The speed at which innovative and improved diagnostics are developed can be hampered by the difficulty in obtaining or retaining clinical specimens. This may be due to a variety of reasons, such as rare markers, 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 takes precedence over the ability to collect specimens under defined conditions. The use of surrogate or simulated samples can foster innovation when clinical specimens are difficult to obtain or retain.

The goal of this MDIC Clinical Dx initiative is to establish a foundation under which the use of surrogate samples can support product development with an initial focus on studies to support product submissions.

The Surrogate Samples Work Group will present its framework describing how surrogate samples may be used to simulate clinical specimens to conduct validation studies during the development of in vitro diagnostic tests. The scope of the document covers in vitro diagnostic validation studies. The Framework defines surrogate sample, promotes the use and adoption of common terminology and describes a hierarchy to aid in surrogate sample selection.