Rapid Diagnostic Test Matches Gold Standard for Sepsis Detection

In the USA and Europe alone, sepsis accounts for USD 100 billion in annual hospitalization expenses. 80% of sepsis deaths could be prevented by early diagnosis and targeted antimicrobial treatment. 30%-45% of sepsis patients receive inappropriate initial antimicrobial therapy because current diagnostic techniques (blood cultures) deliver results in 1 to 10 days. Every hour of delay without appropriate therapy increases mortality by 7.6%. Now, a rapid diagnostic test for sepsis can identify the microbe(s) causing the infection in less than 3 hours, improving patient triage, supporting treatment decisions, enhancing antibiotic management (including de-escalation), and helping to prevent antibiotic resistance.

OCEAN Dx’s (Pessac, France) sepsis test is designed to rapidly identify the infection-causing pathogens within hours, helping physicians select the most effective antimicrobial strategy without delay. The test is designed to detect and identify 99% of sepsis pathogens (600 Gram-positive and negative bacteria) in less than 3 hours and has a revolutionary limit of detection of 2 cells/mL from as much as 9 mL of whole blood.

A clinical evaluation study of the OCEAN Dx sepsis test that involved 107 patients achieved results consistent with the gold standard for sepsis detection. The study delivered outstanding results from 237 blood samples. The test, which features an impressive detection spectrum covering over 1,000 bacterial species, provided results within a 5-hour turnaround time. It achieved 100% detection sensitivity and 100% negative predictive value (NPV) compared with the reference blood culture test and demonstrated a strong concordance in bacterial identification with mass spectrometry, 95% at the phylogenetic family level and 85% at the species level.

Presented at Sepsis Update 2025, the results showed 95% true positives versus blood culture, with detection of fastidious bacteria and resilience to antimicrobial inhibition. OCEAN Dx is completing the industrialization of its sepsis test and plans clinical trials in 2026, targeting CE marking. OCEAN Dx will launch its rapid sepsis diagnostic test in Europe by 2029.

“In our study, the test detected nearly three times more bloodstream infections than conventional blood cultures, with perfect sensitivity and negative predictive value, and results available very quickly,” said Dr. Antoine Dewitte, principal investigator of the study.

“We are pleased to announce that our sepsis rapid diagnostic test evaluation study has been a success, with an excellent average time-to-result of just 5 hours, that we expect to decrease to 3.5 hours”, added Franck Tarendeau, CEO of OCEAN Dx. “This is a great improvement since the detection and identification of sepsis-causing pathogens using blood cultures typically takes between 2 and 6 days.”

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