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NIH to Provide Additional Funding for Clinical Validation of Cancer Diagnostics

NEW YORK (GenomeWeb) – The National Institutes of Health has announced that it will allocate further funding to support the refinement of molecular cancer diagnostics that have shown promise in their initial development but require additional refinement before they can be tested in National Cancer Institute-supported clinical trials.

The funding opportunity is limited to investigators with ongoing U10 grants, who may receive up to $150,000 in annual direct costs for up to two years direct costs in addition to the funding they currently receive. The money is earmarked specifically to help grantee's meet the requirements for the analytical and clinical validation of diagnostic assays and prepare them of use in clinical studies funded by the NCI.

"NCI-supported clinical trials increasingly depend upon molecular diagnostics to be measured as targets for therapy … or other essential or integral markers for treatment, prevention, or cancer control trials," the NIH said. "These markers may be pharmacodynamic, mechanism of action, as well as predictive or response markers. They may also be related to risk of cancer in prevention or cancer control trials."

However, the NIH said that investigators developing such tests "generally do not understand the rigor and regulations that clinical laboratory assays must meet. This causes considerable delay and added expense to the performance of clinical trials."

As such, the NIH is seeking revisions of currently active research grants that require additional funding to clinically validate existing assays using human specimens so that they may be developed into full-fledged molecular diagnostics for use in clinical trials, it said. NCI staff also will proactively help investigators meet the necessary requirements in order to mitigate these issues. 

Projects appropriate for this funding opportunity must involve assays whose markers or classifiers are likely to be used in the treatment, prevention, or cancer control trials; and should use technologies already in use or soon to be approved for use in clinical labs, according to the NIH.

The assay, the agency added, must be near the end of analytical validation, with additional fine-tuning of cutoffs or thresholds for a positive assay left for clinical validation.

Additional information about the funding opportunity can be found here.