Wayne State University will lead the U.S. clinical trials for a new human sepsis diagnostic test that can provide results within four hours at a hospital or medical clinic.
CNA Diagnostics Inc. announced the signing of an agreement with Wayne State University to lead the trials in support of Food and Drug Administration approval for its Rapid Sepsis Dx. In proof-of-concept studies, CNA Rapid Sepsis Dx has proven capable of detecting bacterial and fungal human sepsis in advance of clinical symptoms, using blood serum and processed on industry standard reverse transcription polymerase chain reaction equipment for turn-around of results in approximately four hours.
It can take several days to identify the bacterial strain causes sepsis using standard blood culture techniques.
The company said that Wayne State University will provide access to tissue samples from a broad demographic of patients and a range of high-risk groups, as well as lead the U.S. clinical trials demonstrating the efficacy of CNA Rapid Sepsis Dx. That team will be led by Robert Sherwin, Robert Sherwin, M.D., F.A.C.E.P., F.A.A.E.M., clinical associate professor of Emergency Medicine and director of Clinical Research in Emergency Medicine at Sinai Grace Hospital. Dr. Sherwin also serves as chief science officer of Clinical Research One at WSU.
“The CNA Diagnostics’ method fills a vital need currently unmet by any other available diagnostic technology. 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,” Dr. Sherwin said. “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 Inc. is an Alberta, Canada-based 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,” said David Gordon, chief executive officer of the company. “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 the clinical trials and submission of results to the FDA by the end of 2019.