Specific Diagnostics said it plans to apply CE marking to the Reveal system next year, followed by submission to the FDA for 510(k) clearance.
The award will fund optimization of the Hemopurifier exosome isolator, with an eye towards developing applications in cancer research and clinical care.
The team said it will partner with startup Early Diagnostics to commercialize the assay, which integrates DNA methylation analysis and computational technology.
The National Institutes of Health Commercial Accelerator Program helps small healthcare and life science companies bring their products to market.
The funding will help the consortium continue creating and updating PGx guidelines, adding drug-gene pairings, and creating electronic tables that can be integrated within EHRs.
The firm recently announced a $3.15 million grant from the NIH, and it supported work that resulted in the first-ever digital primary diagnosis of a suspected cancer case.
The five-year award will go toward developing a tool that will be based on digitized hematoxylin and eosin (H&E)-stained pathology images alone.
The funding builds on more than $1.7 million already awarded to the firm, which is building a diagnostic for characterizing patients in clinical trials.
The company plans to develop a liquid biopsy assay that can identify patients most likely to benefit from treatment with checkpoint inhibitors.
The NSF and NIH awarded the firm separate grants to develop the system, which can provide results in five minutes from a drop of blood.