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.
By examining metagenomic data of bacterial species in a patient's gut, the researchers aim to improve diagnosis and long-term nutritional intervention and treatment.
The method, presented at the European Congress of Clinical Microbiology and Infectious Diseases, may provide results in hours rather than a week or more.
Industry executives said that clinical needs associated with antimicrobial resistance and sepsis are generating more interest in AST technologies.
Specific Diagnostics said that the CARB-X funding will enable it to prepare its AST instrument for clinical trials and regulatory validation.
The company has initial financing of $35 million, and has licensed its foundational SHERLOCK and INSPECTR technologies from the Broad and Harvard, respectively.
Since moving to rapid molecular testing, the lab has doubled its billable test volume, largely through increasing clients for its outreach lab services.
The Boston-based startup will use the funds to expedite prototype development of its sample preparation technology and computational approach.
The firm had also applied for marketing clearance for its gram negative and fungal pathogen panels in October.
The company is developing a new gold standard comparator test after it encountered problems with typical culture methods it used in developing a new pneumonia assay.