PreciseDx's AI-Enabled Digital Pathology Is the First Proven to Detect Early-Stage Parkinson's Disease

In a collaboration with The Michael J. Fox Foundation, de novo study finds PreciseDx's technology can accurately diagnose Parkinson's disease in living patients prior to severe onset of symptoms

NEW YORK, April 20, 2022 /PRNewswire/ -- PreciseDx, recently spun out from the Mount Sinai Health System in New York, NY, is the only Cancer Risk Stratification company to provide patient-specific risk information through the analysis of morphology features. The company today announced its AI-enabled digital pathology technology can accurately diagnose Parkinson's disease (PD) in living patients prior to severe onset of symptoms.

Diagnosing Parkinson's disease is challenging at all stages due to variable symptoms, comorbidities, and mimicking conditions, with definitive diagnosis only coming postmortem. This groundbreaking study found that PreciseDx's AI-enabled technology is able to facilitate a conclusive diagnosis of Parkinson's, providing critical information for earlier treatment.

"These findings show the potential for technology to aid in diagnosis of Parkinson's disease," said Jamie Eberling, PhD, Senior Vice President of Research Resources at The Michael J. Fox Foundation for Parkinson's Research (MJFF). "Objective diagnostic tools, especially early in disease, are critical to drive care decisions and to design trials toward better treatments and cures."

MJFF partially funded the AI analysis and sponsored the study that provided the data (the Systemic Synuclein Sampling Study).

The PreciseDx study applied the company's AI algorithms (Morphology Feature Array^™) for the IHC detection of α-synuclein within peripheral nerves of salivary glands [i.e., peripheral Lewy-type synucleinopathy (LTS)], along with quantitative feature extraction using morphology features to accurately distinguish LTS in early-stage Parkinson's disease biopsy specimens based upon expert pathologist annotation of the training samples. Following training, the algorithmic test was validated using a separate set of confirmed biopsy specimens.

PreciseDx's AI Morphology Feature Array was able to detect Parkinson's pathology in image patches from biopsy samples with 99% sensitivity and 99% specificity as compared to expert annotated ground truth. The AI edged out the human pathologist with an accuracy of 0.69 versus 0.64 in the prediction of clinical Parkinson's disease status. 

PreciseDx's MFA approach to feature extraction and analysis enables new algorithms to be developed and validated against clinical endpoints. This is extremely valuable to create new diagnostic tests, accurate and reproducible diagnosis, prognosis, patient selection of therapy for a wide range of conditions.

"Traditionally, pathology grading systems look at a few morphology components to make a diagnosis. Unlike any human-powered grading method, PreciseDx's AI Morphology Feature Array (MFA) can examine thousands of different features and leverage those relationships between them," said John F. Crary, MD-PhD, a Professor in the Departments of Pathology, Neuroscience, and Artificial Intelligence & Human Health at the Icahn School of Medicine at Mount Sinai. "This industry-changing study has shown that we need to revitalize the way we think about pathology and lean into using AI to detect diseases more accurately, such as PD. This enlightens the industry to a direct case study into how computational pathology can truly advance medicine in terms of accurately identifying and detecting diseases."

"We look forward to working with PreciseDx as it explores the potential of utilizing the AI platform in pathology across multiple diseases, including Parkinson's," said Erik Lium, PhD, President, Mount Sinai Innovation Partners and Executive Vice President and Chief Commercial Innovation Officer, Mount Sinai Health System.

The cancer risk stratification technology is based on intellectual property developed by Mount Sinai faculty and licensed to PreciseDx. Mount Sinai and Mount Sinai faculty have a financial interest in PreciseDx. Mount Sinai also has representation on the PreciseDx Board of Directors, which includes Dr. Lium.

To view the full study, visit: https://pubmed.ncbi.nlm.nih.gov/35164870/ 

About PreciseDx
PreciseDx is the only Cancer Risk Stratification company to provide patient-specific risk information through the analysis of morphology features, enabling better and more personalized treatment and outcomes. Clinical teams can rely on PreciseDx for unmatched insights and actionable intelligence in determining the best treatment for each patient. Combining the power of artificial intelligence with its proprietary Morphology Feature Array^™, PreciseDx creates disease-specific assays that deliver new levels of pathology information and insight on each patient's risk profile and likely outcomes to aid in treatment decision-making. To learn more about PreciseDx, visit https://precisedx.ai/

About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. We advance medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,300 primary and specialty care physicians; 13 free-standing joint-venture centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, and Long Island; and more than 30 affiliated community health centers. The Mount Sinai Hospital is ranked in U.S. News & World Report's "Honor Roll" of the top 20 U.S. hospitals and among the top in the nation by specialty: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Urology, and Rehabilitation. Mount Sinai Kravis Children's Hospital is ranked in U.S. News & World Report's "Best Children's Hospitals" among the country's best in four out of 10 pediatric specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked among the Top 20 nationally for ophthalmology. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools," aligned with a U.S. News & World Report "Honor Roll" Hospital, and No. 14 in the nation for National Institutes of Health funding. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and top five globally, and Mount Sinai Morningside as top 20 globally, and "The World's Best Specialized Hospitals" ranks Mount Sinai Heart as No. 1 in New York and No. 4 globally and the Division of Gastroenterology as No. 3 globally. For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.

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SOURCE PreciseDx