient care. In 2019, the company introduced QuantX—the first FDA-cleared computer-aided diagnosis (CADx) software for the evaluation of breast MRI. The De Novo clinical trial, required for FDA approval, showed QuantX reduced missed cancers by 39 percent and improved overall diagnostic accuracy by 20 percent. “When using QuantX, we were thrilled to see that all of the radiologists in the trial improved their diagnostic performance,” says Jon T. DeVries, Chief Executive Officer at Qlarity Imaging.
The heart of the software is the QuantX Score, a single numeric value generated by a proprietary AI algorithm. The algorithm synthesizes 34 radiomic features pertaining to a segmented lesion, such as size, shape, contrast, surface, and location, to generate the QuantX Score. This data-driven analysis helps radiologists differentiate between a benign and malignant lesion. While other software tools help strictly with the detection of abnormalities, QuantX helps radiologists diagnose malignancy.
“Instead of being a black box where the radiologist does not see how the software makes decisions, the QuantX score allows the radiologist to understand how the results are obtained and make a more informed decision,” explains DeVries.
QuantX streamlines a radiologist’s workflow through several automated processes. The software integrates data from different modalities into a single image viewer, and segments and analyzes lesions with one click to generate a 3-D outline, providing volumetric and surface area analysis of the user-selected regions of interest. In the future, QuantX will launch directly from PACS, export the results directly into the reporting application, and archive the findings back to PACS. QuantX also includes an easy-to-use, vendor-neutral MR-guided biopsy module for lesion biopsy.
Instead of being a black box, QuantX analyzes images on 34 clinically validated metrics, allowing radiologists to understand how results are obtained
The software identifies where the malignancy is, how and where the needle should be inserted, and how deep the needle should go—aiding radiologists performing biopsy procedures.
Qlarity Imaging employs a client-centric process in implementing QuantX to help radiologists effectively and efficiently leverage the software for breast cancer detection and diagnosis. DeVries shared a customer success story of a community hospital that has a mixture of fellowship-trained breast radiologists and diagnostic radiologists to read breast MRI data. “Our software is helping radiologists be more confident in completing the diagnostics process, allowing the community hospital to expand its breast imaging practice at their facility,” says DeVries. The company installed QuantX in two days and trained the hospital’s resources in a day to ensure timely and effective implementation. Also, acknowledging the need to work remotely amid the COVID-19 pandemic, the company offers virtual demonstrations, remote software installation and online training.
Qlarity Imaging is a portfolio company of 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. Rooted in years of research, the technology underlying QuantX was invented at The University of Chicago. For its innovative product, Qlarity Imaging has won awards and recognition that include the 2020 Gold Edison Award and a 2019 Best Invention from Time Magazine.
“QuantX is just the beginning. We are planning to expand our services to multiple modalities covering all of Women’s Imaging and develop deep expertise in this therapeutic area, positioning us as a leader in the transformation of breast imaging,” concludes DeVries.
Indication: QuantX is indicated for evaluation of 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.
Important Safety Statement: QuantX is not intended for primary interpretation of digital mammography images. Warnings and cautions related to the potential device failure or low performance are included in the User Manual including comments on image quality, patient population, and segmentation accuracy. Warnings and cautions related to the device are included in the User Manual. Information about the Similar Case Database and cases used in the MRMC study provided in labeling also provide information to users about potential limitations of the device related to specific subpopulations.