Rapid diagnostic firm OCEAN Dx has announced the successful completion of a clinical evaluation study for its innovative rapid diagnostic test for sepsis, which shows it achieved results consistent with the gold standard for sepsis detection.
Conducted by Dr Antoine Dewitte’s team in the Intensive Care Unit (ICU) of Bordeaux University Hospital, the study involved 107 patients. This breakthrough marks an important milestone in OCEAN Dx’s mission to provide clinicians with fast, accurate, and life-saving diagnostic tools. By improving patient triage, supporting treatment decisions, enhancing antibiotic management (including de-escalation), and helping to prevent antibiotic resistance, this test has the potential to revolutionise sepsis care worldwide.
The OCEAN Dx sepsis test is designed to rapidly identify the infection-causing pathogens within hours helping physicians select the most effective antimicrobial strategy without delay.
The clinical evaluation study conducted in collaboration with Bordeaux University Hospital delivered outstanding results from 237 whole blood samples collected at the patient's bedside. The test, which features a detection spectrum covering over 1,000 bacterial species, provided results within a five-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 phylogenetic family level and 85% at the species level. Moreover, the test’s ability to detect and identify fastidious bacteria and its resilience to growth-inhibiting antimicrobials resulted in 95% confirmed true-positives and minimised the number of false-positives compared to blood culture. These promising clinical evaluation results were recently presented at the Sepsis Update Congress 2025 and will be detailed in an upcoming scientific publication.
"This clinical study clearly demonstrates the potential of OCEAN Dx to transform the management of patients with suspected sepsis in the ICU,” said Dr Antoine Dewitte, the study’s principal investigator at Bordeaux University Hospital. “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. Such performance could enable physicians to adapt antimicrobial therapy much earlier, improving patient outcomes while reducing unnecessary broad-spectrum antibiotic use and the emergence of resistance. Beyond its immediate clinical value, this technology could revolutionise the way we diagnose sepsis and open new perspectives to better understand this complex syndrome.”
Franck Tarendeau, CEO of OCEAN Dx commented: “We are extremely pleased to announce that the goals of our sepsis rapid diagnostic test evaluation study have been achieved, demonstrating unprecedented clinical performance, with outstanding reliability and assay consistency and an excellent average time-to-result of just five hours, that we expect to decrease to 3.5 hours in its commercial version. With the success of the clinical evaluation study, we are confident that our rapid diagnostic product is ready for clinical trials and holds strong potential to become an alternative to blood cultures and related identification tests in the near future.”
OCEAN Dx was founded by Cyril Dian and Franck Tarendeau (pictured above), two medical research scientists with extensive experience in the vaccine and in vitro diagnostics industries. The company develops innovative diagnostic solutions targeting infectious diseases like sepsis, pneumonia, meningitis and Lyme disease. The company is completing the industrialisation of its sepsis test and plans clinical trials in 2026, targeting CE marking, with launch of a rapid sepsis diagnostic test in Europe planned by 2029.