Table 2.

New technology platform translational potential checklist

What are the possible translational or clinical research applications?

Does the method meet an unmet medical need or significantly improve on existing technology? Any competition?

Provide technical description as needed (critical hardware and software components; time for data acquisition; data analysis parameters; platform requirements; etc). Are there redundant instrument/systems?

Are there any unusual sample requirements (blood or tissue, shipping, pre‐analytic processing, storage conditions, stability, etc)?

Describe the statistical analysis used; verification/validation of the routine.

What analytical verification/validation studies; clinical validation; correlation studies have been done? What method is used for comparison?

Are there other studies/publications using the method?

What is the intellectual property status? Are there other stakeholders in the technology?

What facilities are required to run the test? Will samples be run in an academic or CLIA‐certified laboratory; distributed or in a single location?

CLIA, Clinical Laboratory Improvement Amendment.