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NCI to Fund Research on Effects of Biospecimen Variability on Assay Development

NEW YORK (GenomeWeb) – The National Cancer Institute is seeking grant applications for research projects that will investigate and mitigate the challenges that pre-analytical biospecimen variability presents to clinical assay development.

As the starting material for biomarker assays, biospecimens are essential to personalized medicine. However, an increasing number of reports suggest that pre-analytical factors such as post-resection handling of clinical biospecimens can significantly impact assay results.

"In fact, pre-analytical processing has been highlighted as a significant impediment in the development of predictive biomarkers for oncology," the NCI stated in its funding opportunity announcement. "Pre-analytical variability has also been identified as a challenge in the implementation of next-generation technologies in the analysis of tissue biopsies."

To tackle this problem, the NCI announced that it aims to fund research that will identify and address pre-analytical factors around biopsy biospecimens that negatively affect clinical assay results and reproducibility.

Funded projects are expected to align with current NCI efforts to optimize clinical biomarker assays utilized in agency-sponsored treatment trial networks and to produce data needed for evidence-based biospecimen practices to support clinical trials.

Projects are also expected to involve "emerging and clinically relevant biomarker assays for a variety of molecular platforms," the NCI noted, and to test assay performance and limits of detection of biomarkers under different pre-analytical conditions.

Funded projects will involve multidisciplinary scientific teams that must include investigators currently involved in NCI-sponsored Phase I and Phase II clinical trials.

The NCI has not specified the amount of funding that it will make available for these projects, but said that application budgets are limited to $250,000 a year in direct costs.

Additional information about the funding opportunity can be found here.