Best practices in the development of omics-based tests to guide patient care
*Lisa McShane, National Cancer Institute 


Successful translation of omics-based assays into clinically useful tests requires effective collaboration among scientists representing multiple areas of expertise relevant to ‘omics’-based test development. The US National Cancer Institute has developed a checklist of criteria that can be used to determine the readiness of an omics-based test for guiding patient care in clinical trials. The checklist criteria cover issues relating to specimens, assays, mathematical modeling, clinical trial design, and ethical, legal and regulatory aspects. The checklist is intended as an aid to investigators developing omics tests to guide them toward best practices, make them aware of common pitfalls in development, and enhance the reliability, reproducibility, and usefulness of omics research. The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy.