Case Studies

MSS has proven success helping our clients in the development, validation and launch of innovative medical technologies. The following selection of case studies from more than 10 years of experience is intended to provide an overview of what MSS can offer:

Validation of a Multiplex Biomarker Assay Platform
Validation of a Point of Care Blood Analysis System
Validation and Launch of a Companion Diagnostic Assay

1. Validation of a Multiplex Biomarker Assay Platform

Our client was a medical systems company that had developed an advanced technology for miniaturized, multiplexed biomarker assays for a variety of autoimmune indications. They needed help to validate their assay and platform and obtain FDA approval.

While working with the technology, our technologists identified issues that we knew would limit its adoption in the marketplace if they were not addressed. MSS worked with the product development team to design and implement significant improvements to the platform design.

Analytical and Clinical Validation

MSS conducted an analytical validation in our GLP labs to document assay performance characteristics
MSS designed and managed a clinical trial for the assay, working closely with clinicians at Mount Sinai Hospital’s Rebecca MacDonald Centre for Arthritis and Autoimmune Disease:
- Developed a clinical trial protocol
- Managed REB submission
- Collected and tested clinical samples from 150 patients
- Developed regulatory submission packages for FDA (510[k]) and Health Canada.

Outcome: The platform and the assay were cleared by both Health Canada and the FDA, allowing the company to lead the market with the first multiplexed assay of its kind available in North America.

Product Design and Development

The initial product design took up too much valuable lab space, had complex controls, and various processing steps were extremely loud.
MSS collaborated with the client’s product development team to redesign the system’s platform and software interface
- Improved hardware design to reduce bulk and noise
- Provided input for design of a user-friendly software interface

Outcome: As a result of the redesign, our client was able to obtain additional valuable patents to protect its platform technology, and launched a product that would be appealing to clinical laboratory personnel.

2. Validation of a Point of Care Blood Analysis System

Our client’s handheld analysis system was the first to employ a single-use, barcoded microfluidics and biosensor array for the analysis of blood gas, electrolyte and metabolites at the point of care. Mount Sinai Services designed and executed validation studies required to support regulatory approvals from FDA and Health Canada.

Analytical Validation

MSS designed and executed a multi-site analytical validation study to compare the technology against gold-standard, laboratory-based analysis.
- Obtained required REB approval
- Managed the validation process at three independent testing sites, executing a testing protocol developed by the client
- Worked with the Mount Sinai Hospital Nursing Department to conduct end-user testing in the point of care environment
- Developed and submitted complete regulatory packages for FDA and Health Canada

Outcome: Our client successfully obtained marketing approvals for the device, and was able to launch a very successful commercial product.

3. Validation and Launch of a Companion Diagnostic Assay

Anti-EGFR therapies are a valuable tool in the treatment of colorectal cancer. However, approximately 40% of colorectal tumours have a mutation in the KRAS gene, which makes anti-EGFR therapies ineffective. It is important to identify patients with the KRAS mutation so that alternate treatments can be prescribed.

MSS worked closely with a global pharmaceutical sponsor to establish the KRAS mutation detection assay as companion diagnostic test for patients who might benefit from anti-EGFR therapies. In addition to validating the assay, MSS developed a sophisticated online test requisition system, expanding traditional tools to accommodate companion diagnostics and personalized medicine orders with complex reimbursement patterns from health centres across Canada.

Analytical Validation

MSS worked with scientists from a global pharmaceutical firm to refine and validate the KRAS assay in our GLP laboratory facilities.
- Used reference cell lines to challenge and confirm sensitivity claims of the leading commercial RT-PCR kit for KRAS mutation detection
- Worked with manufacture to transfer kit to an automatic diagnostic testing platform
- Validated kit performance characteristics against sequencing platform

Outcome: MSS demonstrated that the RT-PCR platform would support a robust, sensitive assay for KRAS mutation detection, and provided key data leading to Health Canada approval of the sponsor's therapeutic as a third-line treatment for CRC using the KRAS assay as a companion diagnostic.

Business Process Design

MSS developed business processes and a technology infrastructure to develop a pioneering system for the effective management of companion diagnostics orders, reporting and reimbursement.
- Working closely with clinicians as well as the sponsor’s operational team, MSS developed a web-based test requisition system to manage complex logistics, payment and reporting requirements.
- Customized system effectively tracks test requisitions, tissue sample shipping and handling, data collection and reporting as well as reimbursement.

Outcome: Mount Sinai Services serves as a central laboratory for KRAS referral testing from health centres across Canada.