Dr. Keri Jon Donaldson

Keri Jon Donaldson, MD
Clinical Pathology
Vice Chair, Laboratory Medicine
Divsion Chief, Clinical Pathology

100 North Academy Avenue
Danville, PA  17822-1920
800-695-6491

Dr. Donaldson has joined Geisinger Medical Laboratories in Danville, Pennsylvania, where he serves as vice chair of laboratory medicine and division chief of clinical pathology. In this role, he is responsible for medical oversight of all clinical pathology services for the Geisinger system, including clinical chemistry, immunology, toxicology, hematology, coagulation, transfusion service, apheresis, stem cell collection, point-of-care testing, flow cytometry, specimen processing, phlebotomy, and customer support.

He is the founder and CEO of SOVLD Health in Carlsbad, California, a company that specializes in designing novel technologies to identify an individual’s risk of disease such as their genetic risk assessment for opioid use disorder. From 2015 until coming to Geisinger, he also worked at Penn State Hershey Medical Center, where he most recently served as the medical director of the Institute for Personalized Medicine Clinical Laboratories.

Education:

Dr. Donaldson received his MD from the Temple University School of Medicine and a master of science in epidemiology degree from Perelman School of Medicine, University of Pennsylvania School of Medicine, both in Philadelphia, Pennsylvania  He completed a residency in clinical pathology and fellowships in transfusion medicine, pharmacoepidemiology and a Pepper fellowship in laboratory medicine (chemistry and coagulation) at the Hospital of the University of Pennsylvania in Philadelphia.  

Dr. Donaldson is board certified in clinical pathology.

Professional Affiliations:

College of American Pathologists
American Association for Clinical Chemistry
Academy of Clinical Laboratory Physicians and Scientists
Association of Clinical Scientists

Research Interests:

Dr. Donaldson's major research interest is the application of predictability modeling on outcomes relative to patient care. Over the previous 10 years, he hasled or been involved in multiple successful efforts for novel test and intervention design at academic institutions, including University of Pennsylvania and Penn State University, as well as private industry at Prescient Medicine/SOLVD Health and Pacific Edge Diagnostics. During this time, he developed the first of its kind polygenetic combinatorial and environmental predictability model for drug response, advance analytical rare event detection algorithms to predict susceptible populations, and multiple factorial disease detection models to identify disease in patients earlier than previously possible. Portions of this work are now incorporated into standard disease screening practice (BRAF mutational testing and urinary tract infection detection), have driven new in vitro diagnostics (urine and coagulation testing), and are used to identify and guide practice at the payer level. The broadened impact of his research and development of new tests will assist in the precision delivery of care in health systems.

Recent Academic Activity

Publications in Peer-Reviewed Journals:

Donaldson K, Cardamone D, Genovese M, Garbely J, Demers L. Clinical performance of a gene-based machine learning classifier in assessing risk of developing OUD in subjects taking oral opioids: a prospective observational study. Ann Clin Lab Sci, 2021;51(4):451-460.

Abstracts, Posters, and Other Presentations:

Toxicology POC Cup discrepancy with Two Different Manufacturers, 4th Annual Addiction Symposium, Hershey, PA. November 28, 2018.

Overview of Development of a Polygenetic Risk Source for OUD, 139th Annual Meeting of the Association of Clinical Scientists, Hotel Hershey, Hershey, PA. May 17, 2019.

Development of a Novel Diagnostic: Concept through Commercialization, 139th Annual Meeting of the Association of Clinical Scientists, Hotel Hershey, Hershey, PA. May 17, 2019.

Automated intelligence algorithms for the JAK-2 testing, 139th Annual Meeting of the Association of Clinical Scientists, Hotel Hershey, PA. May 17, 2019.

Predicting Risk of Opioid Addiction: Evaluation of Genetic Factors Using Machine Learning Algorithms, 2020 Genetics and Epigenetics Cross-Cutting Research Meeting, National
Institute on Drug Abuse (NIDA), January 14, 2020, Rockville, MD.

Late Phase Biomarker Program, Roundtable Lead, Penn State and BMS Research, Penn State Cancer Institute, University Conference Center, Hershey, PA. January 30, 2020.

Identifying sub-populations within OUD cohorts, Presenter, National Institute on Drug Abuse (NIDA) Genetics Consortium Virtual Meeting, July 9, 2020.

Hidden in the Shadows: America’s Opioid Epidemic, Apple Podcast, September 1, 2020.

Management Solutions for Opioid Epidemic Are Similar to Management of the COVID-19 Pandemic, Pharmacy Times, Zoom interview, September 21, 2020.

“The Role of the Clinical Laboratory in Substance Use Treatment and Research”, AACC Annual Scientific Meeting, Virtual, December 15, 2020.

Genetic Risk Assessment to Prevent Opioid Use Disorder (OUD), Center for Substance Abuse Prevention National Advisory Council, Webcast, February 24, 2021.

Genetic Risk Assessment to Prevent Opioid Use Disorder (OUD), Collaborative for Effective Prescription Opioid Policies (CEPOP), Webex, October 25, 2021.

An AI approach to clinical pathology test design, from feasibility to generalizability, Houston Methodist Hospital, Grand Rounds, Webex, November 2, 2021.

How employers can do more for substance use disorder and mental health, Zoom, Milken Institute, Washington, DC, December 6-7, 2021.

Quality Control: What’s Trending and Shifting in QC and IQCP? Webinar, College of American Pathologists, April 20, 2022.

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