Wayne State University in Detroit has signed an agreement with Canada’s CNA Diagnostics Inc. to lead the U.S. clinical trials for a new human sepsis diagnostic test that can provide results within four hours at a hospital or clinic. Standard blood culture techniques take several days to identify the bacterial strain that causes sepsis.
According to the Centers for Disease Control and Prevention, sepsis is the body’s extreme response to an infection and is life-threatening. It happens when an infection already in the body triggers a chain reaction that can, without timely treatment, lead to tissue damage and organ failure.
The trials could lead to Food and Drug Administration (FDA) approval of Rapid Sepsis Dx. In proof-of-concept studies, the test has proven capable of detecting bacterial and fungal human sepsis in advance of clinical symptoms using blood serum.
WSU will provide access to tissue samples from a broad demographic of patients and a range of high-risk groups.
“The CNA Diagnostics’ method fills a vital need currently unmet by any other available diagnostic technology,” says Dr. Robert Sherwin, clinical associate professor of emergency medicine and director of clinical research in emergency medicine at Sinai Grace Hospital. He is also chief science officer of Clinical Research One at WSU. “It provides the opportunity to identify developing infections or sepsis in any emergency department or hospital patient days before there is clinical evidence or complications become irreversible.
“In the shift from a fee-for-service to a value-based reimbursement model, this fast and precise measurement of biomarker changes at the patient level will be mandated and a virtual game-changer. The CNA Diagnostics’ platform, through its unique approach of measuring the host’s specific response to a pathogen, epitomizes this concept of precision medicine and will represent an indisputable value for hospitals and health-care facilities.”
CNA Diagnostics is a molecular diagnostics company focused on the development of diagnostic tests for the early detection of the presence of disease in humans and animals. Test development is focused on disease stages prior to the onset of observable clinical symptoms that cannot be detected reliably with existing commercially available methods.
“We are pleased to begin working with Wayne State, its network of hospital partners, and Dr. Sherwin as we undertake FDA and European Medicines Agency regulatory approvals in support of commercialization,” says David Gordon, CEO of CNA Diagnostics. “The nexus of the research clinic, diagnostic lab services, and working hospital will be important for the stakeholders to really grasp how early detection of sepsis can help save lives.”
Based on pre-submission comments from the FDA, the clinical trials’ design and results will be used as validation studies in support of FDA approval as a medical device. Sample collection is expected to begin in early 2019, followed by completion of clinical trials and submission of results to the FDA by the end of 2019.
