In development of IVDs, the transition to large subject-based studies is a major milestone in progress toward marketing approval. The test product has proven itself in reproducibility and validation studies, often involving banked samples. The developer can see years of effort at last culminating in revenue generation. Only one step remains – a large subject-based study to show that the diagnostic performs satisfactorily in the intended population and intended use.
For many companies, that last step is a doozy. A large subject-based study calls for a new set of capabilities. What’s more, each large subject-based study of an IVD meets the Merriam-Webster definition of “doozy” as “an extraordinary one of its kind” and “something that is unusually good, bad, big, severe.” Successfully conducting such a study requires a detailed understanding of the environment in which the test diagnostic will be used and close attention to the logistical issues in parallel testing with a gold-standard comparator and standard-of-care process.
For example, a study of an IVD for human papilloma virus and a study of an IVD for colorectal cancer will impose operational requirements that differ in far more ways than site selection. As an FDA guidance states, an HPV diagnostic study must address the possibility that a target neoplasia may spontaneously resolve. This can lead to differing results between the test diagnostic and the comparator because of changes in samples rather than differences in diagnostic accuracy. A blood-based diagnostic may have sample issues of its own, such as low tolerance for hemolysis. If so, sample collection and processing must observe and record sample quality at stages from collection to testing and final storage.
Health Decisions is providing IVD sponsors with a white paper to help ensure that their large subject-based IVD studies are doozies in a good way. Six Essential Steps for Successful Execution of Large Subject-Based IVD Studies will enable IVD companies to plan a PMA or 510(k) study that reduces risks, minimizes timelines and paves the way for early marketing approval. We hope you find the white paper useful and look forward to your feedback.