Demonstrated 98% NPV1 to Identify COVID-19 Patients at Risk for Severe Illness
Study Data Indicate Symphony IL-6 Test Could be a Rapid and Precise Diagnostic Platform for Near-Patient Management of Critical Care
ACTON, Mass., July 27, 2022 (GLOBE NEWSWIRE) — Bluejay Diagnostics, Inc. (NASDAQ:BJDX) (“Bluejay” or the “Company”), a medical diagnostics company focused on developing cost-effective, rapid, near-patient tests for triage and monitoring of disease progression, today announced that positive results of analytical and clinical studies of Bluejay’s Symphony IL-6 Test were presented at AACC 2022, the leading industry conference for clinical laboratory medicine.
The presentation, Evaluation of a new, Near-Patient Testing (NPT) IL-6 Assay on Symphony Immunoanalyzer (K. Jaleta, et al, AACC Poster B-204), presented by investigators from the University of Texas Southwestern (UTSW) Medical Center in Dallas Texas, found the analytical and clinical performance of the Symphony IL-6 Test (“the Symphony IL-6 NPT”) is comparable to the Emergency Use Authorization (EUA)-approved Roche Elecsys® IL-6 assay2 (“the Roche Test”). It is mentioned in the presentation that “Dysregulated interleukin-6 (IL-6) levels underlie several pathological conditions, such as sepsis, progression of cancer, rheumatoid arthritis, and many other conditions. Prior studies indicate that high levels of IL-6 serve as an early indication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-induced hyperinflammation, disease severity, and multiorgan failure.”
Results from the analytical and clinical studies conclude that the Symphony IL-6 Test is an innovative technology for use in Emergency Department and Intensive Care Unit settings to identify COVID-19 patients at higher risk for severe disease, including the requirement for Invasive Mechanical Ventilation (IMV). This conclusion is based on the study results and the unique characteristics of the Symphony IL-6 NPT, relative to much larger, more expensive lab analyzers. Key differentiators noted by the authors include faster turn-around time (< 20 minutes), ease of use (tested directly from whole blood, without need for significant laboratory infrastructure) and analytical precision, as noted below.
Key Study Highlights:
- Clinical Performance (NPV)3: The Symphony IL-6 NPT demonstrated a 98% Negative Predictive Value (NPV), notably better than devices currently granted EUA by the Food and Drug Administration (FDA) for “clinical use” whose NPVs were recorded as 78.6%, 86%, and 92.9%. The 98% NPV indicates the usefulness of the test in ruling out the risk of severe disease, including the risk of IMV, in patients with COVID-19.
- Clinical Performance (Sensitivity and Specificity)4: An evaluation of 147 COVID-19 patient samples, including 18 IMV patients, found the Clinical Sensitivity and Specificity of the Symphony IL-6 Test were slightly better but comparable, based on Sensitivity and Specificity for the Symphony IL-6 NPT of 89% and 64%, respectively, to other devices currently permitted to be used clinically (granted EUA by the FDA).
- Analytical Performance: Results of an evaluation of 152 COVID-19 patient samples tested with the Symphony IL-6 NPT (using whole blood) and the Roche Test (using plasma) showed an excellent correlation between two test methods (r=0.9490)5,6. The authors also report that the analytical precision of the Symphony IL-6 NPT was acceptable, with less than 15% imprecision.
Neil Dey, Chief Executive Officer, said, “Bluejay is very pleased that the results of the Symphony IL-6 testing program are being presented at AACC 2022 by our collaborators from the UTSW Medical Center. The result of the independent study establishes the credibility of the Symphony IL-6 NPT in the critical care community.”
Mr. Dey concluded, “Bluejay is excited to be developing a potential solution to meet the market need for a rapid, reliable, cost-effective, near-patient tool to measure IL-6 levels using whole blood. We believe the Symphony technology will provide medical professionals the ability to make more timely decisions in determining the most effective treatment regimen in critical care.”
Bluejay plans to host a Key Opinion Leader (KOL) event during Summer 2022 to provide a detailed review of the Symphony IL-6 Test data presented at AACC and to discuss the importance of rapidly measuring IL-6 levels in near-patient, critical care settings.
