NEW YORK (GenomeWeb) – The National Institutes of Health announced today that it is seeking grant applications for projects evaluating the clinical potential of cancer biomarker assays that are already validated for research use.
Clinical cancer studies are increasingly reliant on robust markers of pharmacodynamics, mechanism of action, drug response, and other aspects of disease prevention and treatment, the NIH said in its funding announcement. However, "investigators are generally comfortable developing assays for research purposes, [and] may not have the expertise for developing assays for clinical purposes and navigating the regulatory requirements that clinical laboratory assays must meet. This can cause considerable delay and added expense to successfully conducting clinical trials," the agency added.
To address this issue, the NIH said that it intends to fund projects that enable the clinical use of biomarker assays already analytically validated in human cancer specimens. The agency noted that this funding opportunity is not intended to support the early-stage development of technologies or the conduct of clinical trials. Projects should be limited to the validation of assays to the point where they could be integrated into clinical trials, and focus on assays whose marker or classifier is likely to be used in treatment, prevention, or cancer control studies.