The purpose of the clinical study on 110 patients, conducted in collaboration with the Haut- Lévêque Hospital of the Bordeaux University Hospital (CHU), is to evaluate the clinical performance of the prototype for a rapid diagnostic test for sepsis developed by OCEAN Dx.
OCEAN Dx, a start-up specialized in in vitro diagnostics of infectious diseases, has announced the launch of a clinical study on an innovative prototype for its rapid diagnosis test for sepsis (formerly called septicemia). The study is conducted in conjunction with the team of Dr. Antoine Dewitte of the Bordeaux CHU. This sepsis test can identify, within a matter of hours, the infection-causing pathogen out of 600 possible sepsis-inducing bacteria. The new tool will help clinicians to quickly determine the right strategy in selecting antibiotics, optimize their use, and save lives. The design and development of this revolutionary test was supported by funding from the Nouvelle-Aquitaine Region authority and Bpifrance, a French public investment bank.
A COMPANY SERVING PUBLIC HEALTH
OCEAN Dx was founded by Franck Tarendeau and Cyril Dian, medical research scientists with experience in the vaccine and in vitro diagnostics industries. Their company develops innovative diagnostic solutions targeting infectious diseases, especially sepsis*. Other diseases include pneumonia, meningitis and Lyme disease.
Sepsis kills 11 million people worldwide every year, including 57,000 in France, and generates high health care costs (€1.5 billion in France and $24 billion in the United States). The cost of treating sepsis syndromes or victims experiencing septic shock in an intensive care unit (ICU) is €45,000 per patient.
The global market for a rapid sepsis diagnosis test is estimated at €8.4 billion.
OCEAN Dx builds on its disruptive technology, offering revolutionary diagnostic tests to manage patients with infectious diseases where diagnostic requirements are extreme: short response time, broad detection spectrum and high sensitivity. The purpose of the OCEAN Dx sepsis diagnostic test is to identify infection-causing pathogens within hours and steer doctors toward the right antibiotic strategy without delay.
“The aim of this study, conducted in collaboration with the ICU of Dr. Antoine Dewitte at the Bordeaux University Hospital, is to evaluate the clinical performance of our rapid diagnostic test for sepsis, representing a key first step in the clinical development of our test. It will demonstrate the robustness of our test for rapid identification of the infection-causing microbe in patients with suspected sepsis and to prove its effectiveness for clinicians treating an infectious disease that costs the lives of tens of thousands of people each year in France,” according to Franck Tarendeau, CEO and co-founder of OCEAN Dx. “Today, clinicians can only use a patient’s blood culture to diagnose sepsis. Yet these blood tests take from two to five days to yield a result, while the patient’s survival is at risk within a matter of hours. Providing a result within hours, our rapid diagnostic test for sepsis will help clinicians to select the right antibiotic treatment at an early stage of the disease, thereby increasing a patient’s chances of survival.”
“This clinical study on 220 samples from patients suspected of sepsis is very important because it will also give us an idea of the scale required for our upcoming regulatory clinical study to earn the CE marking. This future study should involve 1000 patients from several hospitals,” adds Cyril Dian, CTO and co-founder of OCEAN Dx. “Thanks to this new rapid diagnostic test, mortality from septic shock, up to almost 35% today, could eventually decrease. By allowing clinicians to choose the right antibiotic treatment in the first hours of symptom onset, our test will help to cure patients more quickly through better management of antibiotics and antibiotic resistance. This will limit bed occupancy times in hospitals and thereby reduce health care costs.”
OCEAN Dx will commercialize its rapid diagnostic test for sepsis both in France and internationally by 2028.
“The test looks particularly promising, with extremely encouraging preliminary results. It could truly help us to identify patients suffering from sepsis, better understand the disease, and treat it more effectively. This is a major technological innovation. The test developed by OCEAN Dx foreshadows the microbiological tests that will be available to clinicians in the future” says Dr. Antoine Dewitte.
* Sepsis, formerly called septicemia, is a condition in which the body’s response to a generalized infection from a pathogen present in the blood causes injury to organs or tissues, possibly leading to death.
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. Its scientific council is composed of several intensive care specialists, including members of CRICS-TRIGGERSEP, a French network of hospital clinical research centers dedicated to sepsis. 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.
