global provider of customized laboratory and research services

Biopharma & Pharma

Biomarker and Companion Diagnostic Development – Bench to Bedside

The promise of personalized medicine is quickly being realized, as the pharma industry increasingly turns its focus to discovering and delivering targeted, personalized therapeutics. Biomarkers and companion diagnostics are at the core of this capability. MSS is a leading centre for the development and delivery of pharmacogenomics assays and companion diagnostics, clearly differentiated from traditional CRO’s.

We provide flexible integrated, comprehensive services to (Bio)Pharma companies seeking to develop Biomarkers or Companion Diagnostics in support of their Therapeutic program. We provide unbiased pragmatic guidance and expert support from initial Biomarker assay concepts and discovery right through to regulatory submission and commercialization, or any part therein.

Bench to Bedside

Pharmaceutical and biotechnology companies rely on rapid and accurate selection of biomarker signatures to bring clinically relevant biomarkers to patients. With significant experience in assay development and validation, Mount Sinai Services expertise allows its pharmaceutical partners to optimize their designs and reduce costs while accelerating timelines.

  • Design flexible and efficient strategies for identification and development of biomarkers that mitigate downstream risk
  • Proven scientific know-how to develop clinically robust assays
  • Experts in designing the right test for the right application
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.

Biomarker & Assay Development

Engaging Mount Sinai Services early in the biomarker discovery and development process helps to mitigate risks and achieve higher efficiencies. With significant experience in diagnostic kit development and commercialization, we enable our partners to optimize their assay designs and successfully convert biomarker signatures into robust tests. Our development process is guided by intended use, with flexibility to accommodate a range of assay development complexity. We can do direct assay transfer or full development starting with sample procurement and biomarker discovery through clinical validation.
MSS offer a full suite of biomarker development and assay validation services to ensure our clients develop clinically relevant tests and show drug effectiveness. We have flexibility to develop Research Use Only (RUO) and Investigational Use Only (IUO) assays, CLIA-based tests, and In Vitro Diagnostic kits for Premarket Approval (PMA).

Validation

Mount Sinai Services offers clinical testing for both prospective and retrospective studies. Our dedicated staff brings experience and the technical resources needed to successfully support and streamline your clinical trials. Our Clinical laboratory is CAP-accredited, ISO 15189 and GCLP-compliant. We offer flexible, platform-agnostic testing programs and the ability to validate standard assays and custom developed biomarkers. We have extensive clinical trial experience and commercialization of our own Laboratory Developed Tests (LDTs). 

Clinical Trials & Health Technology Assessment

The MSS approach is collaborative and scientifically rigorous. We work closely with our clients to carefully collect, evaluate and report the data required to support specific goals. Our unique relationship with Mount Sinai Hospital provides exceptional opportunities to streamline the clinical trials process and benefit from access to world-renowned clinical expertise.

Achievement of market adoption and reimbursement of Life Science innovation is increasingly dependent on completion of effective Health Technology assessments (HTA).   MSS can work with you to cost-effectively design and implement protocols for health economic and clinical utility evaluation.

MSS offers:

  • A centralized solution for testing in all phases of clinical development to support randomization or enrichment of patient populations
  • Extensive experience with diagnostic FDA (PMA) & Health Canada trials for the companion diagnostic
  • A diverse, centralized patient population for streamlined recruitment
  • Access to clinical specimens for retrospective and prospective studies
  • Coordination of sample collection and testing from single or multiple clinical sites
  • State-of-the-art “gold standard” predicate assay platforms for demonstration of equivalence

Regulatory Approval

Mount Sinai Services understands that early strategic regulatory planning is essential to ensure a seamless process from development and validation to commercialization.  Our regulatory team is engaged early to understand the “Intended Use” of the test, which drives the development and regulatory processes.  MSS has extensive experience supporting our clients throughout clinical validation, regulatory approvals and IP protection processes in Canada and the USA.
  • GCLP-compliant laboratories
  • Design and management of clinical trials
  • Experience assembling FDA / Health Canada/international documentation
  • Experience with LDT, IVD, PMA and 510(k)
  • Experience with patent submissions

Market Adoption

Because of our unique partnership with Mount Sinai Hospital’s diagnostic laboratories, MSS can facilitate the translation from assay validation to patient care.

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 ISO and CAP accredited clinical diagnostic laboratories.

  • MSS’ relationships and collaboration with world renowned clinicians, researchers and key opinion leaders can help successfully launch new innovations into the health care market
  • MSS can support clients seeking to have new tests qualify for government reimbursement with consultation services and clinical trials designed to demonstrate clinical utility and health economic value
  • Our partnership with the Pathology and Laboratory Medicine group facilitates platform validation and test services by this world-class team

market partners

MSS as Market Partners

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 ISO and CAP accredited 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.