global provider of customized laboratory and research services

Personalized Medicine Development & Testing Services

Mount Sinai Services is a leading centre for the development and delivery of pharmacogenomics assays and companion diagnostics.

Personalized medicine helps determine an individual’s predisposition to a particular disease or condition, and allows physicians to prescribe individualized and efficient treatments based on each patient’s genetic profiles, increasing the effectiveness of treatment while reducing the risk of adverse side effects.

MOUNT SINAI SERVICES is a leading centre for the development and delivery of pharmacogenomic assays and companion diagnostics in this emerging field.

Bench-to-Bedside Development Services

MSS has specialized expertise in the discovery, development and validation of prognostic, diagnostic and theranostic biomarker assays.

  • Experienced partner for clinical validation studies
  • Companion Diagnostic development from proof of concept to pivotal trials
  • GCLP-compliant support for FDA & Health Canada regulatory submissions (LDTs and IVDs)
  • Conventional and multiplex immunoassays (chip- and bead-based)
  • Histopathological markers (FISH, IHC)
  • Genetic markers (PCR, microarrays, conventional and next-gen sequencing)
  • Close connections to world-leading experts in personalized health care and diagnostic innovation

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Molecular Diagnostic Testing Services

MSS is an experienced partner in the commercialization and launch of molecular and companion diagnostic assays. We offer a range of advanced molecular tests through our GCLP-compliant clinical diagnostic laboratories:

  • First in Canada to offer the KRAS companion diagnostic assay for patients with colorectal cancer.
  • First in Canada to offer aCGH Preimplantation Genetic Screening to support in vitro fertilization.
  • MSS provides access to one of only two reference centres for HER2/neu testing in Ontario, which helps determine the best course of therapy for patients with breast cancer.

MSS’ offering of pharmacogenomic and companion diagnostic assays will continue to expand across a wide range of therapeutic areas.

Case Study: Validation and Launch of a Companion Diagnostic Assay