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NIH SBIR Phase ILife sciences: diagnostics
Point-of-care diagnostics company
$314K To fund analytical validation of a point-of-care assay
The challenge
An early-stage diagnostics company had promising bench data but no funded route to the analytical validation study payers and regulators would expect. The team had never written to an NIH study section and did not know which institute owned their indication.
What we did
- Matched the indication to the right NIH institute and omnibus topic, then structured the specific aims around unmet clinical need.
- Built the research strategy, preliminary data narrative and human subjects sections with the PI, who met the primary employment requirement.
- Prepared biosketches, letters of support and the eRA Commons submission package.
The result
A Phase I award of $314K covering the validation study, generating the evidence needed for a Phase II fast-track submission.
Client name withheld at their request; references available on request.
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