NASA Glenn Research Center is soliciting information about potential sources for a Point of Care (POC) Diagnostics system that can be developed in support of flight research on the International Space Station (ISS).
With the retirement of the Space Shuttle, biological sample return from the ISS will be challenging due to volume limitations. Rather than relying on sample return and ground-based analysis, in-flight analysis will provide point of care assessment of analytes of interest to the NASA biomedical research community.
The requirement for potential in-flight lab analysis technologies specifies four high priority analytes targeted to demonstrate the technology: Vitamin-D, N-Telopeptide, interferon gamma, and tumor necrosis factor alpha. Within the scope of any funded effort, the initial four analytes are to be measured and validated against current laboratory gold standards, such as ELISA.
NASA has additionally detailed an expanded set of high priority analytes to assess extensibility of the technology. Companies are requested to provide information on the feasibility, development time and future potential for expanding the platform to include these forty-three other bone, immune, hormone and oxidative stress biomarkers (listed in the solicitation).
Anticipated goals during the 12-month contract include (for all four assays) assay feasibility, assay validation against a recognized laboratory standard, a multiplexed demonstration of all four assays, and an on-site demonstration.
Minimum validation will include simultaneous testing of no less than n=6 human serum samples. Though it is not required, the proposer is encouraged to develop the analytes in whole human blood, whereby no less than n=6 test subjects provide whole blood samples in the laboratory. Where serum is used as a sample, the proposal shall delineate the necessary steps to preprocess whole human blood to an acceptable sample that is ready for testing, while being mindful that the in-flight operational concept is to minimize and simplify procedural steps from crewmember blood draw (finger prick) to analysis.
The technology sought should not be precluded from operating in zero-gravity and any proposal is required to provide rationale as to why the device would be able to be operable in a space environment.
Should a Request For Proposal (RFP) result from this information-gathering action, the estimated award date for the contract is fall of 2012. Full details are available under NASA Soliciation NNC12ZMS016L. The deadline for response is April 9, 2012.
