The US National Cancer Institute last week re-issued two program announcements intended to encourage companies and academic institutions to develop new biomarkers for disease prognosis or for predicting a patient's response to therapy, but applicants have decreasing cash to compete for.
The two PAs are called Phased Innovation Research in Cancer Prognosis and Prediction R21/R33 and R33 — or PA-06-434 and PA-06-435. NCI is soliciting grant proposals under the NIH R21/R33 Phased Innovation grant mechanism and the R33 mechanism, which separates the first, proof-of-principle, stage from the second, development, stage. Submission deadlines are available here.
The PAs are updated versions of similar announcements that the agency has had available since about 1998, said Tracy Lively, the associate chief of the NCI diagnostics branch in an interview this week. "The NIH is moving toward the process of accepting grant applications electronically … various announcements have been re-issued with new numbers and different instructions."
To date, the NCI has been receiving about 50 applications per year under the program, with the number of accepted applicants approximately "tracking our shrinking pay line," said Lively. Where 10 might get funding per year at the project's inception, "now it's more like three or four," said Lively.
The NCI has been receiving about 50 applications per year under the program, with the number of accepted applicants approximately "tracking our shrinking pay line."
The NCI estimated that the combined project — the R21/R33 PA — should fund as many as 10 awards for no longer than five years. The awards are limited to $275,000 in direct costs over the first two years, and no more than $200,000 in a single year. The R33 portion of the PA has no direct cost limits, but applications requesting $500,000 or more in direct costs in a single year will require prior approval, the NCI said. The R33 route is intended for applicants who already have sufficient preliminary data to support development, application and evaluation of clinical utility.
Through the two PAs, the NCI hopes to spur biomarker and diagnostics developers to move beyond the cycle of discovering promising biomarkers that fail to reach the clinic, one after the other. In order to become new diagnostic tests, these biomarkers need large numbers of patient samples accompanied by clinical data, and a "robust, efficient assay technique," as well as "substantial statistical input," the agency's PA said.
An example of the kind of early-stage test that the NCI is hoping to encourage includes a diagnostic currently under development by undisclosed researchers that uses RT-PCR to detect tiny amounts of metastatic cancer cells in lymph nodes during lymphectomy surgery, said Lively.
Diagnostic discoveries emerging from the two-step R21/R33 process are ultimately envisioned by the agency to have enough of a statistical foundation to support larger clinical trials, or to pursue clearance through the US Food and Drug administration as new devices or analytic reagents, the NCI said.
The NCI requires applicants for the R21/R33 projects to demonstrate that they can reach their R33 goals, either by providing information or by proposing milestones on the way to the final project. Applicants should also submit a description of the R33 phase that reviewers can evaluate for significance and strength of experimental design. Descriptions should include evidence of clinical utility, as well as correlations between existing clinical measures and those of the new diagnostic test.
— Chris Womack ([email protected])