CNA Rapid Sepsis Dx Results Released. Superior to All Existing Commercial Sepsis Diagnostic Solutions

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New diagnostic demonstrates ability to accurately diagnose sepsis up to 3 days before symptoms appear

CNA Diagnostics Inc. (the “Company” or “CNAD”) is pleased to announce the results of its recent blind study as part of its development of a new human sepsis diagnostic screen test.

“The CNA Rapid Sepsis Dx blind 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,” said Dr. Christoph Sensen, CSO of CNAD. “We believe this test will have a profound positive impact on worldwide healthcare systems and patient outcomes.”

This blind study, completed with a European clinical trial partner, the Medical University of Graz, consisted of 101 samples from 46 patients from a geographic location unrelated to the initial test development. Results of the CNA Rapid Sepsis Dx tests are as follows:

Proof of Concept Study (unblinded):

  • Sensitivity: 93.2%
  • Specificity: 89.0%
  • Study size: 153 Patients
  • Days before symptoms: N/A
  • Diagnosis time: 4 hour turnaround.

Blind Study:

  • Sensitivity: 90.6%
  • Specificity: 82.6%
  • Study size: 46 Patients
  • Days before symptoms: Up to 3 days before
  • Diagnosis time: 4 hour turnaround.

Both studies used the same 24 DNA biomarkers and same proprietary neural network algorithms for diagnostic decision making. The biomarkers and proprietary algorithms allow for diagnosis of sepsis up to three days before symptoms appeared. The results achieved exceed any commercially available sepsis diagnostic test.

Included in the unblinded study are sepsis samples with fungal, Gram-negative bacterial and Gram-positive bacterial pathogens, as well as control samples with non-sepsis disease conditions such as influenza, lymphoma and preeclampsia.

The blind study involved patients at high risk of developing sepsis, and includes bacterial sepsis samples with Gram-negative and Gram-positive pathogens, unidentified positive culture and diagnosis without positive culture. The samples had been collected over time, including before and after a surgical procedure, with the control samples from the patients discharged without sepsis after a surgery and the sepsis samples of those patients eventually diagnosed with sepsis after a surgery.

The results of these two studies form the overall proof of concept that indicates the CNA Rapid Sepsis Dx test can accurately diagnose sepsis days before symptoms appear with the use of standard and cost effective PCR based diagnostic equipment. A diagnostic decision can be made within 4 hours from blood draw to patient results.

CNAD is presently optimizing the test which management believes will lead to improved performance over the blind results that are being published in reputable scientific journals. CNAD’s commercial variant of the test is expected to use fewer biomarkers. CNAD is also developing its sepsis test to accurately differentiate between bacteremia and fungaemia in the days before symptoms develop, and is planning to conduct a fully independent, multiplexed based, validation study with a European clinical trial partner in early 2019.

The Company has contracted with Wayne State University to conduct a U.S. based clinical trial in 2019 similar to the European trials described above. The U.S. based study will support FDA clearance and commercialization of CNA Rapid Sepsis Dx in the United States.

Sepsis impacts the lives of >30M people annually and kills >6M globally. It is one of the largest costs to the U.S. and global healthcare systems. The early diagnosis of sepsis when coupled with early treatment reduces a hospital’s overall cost of treatment, leads to improved patient outcomes, improves compliance with insurance coding for reimbursement claims, and contributes to a reduction of sepsis impact to a hospital’s environment.

About CNA Diagnostics:
CNA Diagnostics Inc. 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 (mammalians). Test development is focused on disease stages prior to the onset of observable clinical symptoms, which currently cannot be detected reliably with existing commercially available methods. The Company commercializes its tests primarily by licensing its technology to strategic partners.

Forward-Looking Information Advisory
Certain information in this press release is forward-looking within the meaning of certain securities laws, and is subject to important risks, uncertainties and assumptions. This forward-looking information includes, among other things, information with respect to grant funding and related projects, scientific studies and results, assumptions about future economic conditions and courses of action, and the Company's beliefs, plans, expectations, anticipations, estimates and intentions. The words “may”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “anticipate”, “estimate”, “expect”, “intend”, “plan”, “target” and similar words and expressions are used to identify forward-looking information. The forward-looking information in this material change report describes the Company's expectations as of the date of this news release and accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While the Company may elect to, it does not undertake to update this information at any particular time.

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