PhD, MD Chief Medical Officer & Laboratory Director, Renalytix Professor of Experimental Pathology & Director of Biorepository and Pathology at the Icahn School of Medicine at Mount Sinai, NYC
Responsible for overseeing the daily clinical laboratory operations and ensuring all patients receive the highest-quality medical care
Board certified, anatomic, clinical and pediatric pathology
20-years of experience in the biotechnology industry in various senior management roles, including at Millenium Pharmaceuticals and Incyte Pharmaceuticals
Chief Medical Officer at various life sciences companies: PreciseDx, VericiDx, Aureon Biosciences, MetaStat Inc., Exosome Diagnostics, Inc, Vigilant Biosciences
Spearheaded the utilization of multiple tissue and fluid-based assays and coupled mathematical applications to produce clinically relevant diagnostic/prognostic outcome models for a variety of disease states
Extensive experience in designing/implementing clinical studies for various disease states
Academic Career: Harvard Medical School and Boston Children’s Hospital, Professor of Pathology at Icahn School of Medicine, Mount Sinai NYC and Vice-Chair of Translational Research & Professor of Pathology, University of Miami
BS, Zoology: Rutgers University
MD: University of Medicine & Dentistry of New Jersey
Master of Science, Endocrinology: Rutgers University
PHD, Cell & Developmental Biology: Rutgers University
Post-Doctoral studies: Harvard Medical School
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Responsible for overseeing the day-to-day operations across all KidneyIntelX labs and the program management team, ensuring efficient and effective processes, and driving strategic initiatives to achieve our business objectives.
17-years of experience in the clinical diagnostic setting, leading teams from development through commercialization of LDT and FDA products.
Responsible for ensuring compliance with U.S. and international Quality Management System regulations and standards and driving efficient FDA and EMA approvals for a series of products under the KidneyIntelX portfolio brand
24-years of experience in senior Quality & Regulatory leadership roles
Head of Quality Assurance, Abbott Molecular Diagnostics
Global Vice President, Quality Assurance & Regulatory Affairs, CareFusion
BS, Biological Science: University of Texas, El Paso
Certifications: Lean Six Sigma Black Belt
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Director of Quality, Laboratory Controls
Responsible for Quality Control procedures and processes for all clinical laboratories. Ensures full compliance with CLIA and FDA regulations, CAP and ISO standards and New York State Department of Health requirements.
20-years of experience in the clinical laboratory field
10-years of experience in clinical laboratory compliance
CLIA Program Manager, State of Utah; brings extensive laboratory auditing and assistance in ensuring laboratories achieve compliance
Manager, Utah Department of Public Health
Variety of clinical laboratory and compliance roles, ARUP Laboratories
Public health reporting
Laboratory compliance and management
Internal/external regulatory audits
BS, Medical Laboratory Science: University of Utah
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If you need additional assistance, contact our Client Services Team at 888.203.2725.
If you have any questions, call our Patient Support Team at 844.870.8870.
KidneyIntelX is a Laboratory Developed Test (LDT) that yields a custom risk score identifying adult patients with type 2 diabetes and chronic kidney disease stages 1-3, who are at low, intermediate or high risk for rapid disease progression within a period of up to five years. It is regulated by the Centers for Medicare and Medicaid Services (CMS) in CLIA-certified laboratories. The KidneyIntelX test is currently used for clinical and commercial purposes; It should not be regarded as only investigational or for research purposes.