OCEAN Dx, a pioneer in rapid diagnostic solutions, today announced the successful completion of a clinical evaluation study for its innovative rapid diagnostic test for sepsis (formerly known as septicemia). Conducted by Dr. Antoine Dewitte’s team in the Intensive Care Unit (ICU) of Haut-Lévêque Hospital (Bordeaux University), the study involving 110 patients achieved results consistent with the gold standard for sepsis detection. This major 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 revolutionize sepsis care worldwide.
OCEAN Dx is supported by the Nouvelle-Aquitaine Region authority and Bpifrance.
A COMPANY SERVING PUBLIC HEALTH
OCEAN Dx was founded by Franck Tarendeau and Cyril Dian, two medical research scientists with extensive experience in the vaccine and in vitro diagnostics. The company develops innovative diagnostic solutions targeting infectious diseases, with a particular focus on sepsis. Other diseases include pneumonia, meningitis and Lyme disease.
Sepsis kills 11 million people worldwide every year and generates massive healthcare costs. In the USA and Europe alone, sepsis accounts for $100 billion in annual hospitalization expenses*. The cost of treating sepsis syndromes or victims experiencing septic shock in an intensive care unit (ICU) can exceed €30,000 per patient.
The global market for a rapid sepsis diagnosis test is estimated at €8.4 billion.
OCEAN Dx builds on its unique patented technologies to deliver advanced diagnostic solutions for managing patients with infectious diseases, particularly in critical situations: fast turnaround, broad pathogen detection and exceptional sensitivity. 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 carried out with the Bordeaux University Hospital delivered outstanding results on 237 whole blood samples collected at the patient’s bedside. The test, which has an impressive detection spectrum covering 1,000 bacteria, provided results in 5-hour turnaround time. It achieved 100% detection sensitivity and 100% detection Negative Predictive Value compared to the reference blood culture test and showed a strong concordance of identification with mass spectrometry of 95%. These promising clinical evaluation results will be presented at the Sepsis Update Congress 2025 (October 02-04 Heidelberg) and will be published in a scientific journal.
” 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, 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 revolutionize the way we diagnose sepsis and open new perspectives to better understand this complex syndrome.”
“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 5 hours, that we expect to decrease to 3,5 hours in its commercial version. This is a great improvement since the detection and identification of sepsis-causing pathogens using blood cultures and complementary tests typically takes between 2 and 6 days.” commented Franck Tarendeau, CEO of OCEAN Dx.
“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” Mr. Tarendeau added.
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.
*https://www.congress.gov/bill/118th-congress/house-bill/8078/text
ABOUT OCEAN Dx
Created in 2019, OCEAN Dx is a Bordeaux-based start-up specialized in in vitro diagnostics of infectious diseases. Its head office is located at SEML Route des lasers – Bâtiment Pleione – 11, Avenue de Canteranne in Pessac, France. OCEAN Dx is a deep tech company in the field of health care. The company is the winner of the i-Lab 2020 Competition and the i-Nov 2020 Competition.
ABOUT THE MAGELLAN ANESTHESIA-INTENSIVE CARE UNIT (Haut-Lévêque Hospital-Bordeaux University Hospital)
The Magellan Anesthesia and Intensive Care Department, located at the Haut-Lévêque Hospital (www.chu-bordeaux.fr/CHU-de-Bordeaux/Hôpitaux-et-sites-du-CHU/Groupe-hospitalier-Sud/) is one of the five anesthesia-ICU departments of the Bordeaux University Hospital. When it comes to management of medical and surgical abdominal and thoracic pathologies this department is at the cutting edge, with its ICU and recovery units and state-of-the-art technical facilities, providing innovative endoscopic, radiological and surgical interventional techniques, including liver and lung transplant surgery. The Magellan anesthesia-intensive care team also provides a strong framework for clinical and translational research (CTR), in close collaboration with the University of Bordeaux, focusing especially on infections, inflammation, microbiology, and sepsis immunology.
