global provider of customized laboratory and research services

Diagnostics/Medical Devices

Bench to Bedside Development Services for Clinical Insight, Access and Impact

Bringing a new point of care device or in vitro diagnostic assay to market is challenging. MSS has the expertise and pragmatic insight to help you reach your key milestones with specialized capabilities differentiated from traditional CRO’s.

Our purpose is to provide flexible integrated services from initial assay concepts and validation through to clinical trials, technology assessment, regulatory approval and commercialization. We provide independent and unbiased guidance, expert analysis and the seamless integration of services you need to develop a diagnostic product.

Bench to Bedside Development Services

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 execution of projects effectively, efficiently and with high quality performance.

Broad Development Capabilities: We have expertise for Point of Care (POC), Multiplex Assay and Medical Diagnostic platforms. Our capabilities include a variety of approaches including IHC, Flow Cytometry, quantitative RT-PCR, array CGH, and Next-Gen sequencing technologies. We provide the technology options best suited to meet the needs for biomarker detection/quantification.

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.

Biomarker Discovery & Assay Development

Mount Sinai Services has strong competency in biomarker discovery through an unparalleled compliment of capabilities and platforms and access to clinical specimens for retrospective and prospective studies. We provide exceptional access to technical expertise and can focus development efforts in the most clinically meaningful directions. We have extensive experience with assay development for tissue, cell and fluid-based biomarkers using GCLP and non-GCLP environments. Our capabilities include: cell biology, Biochemistry, Immunology, Microbiology, Molecular biology and Genomics. We offer a diverse array of state-of-the-art instrumentation and diagnostic platforms including:

  • Real-time Quantitative PCR
  • FISH
  • Conventional and Next Generation Sequencing
  • Multiplex Immunoassay Platforms
  • Array-based platforms for genotyping and methylation analysis
  • Advanced bioimaging (confocal, SEM, TEM and scanning probe microscopy)

Specialists in Diagnostics Validation Studies

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 medical devices, laboratory methods and diagnostic assays.

We routinely conduct validation studies on new assays in development as well as commercially available kits (RUO). Our team works with clients in a truly collaborative fashion, using state-of-the-art tools to support development at every stage. Whether the goal is to support a regulatory submission, to collect data for a scientific publication, or to demonstrate clinical utility to drive adoption and reimbursement decisions, MSS can work with you to cost-effectively design and implement a research or clinical trial strategy that will meet your business needs.

Clinical Trials and Health Technology Assessment

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

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 and other academic/healthcare centers provide exceptional opportunities to streamline the clinical trial process and benefit from access to world-renowned clinical expertise. MSS offers:

  • Extensive experience with FDA and Health Canada requirements
  • 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
  • User testing with doctors, nurses, technicians and patients in real and simulated settings

Regulatory Support

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 documentation
  • Experience with LDT and IVD
  • Experience with patent submissions

Commercialization

Because of our unique partnership with Mount Sinai Hospital and other academic/healthcare diagnostic laboratories, MSS can facilitate the translation from device and assay validation to market adoption.

  • 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 groups facilitate platform validation and test services by this world-class team.