Announcement • Jun 03
Bluejay Diagnostics, Inc. announced that it expects to receive $8.500007 million in funding Bluejay Diagnostics, Inc. has entered into securities definitive agreements to issue 3,655,917 common stock at a price $2.325 per share for gross proceeds $8,500,007.025 and series G warrants to purchase up to 3,655,917 shares of common stock and short-term series H warrants to purchase up to 3,655,917 shares of common stock at a purchase price of $2.325 per share of common stock on June 2, 2026. The series G warrants and the short-term series H warrants will have an exercise price of $2.075 per share and will be immediately exercisable upon issuance. The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the securities issued in the private placement and shares of common stock underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The transaction is prior to deducting placement agent’s fees and other offering expenses payable by the Company. The transaction is expected to close on June 3, 2026. New Risk • May 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$6.7m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$6.7m free cash flow). Earnings have declined by 25% per year over the past 5 years. Shareholders have been substantially diluted in the past year (177% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.78m market cap). Announcement • May 04
Bluejay Diagnostics, Inc., Annual General Meeting, Jun 09, 2026 Bluejay Diagnostics, Inc., Annual General Meeting, Jun 09, 2026. Location: 360 massachusetts avenue, suite 203, acton, ma 01720, United States Announcement • Mar 18
Bluejay Diagnostics, Inc. announced that it has received $0.125 million in funding On March 17, 2026, Bluejay Diagnostics, Inc. closed the transaction. New Risk • Mar 08
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$6.2m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$6.2m free cash flow). Earnings have declined by 33% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 6x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.81m market cap). Minor Risk Share price has been volatile over the past 3 months (14% average weekly change). Announcement • Feb 18
Bluejay Diagnostics, Inc. Successfully Enrolls 545 Patients in SYMON™? II Study and Advances Manufacturing Readiness into 2026 Bluejay Diagnostics, Inc. announced that it has successfully enrolled 545 patients in its SYMON™? II multicenter clinical study and has made substantial progress in advancing manufacturing readiness and technology transfer initiatives into 2026, representing a key execution milestone as the Company transitions from clinical enrollment toward data analysis, regulatory engagement, and commercialization readiness. SYMON-II Clinical trials: Bluejay is successfully enrolling across all participating sites in its SYMON™?II multicenter IL-6 monitoring study, with a total of 545 patients enrolled with a target of 750 patients, exceeding initial expectations. All enrollments are under approved IRB protocols. Management believes the scale and diversity of the dataset will meaningfully strengthen the Company's regulatory positioning and support future partner and stakeholder discussions. Current progress materially reduces enrollment execution risk and marks a transition point for the SYMON™? II program. Manufacturing readiness activities continue to advance across multiple parallel workstreams, including antibodies, tooling, analytical validation, and commercial manufacturing infrastructure. Key developments include: Completion of cartridge characterization supporting U.S. commercial production; Completion of monoclonal and polyclonal antibody production, providing supply capacity sufficient for more than 10 million test cartridges; Ongoing fabrication and validation of cartridge and reservoir for FDA submission and commercialization; The Company is also evaluating select material substitutions intended to improve quality consistency and cost efficiency. These efforts are being conducted under defined validation protocols and are actively managed as part of the broader manufacturing readiness plan. Management noted that technology transfer activities are progressing without a single point of failure, supported by parallel execution strategies designed to mitigate timing and scale-up risk. As Bluejay enters 2026, management believes the Company is operating from a materially stronger execution position, with reduced clinical risk and increased focus on value realization through data analysis, regulatory engagement, and commercialization preparedness. Announcement • Oct 10
Bluejay Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $4.5 million. Bluejay Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $4.5 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,250,000
Price\Range: $2
Security Name: Series F Warrants
Security Type: Equity Warrant
Securities Offered: 4,500,000
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 4,500,000
Transaction Features: Registered Direct Offering New Risk • Oct 08
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$6.8m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 44% per year over the past 5 years. Shareholders have been substantially diluted in the past year (351% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.20m market cap). Announcement • May 31
Bluejay Diagnostics, Inc. Announces Cessation of Jason Cook as Chief Technology Officer, Effective on June 4, 2025 As previously reported by Bluejay Diagnostics, Inc. (the “Company”) in its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025, the Company has been discussing the terms and timing of a separation from employment with its Chief Technology Officer, Jason Cook. On May 28, 2025, the Company and Dr. Cook entered into a separation agreement and general release, which will become effective on June 4, 2025 unless earlier revoked by Dr. Cook (the “Separation Agreement”). Under the terms of the Separation Agreement, Dr. Cook will cease employment with the Company on May 30, 2025. Announcement • May 19
Bluejay Diagnostics, Inc., Annual General Meeting, Jun 18, 2025 Bluejay Diagnostics, Inc., Annual General Meeting, Jun 18, 2025. Location: 360massachusetts avenue, suite 203, acton, ma 01720, United States Board Change • Dec 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 1 highly experienced director. Independent Director Gary Gemignani was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. New Risk • Nov 06
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 28% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$8.5m free cash flow). Share price has been highly volatile over the past 3 months (28% average weekly change). Earnings have declined by 45% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 161x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.84m market cap). Announcement • Aug 29
Nasdaq’s Listing Qualifications Staff Extends the Time Period for Bluejay Diagnostics to Regain Compliance with the Minimum Bid Requirement Until February 24, 2025 As previously disclosed in a Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on March 4, 2024, on February 28, 2024, Bluejay Diagnostics, Inc. (the ‘Company’) received a notification letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (‘Nasdaq’) that because the closing bid price for the Company’s common stock, par value $0.0001 (the ‘Common Stock’), had been below $1.00 per share for 30 consecutive business days, the Company was not in with the minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2) (the ‘Minimum Bid Requirement’). On August 28, 2024, Nasdaq’s Listing Qualifications Staff notified the Company that it has extended the time period for the Company to regain compliance with the Minimum Bid Requirement until February 24, 2025. To regain compliance, the closing bid price of the Common Stock must be at least $1.00 or higher for a minimum of ten consecutive business days. The Company intends to continue to actively monitor the closing bid price of the Common Stock and will evaluate available options to regain compliance with the Minimum Bid Requirement. Specifically, the Company has confirmed to Nasdaq that, if necessary, it will implement a reverse stock split of its outstanding common stock (if approved by the Company’s stockholders) to attempt to regain compliance. If the Company does not regain compliance within the additional compliance period, Nasdaq will provide notice that the Common Stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Requirement during the 180-day additional compliance period or maintain compliance with the other Nasdaq listing requirements. New Risk • Jun 17
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$8.1m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings have declined by 50% per year over the past 5 years. Shareholders have been substantially diluted in the past year (184% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.48m market cap). New Risk • May 17
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$8.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$8.1m free cash flow). Earnings have declined by 50% per year over the past 5 years. Shareholders have been substantially diluted in the past year (163% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.55m market cap). Minor Risk Share price has been volatile over the past 3 months (12% average weekly change). New Risk • May 03
New major risk - Revenue and earnings growth Earnings have declined by 56% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 56% per year over the past 5 years. Shareholders have been substantially diluted in the past year (163% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.42m market cap). Minor Risk Share price has been volatile over the past 3 months (12% average weekly change). Announcement • Apr 03
Bluejay Diagnostics, Inc., Annual General Meeting, May 14, 2024 Bluejay Diagnostics, Inc., Annual General Meeting, May 14, 2024, at 13:00 US Eastern Standard Time. Location: 360 Massachusetts Avenue, Suite 203, Acton, Massachusetts Massachusetts United States Announcement • Mar 04
Bluejay Diagnostics Receives Notification Letter from The Nasdaq Stock Market Regarding Non-Compliance with the Minimum Bid Price Requirement Under Nasdaq Listing Rule 5550(a)(2) On February 28, 2024, Bluejay Diagnostics, Inc. (the ‘Company’) received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market (‘Nasdaq’) notifying the Company that the closing bid price for its common stock had been below $1.00 for the previous 30 consecutive business days and that the Company therefore is not in compliance with the minimum bid price requirement for continued inclusion on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification has no immediate effect on the listing of the Company’s common stock on The Nasdaq Capital Market. Under the Nasdaq Listing Rules, the Company has a period of 180 calendar days to regain compliance. To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 or higher for a minimum of ten consecutive business days, and in such case, Nasdaq will provide the Company with written confirmation of compliance. If the Company does not regain compliance by August 26, 2024, the Company may be eligible for an additional 180 calendar days, provided the Company meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except the bid price requirement, and provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period. If the Company is not eligible or it appears to Nasdaq that the Company will not be able to cure the deficiency during the second compliance period, Nasdaq will provide written notice to the Company that the Company’s common stock will be subject to delisting. In the event of such notification, the Company may appeal Nasdaq’s determination to delist its securities, but there can be no assurance that Nasdaq would grant the Company’s request for continued listing. The Company intends to take all reasonable measures available to the Company to achieve compliance to allow for continued listing on The Nasdaq Capital Market. However, there can be no assurance that the Company will be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance with other Nasdaq listing criteria. New Risk • Jan 07
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 361% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (361% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$5.57m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$8.2m net loss in 2 years). Share price has been volatile over the past 3 months (16% average weekly change). Announcement • Dec 27
Bluejay Diagnostics, Inc. Announces Initiation of Multicenter Clinical Study Evaluating Symphony IL-6 in Sepsis Patients Bluejay Diagnostics, Inc. announced the initiation of a multicenter clinical study to evaluate the Symphony IL-6 test in sepsis patients (the SYMON study). The Symphony System is designed to address the need for simple, reliable, rapid, near-patient testing by providing quantitative measurements of specific biomarkers to determine the need for additional patient care and monitoring. The Symphony System was shown in published clinical studies to deliver results directly from whole blood in approximately 20 minutes. This study will use the Symphony IL-6 test to monitor IL-6 concentrations in patients who are diagnosed with sepsis or septic shock and are admitted or intended to be admitted to the ICU. The objective of this study is to establish IL-6 concentrations in these sepsis patients that best predict 28-day mortality. The study design incorporates feedback from the pre-submission meetings with the FDA held earlier this year. Announcement • Nov 22
Bluejay Diagnostics, Inc. has filed a Follow-on Equity Offering. Bluejay Diagnostics, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Prefunded Warrants
Security Type: Equity Warrant
Security Name: Common Warrants
Security Type: Equity Warrant New Risk • Nov 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$9.3m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.3m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (US$3.90m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$8.2m net loss in 2 years). Shareholders have been diluted in the past year (23% increase in shares outstanding). New Risk • Aug 30
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 23% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (31% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (US$7.73m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$7.9m net loss in 2 years). Shareholders have been diluted in the past year (23% increase in shares outstanding). Announcement • Aug 29
Bluejay Diagnostics, Inc. announced that it has received $1.59084 million in funding On August 28, 2023, Bluejay Diagnostics, Inc. closed the transaction. Announcement • Aug 11
Bluejay Diagnostics Regains Compliance with Nasdaq Minimum Bid Price Requirement Bluejay Diagnostics, Inc. announced that on August 8, 2023, it received a notification letter (the "Notification Letter") from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that it had regained compliance with the minimum bid price requirement set in the Nasdaq Listing Rule 5550(a)(2) (the "Nasdaq Capital Market Minimum Bid Price Requirement"). On October 25, 2022, the Company received a notification letter from Nasdaq notifying the Company that it is not in compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock needed to be at least $1.00 or higher for a minimum of ten consecutive business days. On July 24, 2023, the Company executed a reverse stock split of its shares of common stock. Subsequently, on August 8, 2023, the Company received the letter from Nasdaq that, based on the closing bid price of the Company’s common stock having been at least $1.00 per share for the required period, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2) and the minimum bid price deficiency matter previously disclosed by the Company on October 25, 2022 is now closed. Announcement • May 20
Bluejay Diagnostics, Inc. Updates Symphony IL-6 Regulatory Strategy Bluejay Diagnostics, Inc. announced an updated clinical and regulatory strategy for the Symphony IL-6 biomarker test to measure acuity in sepsis patients. The Company plans to modify the clinical trials design to evaluate Symphony IL-6 as a tool to risk stratify hospitalized sepsis patients. Bluejay is adapting its clinical trial design to obtain more patient data, which aligns the regulatory strategy with recent FDA feedback. The trial previously included only severe COVID-19 patients, which have substantively declined since the trial initiated. The Company plans to amend the study to include hospitalized sepsis patients, expanding the inclusion to facilitate a rate of enrollment necessary to maintain the previously disclosed Symphony IL-6 regulatory submission timeline of the first half of 2024. The trial modification may also support an FDA regulatory submission with an initial indication for risk stratification of hospitalized sepsis patients.Bluejay plans to submit a pre-submission application to the FDA presenting the new study design during the second quarter of 2023. The Company believes that Symphony IL-6 has the potential to be an influential tool for the prediction of clinical deterioration in sepsis patients. Symphony IL-6 testing, in conjunction with clinical and other diagnostic findings, may enable healthcare providers to better prioritize appropriate care for those at high risk to help prevent adverse outcomes, and potentially avoid unnecessary investigations and treatments in those at low risk. IL-6 appears as a ‘first responder’ biomarker in the blood during early stages of inflammations and/or infection. A current unmet challenge for healthcare professionals to overcome is the amount of time it takes to identify sepsis in patients and determine disease severity. Existing technologies typically take several hours to deliver IL-6 results, which can delay critical treatment decisions that could improve patient outcomes. The significance of IL-6 testing was highlighted during the COVID-19 pandemic, where elevated IL-6 levels in critically ill patients served as a predictive prognosis biomarker for disease severity. Announcement • May 19
Bluejay Diagnostics, Inc., Annual General Meeting, Jun 14, 2023 Bluejay Diagnostics, Inc., Annual General Meeting, Jun 14, 2023, at 14:00 Eastern Standard Time. Location: 360 Massachusetts Avenue, Suite 203, Acton Massachusetts United States Agenda: To elect six Board nominees to the Board of Directors of the Company, each to serve until the 2023 annual meeting of stockholders of the Company or until such person’s successor is qualified and elected; To approve and adopt an Amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s common stock and adjust the number of shares authorized by the Amended and Restated Certificate of Incorporation; To ratify the appointment of Wolf & Company, P.C. as the Company’s independent registered public accounting firm for the year ending December 31, 2023. Announcement • Oct 31
Bluejay Diagnostics Receives Notification Letter from the Nasdaq Listing Qualifications Staff of the NASDAQ On October 25, 2022, Bluejay Diagnostics, Inc. received a notification letter from the Nasdaq Listing Qualifications Staff of The NASDAQ Stock Market LLC (“Nasdaq”) notifying the Company that the closing bid price for its common stock had been below $1.00 for the previous 30 consecutive business days and that the Company therefore is not in compliance with the minimum bid price requirement for continued inclusion on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification has no immediate effect on the listing of the Company’s common stock on The Nasdaq Capital Market. Under the Nasdaq Listing Rules, the Company has a period of 180 calendar days to regain compliance. To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 or higher for a minimum of ten consecutive business days, and in such case, Nasdaq will provide the Company with written confirmation of compliance. If the Company does not regain compliance by April 24, 2023, the Company may be eligible for an additional 180 calendar days, provided the Company meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq, except the bid price requirement, and will need to provide written notice to Nasdaq of its intention to cure the deficiency during the second compliance period. If the Company is not eligible or it appears to Nasdaq that the Company will not be able to cure the deficiency during the second compliance period, Nasdaq will provide written notice to the Company that the Company’s common stock will be subject to delisting. In the event of such notification, the Company may appeal Nasdaq’s determination to delist its securities, but there can be no assurance that Nasdaq would grant the Company’s request for continued listing. Announcement • Jul 28
Bluejay Diagnostics Presents Positive Clinical Results for its Symphony IL-6 Test at AACC 2022 Bluejay Diagnostics, Inc. 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. 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); and 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. Announcement • Jul 07
Bluejay Diagnostics, Inc. Completes Planned Clinical Studies for Symphony IL-6 Test Bluejay Diagnostics, Inc. announced completion of its previously planned clinical studies for the Symphony IL-6 Test. Results of these studies will be published at the 2022 AACC Annual Scientific Meeting being held July 26th to 28th in Chicago. Announcement • Jun 10
Bluejay Reports FDA Agrees to Consider Its Plan to Pursue A De Novo Regulatory Pathway for the Symphony II-6 Test Bluejay Diagnostics, Inc. announced that the FDA has agreed to consider Bluejay's plan to pursue a De Novo submission for the Symphony IL-6 Test. In written feedback to the January 2022 submission of the FDA pre-submission briefing package, the FDA stated that Bluejay's Symphony IL-6 Test could be considered for the De Novo pathway. Announcement • May 14
Bluejay Diagnostics, Inc., Annual General Meeting, Jun 09, 2022 Bluejay Diagnostics, Inc., Annual General Meeting, Jun 09, 2022, at 14:00 Eastern Daylight. Location: 360 Massachusetts Avenue, Suite 203 Acton Massachusetts United States Agenda: To elect six Board nominees to the Board of Directors of the Company, each to serve until the 2023 annual meeting of stockholders of the Company or until such person’s successor is qualified and elected; to ratify the appointment of Wolf & Company, P.C. as the Company’s independent registered public accounting firm for the year ending December 31, 2022; and to transact any other business that is properly brought before the Annual Meeting or any adjournment or postponement thereof. Announcement • Feb 01
Bluejay Diagnostics, Inc. Announces its Pre-Submission Filing Package for the Symphony IL-6 Test is with the FDA Bluejay Diagnostics, Inc. announced that it has filed a Pre-Submission package for the Symphony IL-6 Test with the U.S. Food and Drug Administration (“FDA” or “the agency”). The purpose of this filing is to request feedback from the agency prior to submitting a medical device marketing application. The pre-submission package will allow the FDA to review and comment on the Company’s plans for clinical trials and analytical testing. Announcement • Jan 14
Bluejay Diagnostics, Inc. Completes 90 Subjects in Multicenter Clinical Study Addressing Rapid IL-6 Test for COVID-19 Patients in Critical Care Bluejay Diagnostics, Inc. reported that it has completed 90 subjects in the prospective multicenter clinical study addressing rapid IL-6 test for COVID-19 patients with critical care. This study performs unique rapid on-site measurement using patient whole blood and positions the Company to move forward with multiple initiatives. Bluejay conducted its multicenter clinical study at two sites at the University of Texas Southwestern Medical Center’s (William P. Clements Hospital and Zale Lipsey Pavilion Hospital), and at Parkland Memorial Hospital, all located in Dallas, Texas. These studies mark the first of their type, in which IL-6 is quantified directly from the whole blood of COVID-19 (SARS-CoV-2 positive) patients in critical care. The results from this multicenter study are currently being prepared for submission for scientific peer review and publication in the Q3:22 timeframe. The study objectives were several fold including: 1) validating the use of unprocessed whole blood for the measurement of IL-6 (compared with the multistep laboratory processing required in current IL-6 measurements); 2) comparison of the Symphony produced measurement values relative to other current standard laboratory tests; 3) generation of the clinical data to support moving the Symphony IL-6 testing into potential commercial use; and 4) producing the results needed to support further approvals through FDA processes. Bluejay intends to file its Pre-Submission application with the FDA in January 2022 for the Symphony IL-6 Test and to initiate an expanded clinical testing program. The results from this clinical program will form the basis of the Company’s planned 510(k) marketing application, intended to be submitted in Q3:22.