Our Laboratory & Quality teams:

unmatched in the industry.

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 Professor of Pathology at Icahn School of Medicine, Mount Sinai NYC
• Education:
  • 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

Head of Clinical Laboratory Operations

• Responsible for clinical laboratory operation activities across all KidneyIntelX labs
• Held various leadership roles at Quest Diagnostics, a worldwide provider of IVD diagnostics
• Held science and technical operation roles, ARUP Laboratories and Labcorp
• Education:
  • BS, Clinical Lab Science; University of Nebraska Medical Center
  • MBA: University of Utah, David Eccles School of Business
• Certifications: Six Sigma, ASCP

Vice President, Quality Assurance & Regulatory Affairs

• 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
  • Worldwide Vice President, Quality Assurance & Regulatory Affairs, Becton Dickinson
  • Global Vice President, Quality Assurance & Regulatory Affairs, CareFusion
• Education:
  • BS, Biological Science: University of Texas, El Paso
• Certifications: Lean Six Sigma Black Belt

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
• Specialties:
  • Public health reporting
  • Laboratory compliance and management
  • Internal/external regulatory audits
  • Technical/SOP writing
• Education:
  • BS, Biological Science: University of Texas, El Paso
• Certifications: ASCP