<p>馬薩諸塞州阿克頓，2025 年 12 月 29 日（GLOBE NEWSWIRE）-- Bluejay Diagnostics, Inc.（納斯達克：BJDX）（“Bluejay” 或 “公司”）宣佈已完成針對白細胞介素-6（IL-6）的多克隆和單克隆抗體的商業規模生產，該生物標誌物與炎症和重症護理應用相關。</p>
<p>公司表示，多克隆和單克隆抗體均符合內部性能標準，包括反應性，可用於用於臨牀和潛在未來商業應用的 Symphony™卡匣製造。</p>
<p>Bluejay 已使用第三方和內部開發的免疫原生成多克隆抗體。公司打算利用其專有免疫原生產的抗體進行持續的開發活動，以支持其知識產權戰略。公司生產的單克隆抗體，指定用於 IL-6 檢測中的檢測抗體，已根據迄今為止進行的內部測試顯示出可接受的結合性、特異性和信號性能特徵，適用於其預期的診斷用途。</p>
<p>根據當前的抗體庫存，Bluejay 估計其有足夠的材料支持生產超過九百萬個用於臨牀和商業製造目的的 Symphony 卡匣。公司還建立了根據需要生產額外抗體的能力。</p>
<p><em>公司指出，Symphony™仍在開發中，需進一步驗證、監管審查和批准，無法保證這些活動的時間或成功。</em></p>
<p><strong>關於 Bluejay Diagnostics：</strong></p>
<p>Bluejay Diagnostics, Inc.是一家醫療診斷公司，專注於利用其 Symphony 系統改善患者結果，該系統是一種經濟高效、快速、近患者的檢測系統，用於膿毒症分流和疾病進展監測。Bluejay 尚未獲得 Symphony 系統的監管批准，我們需要從美國食品藥品監督管理局獲得監管授權，才能在美國將 Symphony 作為診斷產品進行市場銷售。Bluejay 的首個產品候選者是針對膿毒症的 IL-6 檢測，旨在提供約 20 分鐘內從 “樣本到結果” 的準確、可靠結果，以幫助醫療專業人員做出更早和更好的分流/治療決策。更多信息請訪問 www.bluejaydx.com。</p>
<p><strong>前瞻性聲明：</strong></p>
<p>本新聞稿包含公司認為是《私人訴訟改革法》意義上的 “前瞻性聲明” 的陳述。本新聞稿中的前瞻性聲明包括但不限於與 Bluejay 的 Symphony 平台商業化狀態相關的陳述。前瞻性聲明可以通過諸如 “預期”、“相信”、“估計”、“期望”、“打算”、“可能”、“計劃”、“項目”、“尋求”、“應該”、“建議”、“將” 等類似表達來識別。公司基於其對未來事件的當前預期和預測作出這些前瞻性聲明，然而，實際結果或事件可能與公司所披露或暗示的計劃、意圖和期望有實質性差異。這些聲明僅為預測，涉及已知和未知的風險、不確定性及其他因素，包括市場和其他條件，以及在我們向證券交易委員會（“SEC”）提交的 2024 財年 10-K 表格第 1A 項 “風險因素” 中討論的因素，以及在其 2025 年 3 月 31 日、2025 年 6 月 30 日和 2025 年 9 月 30 日的 10-Q 季度報告第 1A 項 “風險因素” 中討論的因素。您不應對這些前瞻性聲明過於依賴，因為它們受到風險和不確定性的影響，未來期間的實際結果和表現可能不會發生，或可能與本發佈中前瞻性聲明所暗示的任何未來結果或表現有實質性不同。本新聞稿的內容截至上述日期。公司沒有義務更新任何前瞻性聲明，無論是由於新信息、未來事件還是其他原因，除非法律要求。公司明確聲明不承擔更新或修訂本聲明中任何前瞻性聲明的義務，以反映公司對結果的期望或任何未來事件的變化，除非法律要求。</p>
<p><strong>投資者聯繫：</strong></p>
<p>Neil Dey</p>
<p>Bluejay Diagnostics, Inc.</p>
<p>neil.dey@bluejaydx.com</p>
<p>978-631-0310</p>
<p><strong><em>網站：www.bluejaydx.com</em></strong></p>
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<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/ODVmODhmYTctYzMxNy00MjA4LThhMmMtZWY0Nzc4ZmQ1Yjk4LTEyMzQ3MDAtMjAyNS0xMi0yOS1lbg==/tiny/Bluejay-Diagnostics-Inc-.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/ODVmODhmYTctYzMxNy00MjA4LThhMmMtZWY0Nzc4ZmQ1Yjk4LTEyMzQ3MDAtMjAyNS0xMi0yOS1lbg==/tiny/Bluejay-Diagnostics-Inc-.png"/></p>

BJDX

<p>Bluejay Diagnostics, Inc. 已完成 IL-6 抗體的商業規模生產，滿足臨牀應用的內部性能標準。公司估計庫存足夠生產超過九百萬個 Symphony 碳墨盒。Symphony 系統旨在快速檢測膿毒症，目前仍在開發中，需獲得 FDA 批准後才能上市。Bluejay 強調，發佈中的前瞻性聲明受到風險和不確定性的影響，實際結果可能與預期有所不同</p>

<p>ACTON, Mass., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”) announced that it has completed commercial-scale production of both polyclonal and monoclonal antibodies targeting interleukin-6 (IL-6), a biomarker relevant to inflammatory and critical-care applications.</p>
<div class="lb-trans"><p>馬薩諸塞州阿克頓，2025 年 12 月 29 日（GLOBE NEWSWIRE）-- Bluejay Diagnostics, Inc.（納斯達克：BJDX）（“Bluejay” 或 “公司”）宣佈已完成針對白細胞介素-6（IL-6）的多克隆和單克隆抗體的商業規模生產，該生物標誌物與炎症和重症護理應用相關。</p>
</div><p>The Company stated that both polyclonal and monoclonal antibodies met internal performance criteria, including reactivity, for use in Symphony™ cartridge manufacturing intended for clinical and potential future commercial applications.</p>
<div class="lb-trans"><p>公司表示，多克隆和單克隆抗體均符合內部性能標準，包括反應性，可用於用於臨牀和潛在未來商業應用的 Symphony™卡匣製造。</p>
</div><p>Bluejay has generated polyclonal antibodies using both third-party and internally developed immunogens. The Company intends to utilize antibodies produced from its proprietary immunogen for ongoing development activities in support of its intellectual-property strategy. The monoclonal antibodies produced by the Company, designated for use as detection antibodies in the IL-6 assay, have demonstrated acceptable binding, specificity, and signal performance characteristics for their intended diagnostic use, based on internal testing conducted to date.</p>
<div class="lb-trans"><p>Bluejay 已使用第三方和內部開發的免疫原生成多克隆抗體。公司打算利用其專有免疫原生產的抗體進行持續的開發活動，以支持其知識產權戰略。公司生產的單克隆抗體，指定用於 IL-6 檢測中的檢測抗體，已根據迄今為止進行的內部測試顯示出可接受的結合性、特異性和信號性能特徵，適用於其預期的診斷用途。</p>
</div><p>Based on current antibody inventory, Bluejay estimates that it has sufficient material to support production of more than nine million Symphony cartridges for clinical and commercial manufacturing purposes. The Company has also established the capability to produce additional antibodies as needed.</p>
<div class="lb-trans"><p>根據當前的抗體庫存，Bluejay 估計其有足夠的材料支持生產超過九百萬個用於臨牀和商業製造目的的 Symphony 卡匣。公司還建立了根據需要生產額外抗體的能力。</p>
</div><p><em>The Company noted that Symphony™ remains under development and subject to further validation, regulatory review, and clearance, and that there can be no assurance regarding the timing or success of these activities.</em></p>
<div class="lb-trans"><p><em>公司指出，Symphony™仍在開發中，需進一步驗證、監管審查和批准，無法保證這些活動的時間或成功。</em></p>
</div><p><strong>About Bluejay Diagnostics:</strong></p>
<div class="lb-trans"><p><strong>關於 Bluejay Diagnostics：</strong></p>
</div><p>Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression. Bluejay does not yet have regulatory clearance for the Symphony System, and we will need to receive regulatory authorization from the U.S. Food and Drug Administration before Symphony can be marketed as a diagnostic product in the United States. Bluejay’s first product candidate, an IL-6 Test for sepsis, 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.</p>
<div class="lb-trans"><p>Bluejay Diagnostics, Inc.是一家醫療診斷公司，專注於利用其 Symphony 系統改善患者結果，該系統是一種經濟高效、快速、近患者的檢測系統，用於膿毒症分流和疾病進展監測。Bluejay 尚未獲得 Symphony 系統的監管批准，我們需要從美國食品藥品監督管理局獲得監管授權，才能在美國將 Symphony 作為診斷產品進行市場銷售。Bluejay 的首個產品候選者是針對膿毒症的 IL-6 檢測，旨在提供約 20 分鐘內從 “樣本到結果” 的準確、可靠結果，以幫助醫療專業人員做出更早和更好的分流/治療決策。更多信息請訪問 www.bluejaydx.com。</p>
</div><p><strong>Forward-Looking Statements:</strong></p>
<div class="lb-trans"><p><strong>前瞻性聲明：</strong></p>
</div><p>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 in this press release include, without limitation, statements pertaining to the status of Bluejay’s commercialization of its Symphony platform. 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. 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 market and other conditions and those discussed under item 1A. “Risk Factors” in our Form 10-K for the fiscal year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, and in Part II, Item 1A, “Risk Factors” in its Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2025, June 30, 2025 and September 30, 2025, filed with the SEC on May 13, 2025, August 7, 2025 and November 7, 2025, respectively. You should not place undue reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may not occur or 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, except as required by law. The Company expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the Company’s expectations of results or any future change in events, except as required by law.</p>
<div class="lb-trans"><p>本新聞稿包含公司認為是《私人訴訟改革法》意義上的 “前瞻性聲明” 的陳述。本新聞稿中的前瞻性聲明包括但不限於與 Bluejay 的 Symphony 平台商業化狀態相關的陳述。前瞻性聲明可以通過諸如 “預期”、“相信”、“估計”、“期望”、“打算”、“可能”、“計劃”、“項目”、“尋求”、“應該”、“建議”、“將” 等類似表達來識別。公司基於其對未來事件的當前預期和預測作出這些前瞻性聲明，然而，實際結果或事件可能與公司所披露或暗示的計劃、意圖和期望有實質性差異。這些聲明僅為預測，涉及已知和未知的風險、不確定性及其他因素，包括市場和其他條件，以及在我們向證券交易委員會（“SEC”）提交的 2024 財年 10-K 表格第 1A 項 “風險因素” 中討論的因素，以及在其 2025 年 3 月 31 日、2025 年 6 月 30 日和 2025 年 9 月 30 日的 10-Q 季度報告第 1A 項 “風險因素” 中討論的因素。您不應對這些前瞻性聲明過於依賴，因為它們受到風險和不確定性的影響，未來期間的實際結果和表現可能不會發生，或可能與本發佈中前瞻性聲明所暗示的任何未來結果或表現有實質性不同。本新聞稿的內容截至上述日期。公司沒有義務更新任何前瞻性聲明，無論是由於新信息、未來事件還是其他原因，除非法律要求。公司明確聲明不承擔更新或修訂本聲明中任何前瞻性聲明的義務，以反映公司對結果的期望或任何未來事件的變化，除非法律要求。</p>
</div><p><strong>Investor Contact:</strong></p>
<div class="lb-trans"><p><strong>投資者聯繫：</strong></p>
</div><p>Neil Dey</p>
<div class="lb-trans"><p>Neil Dey</p>
</div><p>Bluejay Diagnostics, Inc.</p>
<div class="lb-trans"><p>Bluejay Diagnostics, Inc.</p>
</div><p>neil.dey@bluejaydx.com</p>
<div class="lb-trans"><p>neil.dey@bluejaydx.com</p>
</div><p>978-631-0310</p>
<div class="lb-trans"><p>978-631-0310</p>
</div><p><strong><em>Website: www.bluejaydx.com</em></strong></p>
<div class="lb-trans"><p><strong><em>網站：www.bluejaydx.com</em></strong></p>
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Bluejay Diagnostics 宣佈完成商業規模的 IL-6 抗體生產 | BJDX 股票新聞