Method Development and Validation Services
MOUNT SINAI SERVICES has extensive experience with development and validation projects of all kinds. Our R&D team works with our clients in a truly collaborative fashion to support the clinical validation of new technologies, using state-of-the-art tools to support development from proof-of-concept through to regulatory approval and production.
Biomarkers and Assay Development
MSS specializes in the development of new assays as well as the refinement of existing methods, utilizing a broad range of advanced analytical platforms to achieve the highest possible sensitivity and specificity. We have extensive experience with tissue-, cell-, and fluid-based biomarker assay development in GLP and non-GLP environments. Our capabilities include:
- Biomarker discovery
- Cell biology
- Biochemistry
- Immunology
- Microbiology
- Molecular biology
- Genomics
Technology Platforms
MSS has access to 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)
Analytical and Clinical Validation
MSS has extensive experience in conducting studies to demonstrate the analytical validity of laboratory methods and assays. We routinely conduct full, partial, cross and transfer validations on laboratory-developed tests as well as commercially available kits.
MSS also offers expertise in clinical validation, and can design and manage clinical trials required to demonstrate clinical outcomes. Our close connection to Mount Sinai Hospital can catalyze access to documented clinical samples and facilitate partnership with key opinion leaders. We can easily develop new assays or validate existing assays for use in clinical trials, and are experienced in supporting the development of companion diagnostics.
Validation protocols are developed to best fit the type and intended use of a given assay, and are compliant with current regulatory guidances and industry best practices.
Regulatory Support
MSS has extensive experience supporting our clients throughout clinical validation, regulatory approvals and IP protection processes in Canada and the USA.
- GLP-certified laboratories
- Design and management of clinical trials
- Experience assembling FDA / Health Canada documentation
- Experience with LDT, IVD, PMA and 510(k)
- Experience with patent submissions
Preparing for Market
Because of our unique partnership with Mount Sinai Hospital’s diagnostic laboratories, MSS can facilitate the translation from device and assay validation to patient care.
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MSS’ relationships and collaboration with world renowned clinicians, researchers and key opinion leaders can help successfully launch new innovations into the health care market
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MSS can support clients seeking to have new tests qualify for government reimbursement
Case Studies
MSS has proven success helping our industry partners to develop, validate and launch new medical technologies. We have worked with medical device and diagnostics companies of all sizes to develop new innovations, and help bring them to market. Our experience has included:
- Point-of-care diagnostic devices
- Multiplex array platforms
- Genetic screening tests
- Molecular diagnostic assays
- Hardware and software validation
We invite you to learn more about our experience.