Currently, the speed at which innovative and improved diagnostics are developed can be hampered by the difficulty in obtaining clinical specimens. This may be due to a variety of reasons, such as rare markers, lack of specimens with markers at the high or low end of the range, specimen stability, the difficulty in obtaining certain specimens due to clinical practice, or patient care taking precedence over the ability to collect specimens under defined conditions. The use of surrogate samples can foster innovation when clinical specimens are difficult to obtain.
The Surrogate Sample working group conducted an analysis of real-world examples of the use of surrogate samples to document established uses of surrogate samples to verify or validate the safety and effectiveness of an IVD medical device. The goal of the project was to establish a foundation under which the use of surrogate samples can support product innovation, with an initial focus on studies to support product submissions.