Bluejay Completes Planned Clinical Studies for Symphony IL-6 Test
Bluejay Diagnostics (NASDAQ: BJDX) has completed its clinical studies for the Symphony IL-6 Test, a key milestone towards submitting a de Novo Marketing Application to the FDA by year-end. The studies included a reference range study and validation studies, the results of which will be revealed at the AACC Annual Scientific Meeting from July 26-28, 2022. The Symphony System aims to provide rapid, near-patient testing with results in approximately 20 minutes, enhancing decision-making in critical care settings.
- Completion of clinical studies for Symphony IL-6 Test, paving the way for FDA marketing application.
- Results to be presented at the AACC Annual Scientific Meeting, increasing visibility.
- Potential to establish Symphony IL-6 Test as a new standard for measuring IL-6 using whole blood.
- The Symphony IL-6 Test is still a development-stage product candidate and limited to investigational use.
- Forward-looking statements include risks regarding the FDA's classification of the product and the company's ability to meet its targets.
ACTON, Mass., July 06, 2022 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay”, “the Company”), a medical diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression, today announced completion of its previously planned clinical studies for the Symphony IL-6 Test (the “Test”). Results of these studies will be published at the 2022 AACC Annual Scientific Meeting being held July 26th to 28th in Chicago.
Neil Dey, Chief Executive Officer, said, “Completion of these studies, which consist of our previously disclosed reference range study, cut-off value study and cut-off validation study, marks an important milestone towards a potential filing of our de Novo Marketing Application with FDA by the end of the year. Our recently announced plan to pursue a de Novo regulatory pathway could establish the Symphony IL-6 test as the new standard for measuring IL-6 using whole blood and serve to validate the innovative nature our technology.”
Neil Dey continued, “Efficient measurement of clinically relevant biomarkers in critical care settings may help medical professionals make more timely and effective treatment decisions. With the progress made in our clinical program for the Symphony IL-6 Test, we are closer to executing our mission of providing first-in-class, near-patient, laboratory quality tests using whole blood.”
About the SymphonyTM System:
Bluejay’s Symphony System (the “System”) is designed to address the need for simple, reliable and rapid near-patient testing by providing quantitative measurements of specific biomarkers to determine the need for additional patient care and monitoring. The user-friendly System does not require any sample prep or dedicated staff and was shown in published clinical studies to deliver results in approximately 20 minutes.
The Symphony IL-6 Test is a development stage product candidate for investigational use only. It is limited by United States law to investigational use.
About Bluejay Diagnostics:
Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient product for triage and monitoring of disease progression. Bluejay’s first product candidate, the Symphony IL-6 Test for sepsis triage, is designed to provide accurate, reliable results in approximately 20 minutes from ‘sample-to-result’ to help medical professionals make earlier and better triage/treatment decisions. More information is available at www.bluejaydx.com.
Forward-Looking Statements:
This press release contains statements that the Company believes are “forward-looking statements” within the meaning of the Private Litigation Reform Act. Forward-looking statements may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest”, “will,” and similar expressions. Forward-looking statements in this press release include, without limitation, the Company’s ability to complete these clinical studies and to submit its marketing application with FDA by the end of 2022 and whether FDA determines to classify the Company’s product candidate as a De Novo application. The Company has based these forward-looking statements on its current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”), as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. You should not place undue reliance on these statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may be materially different from any future results or performance suggested by the forward-looking statements in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. The Company expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any changes in the Company’s expectations of results or any change in events.
Investor Contact:
Alexandra Schuman
LifeSci Advisors
alex@lifesciadvisors.com
t: 646-876-3647
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