The rapid diagnostic test achieved 100% sensitivity and negative predictive value in a 107-patient evaluation at Bordeaux University Hospital.
Ocean Dx announced the successful completion of a clinical evaluation study for its rapid diagnostic test for sepsis, with results matching the gold standard for sepsis detection in a 107-patient study conducted at Bordeaux University Hospital.
The study, led by Antoine Dewitte’s team in the intensive care unit, analyzed 237 whole blood samples collected at patients’ bedsides. The test achieved 100% detection sensitivity and 100% negative predictive value compared with reference blood culture tests, with results available within five hours.
The diagnostic test features a detection spectrum covering more than 1,000 bacterial species and demonstrated strong concordance in bacterial identification with mass spectrometry—95% at phylogenetic family level and 85% at species level. The test’s ability to detect fastidious bacteria and resist growth-inhibiting antimicrobials resulted in 95% confirmed true-positives while minimizing false-positives compared to blood culture.
“This clinical study clearly demonstrates the potential of Ocean Dx to change the management of patients with suspected sepsis in the ICU,” says Dewitte, PhD, principal investigator at Bordeaux University Hospital, in a release. “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.”
Commercial Timeline and Performance
The company expects to reduce turnaround time to 3.5 hours in the commercial version, compared to the current two- to six-day timeframe for blood cultures and complementary identification tests.
“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,” says Franck Tarendeau, chief executive officer of Ocean Dx, in a release.
Ocean Dx is completing the industrialization of its sepsis test and plans clinical trials in 2026, targeting CE marking. The company plans to launch its rapid sepsis diagnostic test in Europe by 2029.
The clinical evaluation results were presented at the Sepsis Update Congress 2025, with detailed findings planned for an upcoming scientific publication.
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