CNA Diagnostics
New Sepsis Diagnostic Could Save Over 1 Million Lives Each Year

The clock starts ticking once a patient has been diagnosed with sepsis. The medical condition, claiming six million lives and affecting 30 million people annually, increases victims’ mortality rate by 7.6 percent each hour following the appearance of the first symptoms. “The body starts responding as soon as sepsis sets in, but symptoms appear much later when the time window to diagnose the disease and treat it effectively has reduced considerably,” explains Dr. Christoph W. Sensen, Chief Scientific Officer and Director of CNA Diagnostics (CNAD). Sepsis, caused by the body’s inappropriate response to infection, is currently diagnosed following gold standards through a blood culture, which takes at least 24 hours to produce a result in a situation where every hour is critical. The newer BRAHMS molecular diagnostic test provides results that are 75 percent accurate, but it only works after the appearance of symptoms.

Gordon and Dr. Sensen lead their team at CNAD to develop molecular testing methods that can diagnose the onset of disease before symptoms appear. The company’s new product—CNA Rapid Sepsis Dx—accurately diagnoses sepsis up to three full days before symptoms present which, when coupled with early treatment, aims to reduce the societal impact of the disease and the overall financial burden sepsis causes to the worldwide healthcare system.

“The short time window between diagnosis and treatment for sepsis poses a big challenge,” informs David Gordon, CEO and Director of CNA Diagnostics. “We have developed the CNA Rapid Sepsis Dx assay to diagnose sepsis extremely early and expand the time attending physicians have to explore treatment options”. CNAD has now carried out multiple clinical trials on its CNA Rapid Sepsis Dx assay and is preparing for FDA product clearance and European CE marking. Besides providing a three-day margin to diagnose the disease, the results of the CNA Rapid Sepsis Dx assay are 90 percent accurate.

CNAD’s technology platform focuses on comparative changes in circulating nucleic acid (CNA) sequences in a patient’s disease state and uses bioinformatics to identify unique biomarkers. CNAD develops diagnostic kits, which include decision-making algorithms that convert complex body signaling systems into easy to interpret diagnostic results for improved patient treatment outcomes.

In a diagnostic test developed by CNAD, a small patient serum sample is collected and used directly on a Polymerase Chain Reaction (PCR) machine. “Using PCR allows for a quick and cost-effective solution to customer needs,” says Gordon, “PCR machines are frequently used in most diagnostic labs and can produce an accurate, low cost, result in less than 4 hours.” Importantly, CNA Rapid Sepsis Dx can be used direct from patient serum. This means no DNA extraction or preparation steps are required and training is straightforward. The lab technician simply pipettes the serum into the PCR, closes the lid, and waits for the result.

“Using this test, we can monitor patients at high risk of developing sepsis—people with weakened immune systems, or even the ones who met with gardening accidents,” informs Dr. Sensen. Due to the low cost of the test and ease of implementation into existing hospital protocols, CNA Rapid Sepsis Dx can be quickly integrated and used to monitor and support treatment of septic patients, as well as allow for earlier discharge of patients being monitored for sepsis that don’t have it.

During his early experiments, Dr. Sensen proved that host DNA biomarkers in mammals could be used in combination with decision-making algorithms to diagnose multiple diseases more accurately and earlier than other direct methods such as using the identification of specific pathogens in the blood.

The company continues to build on its scientific foundation. “As CNA Rapid Sepsis Dx is nearing commercialization, we are now evaluating new diseases diagnostics, as well as add-on sepsis tests, that are applicable to our technology platform,” says Gordon. “We are pleased to have the opportunity to bring improved diagnostic solutions to market and make a meaningful impact on mankind”.