Digital Biosciences Reports SepsisDx Results to the Defense Health Agency
A sepsis test that needs a urine sample rather than a needle, and a classifier that tells the clinician which biomarker drove its answer.
MDC Studio portfolio company Digital Biosciences has delivered its SepsisDx program summary to the Defense Health Agency under DoD award HT9425-23-C-0073. SepsisDx is a clinical decision support tool that estimates the likelihood of sepsis from a single urine sample, using two biomarker ratios measured by point-of-care ELISA: C-reactive protein normalized to creatinine, and interferon gamma-induced protein 10 normalized to creatinine. Normalizing to creatinine makes the reading independent of how hydrated the patient is, which has historically limited urinary biomarkers.
Sepsis affects more than 1.7 million adults a year in the United States and causes roughly 270,000 deaths. Every hour of delay in administering antibiotics raises mortality by 4% to 8%. The tests clinicians rely on work against that clock: blood cultures take 24 to 72 hours to return, and blood biomarkers require venipuncture and laboratory workflow, which in practice confines them to settings that have both.
Reported results
The classifiers were trained on an ICU cohort of 2,896 patients from a Turkish tertiary hospital and evaluated with five-fold cross-validation, returning AUROC between 0.941 and 0.960 across the logistic regression, neural network, and random forest models. At the operating threshold reported, the random forest reached 93.9% sensitivity, 90.1% specificity, and a negative predictive value of 97.9% — the figure that matters most for a triage tool, since it describes how often a "not septic" answer can be trusted.
Applied without retraining to 151 patients from a published urinary biomarker study, the model returned 88.7% accuracy and 98.0% specificity, and correctly classified 95.8% of patients with systemic inflammatory response syndrome as non-septic — the discrimination that separates a useful sepsis test from one that flags every inflamed patient. On a 100-patient extract of the MIMIC-IV critical care database it returned 83.0% accuracy. For comparison, the review literature places blood-based procalcitonin at an AUROC of 0.84, blood CRP at 0.76, and IL-6 at 0.71.
Each prediction is accompanied by a SHAP attribution showing which biomarker drove it, presented through a browser-based clinician interface with four-tier risk stratification. The company's view is that a decision support tool which cannot explain itself will not be trusted at the bedside.
Limited validation
Validation against native urinary assay data so far rests on a small number of samples from the Cooper University Hospital Emergency Department, and additional samples are being collected. Prospective validation with paired urine and blood samples is the next step, alongside multi-site testing across Department of Defense military treatment facilities, an FDA 510(k) pathway assessment, HL7 FHIR integration for laboratory systems, and an expanded biomarker panel.
A non-invasive test matters most where the alternative is unavailable rather than merely slower: forward military care, austere settings, pediatric patients, and high-throughput emergency department triage.
The program summary was prepared by Gil Blankenship, Nardine Ghobrial, Alexis Fuentes, and Bailey Fokin of the MDC Studio.
About Digital Biosciences
Digital Biosciences develops SepsisDx, a point-of-care clinical decision support system for early sepsis detection from urinary biomarkers. The company is led by Dr. Nardine Ghobrial and holds laboratory space at the Montgomery County Innovation Center. It is part of the MDC Studio portfolio. dbmsciences.com
About the MDC Studio
The MDC Studio is a MedTech startup studio in Baltimore, Maryland. It works with clinicians and engineers to turn ideas into working prototypes and into companies, providing engineering, business development, regulatory support, and shared laboratory and office space. The Studio is located in an Opportunity Zone at 300 West Pratt Street. Contact us for more information.