CNA Rapid Sepsis Dx
CNAD has conducted multiple studies on sepsis patient populations and the CNA Rapid Sepsis Dx assay can be used to diagnose the onset of the disease before symptoms appear:
Figure 1: Accuracy determination of CNA Rapid Sepsis DX
These results compare extremely well against the current gold standard molecular test for sepsis – BRAHMS – which is using the biomarker Procalcitonin showing a mean sensitivity of approximately 75% and specificity of 79%, which can be applied at the point of ordering a blood culture (i.e. significant sepsis symptoms are already present).
While all existing sepsis diagnosis methods work only once the first clinical symptoms have appeared, the data collected for the CNA Rapid Sepsis DX assay thus far indicate that the test can be used with an accuracy of over 90% two to three days before the first clinical signs, thus increasing sepsis survival rates considerably and improving the quality of life for sepsis survivors due to the possibility to treat them earlier.
CNA Rapid Sepsis Dx uses standard and cost-effective Polymerase Chain Reaction (PCR) diagnostic equipment and PCR Standard Operating Procedures, which are already well established in blood laboratories worldwide, thus easing customer adoption.
We are concluding work to finalize the commercial test including the addition of a bacterial vs. fungal sepsis diagnosis, and potentially a Gram-positive vs. Gram-negative bacteria diagnosis before symptoms present.
The CNA Rapid Sepsis Dx results are better than anything available in the market today both in terms of test accuracy and how early a diagnostic result can be obtained, while at the same time being easily adoptable in blood labs around the world. We believe this test will have a profound positive impact on worldwide healthcare systems and patient outcomes.
Sepsis impacts the lives of >30M people annually and kills >6M patients globally per year. It is one of the most-costly challenges to the global healthcare systems. For many years, it was believed that pathogen invasion was responsible for the damage seen in sepsis. Today, sepsis is being redefined as a dysregulated host response to infection by bacteria, fungi or viruses, respectively.
The early diagnosis of sepsis, when coupled with early treatment, will reduce a hospital’s overall cost of treatment, will lead to improved compliance with insurance coding for reimbursement claims, and contribute to a reduction of sepsis impact to a hospital’s environment. But most importantly, it will make a world of a difference to patients, who can be treated earlier, thus increasing their chances of survival by more than 50-fold and reducing the risk of major lifelong impact from sepsis infections for sepsis survivors.
© 2019 CNA Diagnostics Inc.