It is important to understand how the diagnostic test will lead to an improved clinical outcome. The resulting assay must also address a market need and have a unique position over other similar tests in the field.
Data that shows clinical significance of the analyte target is desirable. If data is emerging then a proposed mode of action and rationale regarding how the target fits with clinical utility is desirable. In addition, clarity around the target sensitivity required to perform clinically meaningful tests is needed.
Access to reagents and controls
Reagents, controls and test material required to develop the assay should ideally be readily available. To that end, sources of materials at scale are desirable. Ideally, these will include binding molecules, reporter systems, controls, clinical samples and sources of purified analyte.
Understanding the extent and experience of your in-house team will help us identify gaps (if any) as the project progresses through to a commercial end point. We also need to know if your team can transfer the technology through the development life cycle or are involved in subsequent business development or technical sales.
Freedom to operate
MRCT will carry out searches of the relevant intellectual property around the proposed diagnostic target. This will include reagents and assays and other markers against the clinical condition. It is important that MRCT and our collaborators have the necessary freedom-to-operate before commencing a diagnostic development project.
Potential to generate protectable intellectual property
It is important that there is existing IP protection or the potential to generate patentable IP around the relevant diagnostic assay or target analyte developed under the program.
MRCT has the capability to progress diagnostic assay development projects to the point of demonstrating clinical utility and early pre-clinical validation. We then seek to identify a partner to progress this further.