global provider of customized laboratory and research services

Method Development & Validation Services

MOUNT SINAI SERVICES has extensive experience with method development, validation studies and clinical trials for biomarker assays, in vitro diagnostics and point of care testing devices.

Our R&D team can assist with validation and verification studies to demonstrate the performance characteristics as well as the clinical utility of new diagnostics, laboratory methods and assays.

We routinely conduct validation studies on research assays in development as well as commercially available kits. The team works with clients in a truly collaborative fashion, using state-of-the-art tools to support development at every stage. MSS has specialized expertise in the discovery, development and validation of prognostic, diagnostic and theranostic biomarker assays. MSS can work with you to cost-effectively design and implement a research or clinical trial strategy that will meet your business needs.

  • Experience with FDA and Health Canada regulatory requirements for LDTs and IVDs
  • Conventional and multiplex immunoassays (chip- and bead-based)
  • Histopathological markers (FISH, IHC)
  • Genetic markers (PCR, microarrays, conventional and next-gen sequencing)
  • Point of Care applications

Robust Quality System Foundation: We provide flexible R&D capabilities within a clinical diagnostic quality system. Our proven tailored approach ensures all operations meet current industry standards and FDA/Health Canada/International regulations.

Efficient Step-by-Step Development: From concept through to completion your project is rigorously planned with the clinical end goal in mind. Our unique access to samples, patients, and clinicians enables efficient development.  Our scientific, clinical and regulatory experts are focused on timely, quality design and execution.

Bridging the Gap- Connecting Developers with Opportunities: Our unique integration into Mount Sinai Hospital and other leading health/research institutions facilitates innovation evaluation and adoption into patient care.

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