March 3, 2025—The Diagnostic Medicine Consortium has officially launched, bringing together the Association for Pathology Informatics and Project Santa Fe Foundation, with the aim of adding other like-minded collaborating medical diagnostic societies. The consortium is committed to maximizing and standardizing the predictive value of actionable information generated by the diagnostic sector, so as to promote the proactive delivery of health care for individuals and populations. The goal is to shift from traditional reactive confirmation of disease conditions to proactive identification of risk for disease onset, while promoting a comprehensive approach to longitudinal chronic disease management. The DMC will also address maximizing the use of diagnostic information during episodes of acute illnesses.
At the core of the DMC’s mission is the development of a standardized approach to creating deidentified, harmonized data repositories that can serve as a comprehensive “data vault.” This critical resource will enable optimization of reference standards for population cohorts and facilitate training of artificial intelligence diagnostic algorithms. By validating the algorithms, the DMC will establish itself as a pivotal entity for submitting 510(k) applications to the FDA, creating essential pathways for product development of risk-based health care strategies that benefit patients at the individual level.
“Potential value emerges when pathology and the clinical lab’s role is extended beyond result release as the completion of service delivery. The release of diagnostic information is where patient care truly begins,” Khosrow Shotorbani, CEO of Project Santa Fe Foundation–Clinical Lab 2.0 Movement, said in a statement. “Pathology and the clinical laboratory must then provide leadership in ensuring that this information is used to maximal benefit in care of the individual patient and the population the laboratory serves. This necessitates development not just of enabling technologies, which is well underway, but to having the appropriate reference populations to validate predictive algorithms for those populations. Our consortium is established to address this gap and to develop a sustainable business model for doing so.”
“These two organizations aim to leverage our collective expertise in the data science of medicine and our strong leadership in education, standardization, and discovery,” James Crawford, MD, PhD, professor and chair emeritus, Department of Pathology and Laboratory Medicine, Northwell Health, said in the statement. “In bringing forward a unique resource for understanding the variability of human populations, artificial intelligence algorithms can be validated that will appropriately inform clinical decision-making.”
“It has long been time for pathologists to escape the confines of their offices and laboratories and take a more active role in the diagnosis and treatment of their patients,” said Ron Jackups Jr., MD, PhD, professor of pathology and immunology at Washington University School of Medicine. “The Diagnostic Medicine Consortium will drive the optimization of clinical decision-making through laboratory testing and equip pathologists to form diagnostic partnerships with front-line health care providers.”
The DMC is a global-centric movement for defining the future state of pathology and laboratory-based diagnostics. “We have a perfect storm of opportunity, as our organizations lie at the nucleating point of the academic, community, and industry sectors of our diagnostic specialty,” said Ulysses G. J. Balis, MD, A. James French professor of pathology informatics at the University of Michigan. “By addressing both result reference intervals for diverse populations and having a deidentified central data repository, it becomes possible to validate artificial intelligence algorithms in a truly generalizable sense. With these broadly sourced and curated sets of primary diagnostic data, AI tools can be built that perform reliably for all locales and populations, including those in low- and middle-income country settings. These validated data sets can and will be made freely available on a global basis. This knowledge can then be brought back to the individual patient to benefit their care.”
The DMC has established a set of critical objectives to realize this transformative vision:
- Unified advocacy for the essential role of pathology and laboratory medicine in the era of diagnostic data intelligence.
- Impactful program development that promotes proactive prediction of disease onset and evolution.
- Strengthened collaborations among member organizations to achieve a global reach.
- Engage key stakeholders, including public health authorities, health care stakeholders, and industry partners to align strategies for advancing diagnostic medicine.
- Secure sustainable business models to support the consortium’s mission.
Key deliverables of the DMC include the following:
Data resource: A deidentified, harmonized repository for optimizing reference standards and training AI algorithms, qualifying for FDA 510(k) submissions as part of the product development pipeline.
Data intelligence network: A seamless platform for data sharing and querying to enhance diagnostic capabilities for individual patients across their health care continuum.
Educational programs: Developing training and outreach initiatives to disseminate knowledge about predictive analytics and best practices, along with academic education for future pathology and clinical laboratory science in the concept of diagnostic health.
The Diagnostic Medicine Consortium embodies a steadfast commitment to innovation, prioritizing prevention and early intervention. By leveraging the power of longitudinal data, the DMC is poised to pave the way for a more integrated and effective health care system that enhances patient health outcomes.