正在進行的 Co-Dx PCR MTB 和 HPV 測試的第二階段臨牀前研究數據支持推進至臨牀性能測試
, /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX)（&#34;Co-Dx&#34; 或 &#34;公司&#34;），是一家擁有獨特專利平台的分子診斷公司，專注於分子診斷測試的開發，今天宣佈 CoSara Diagnostics Pvt. Ltd.（&#34;CoSara&#34;），即 Ambalal Sarabhai Enterprises Limited（ASE Group）與 Co-Dx 之間的合資企業，將參加並在印度馬哈拉施特拉邦浦那的康拉德酒店於 12 月 8-10 日舉行的 VIROCON 2025 展會設立展位。
<img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/1856437/Co_Diagnostics_New_Logo_v1.jpg?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://mma.prnewswire.com/media/1856437/Co_Diagnostics_New_Logo_v1.jpg"/>
CoSara 目前正在支持公司針對 Co-Dx PCR MTB（結核病）測試和 Co-Dx PCR HPV 多重測試在 Co-Dx PCR 現場檢測（PoC）平台上的第二階段臨牀前研究。MTB 測試研究的第一階段包括來自痰液和舌拭子的 354 個臨牀樣本，以提供早期的敏感性和特異性評估，而第二階段則評估了 211 個痰液樣本，與其他測試進行比較評估，以建立對 結核分枝桿菌 檢測的一致性。這些研究正在進行中，以準備推進至臨牀性能測試，這是印度監管機構在提交前所要求的。
針對 8 型 HPV 多重測試的臨牀前研究第一階段，旨在識別八種不同人乳頭瘤病毒基因型的存在，評估了 286 個臨牀樣本，以驗證和優化 Co-Primers® 測試化學。八種基因型中有三種被歸類為高風險癌症，在第二階段，迄今為止已分析了 53 個樣本，以促進對三種高風險 HPV 基因型的差異檢測，同時應用算法繼續進行訓練、優化和完善。
公司相信，迄今為止在這兩項測試的臨牀前研究中收集的數據支持推進至臨牀性能測試，作為監管提交的路徑的一部分。
有興趣瞭解 CoSara 產品的與會者，包括公司即將推出的 Co-Dx PCR 平台上的 TB 和 HPV 測試，鼓勵在 VIROCON 2025 期間前往 CoSara 的展位進行交流和會面。
VIROCON 2025 由印度醫學研究委員會 - 國家病毒學研究所（&#34;ICMR-NIV&#34;）主辦，今年的主題是 &#34;人類、動物和植物病毒的變化格局：橋接基礎科學、創新與公共衞生。&#34; 會議預計將為富有成效的科學討論和合作提供平台，旨在開發解決方案以遏制威脅人類、動物、植物、水生和環境健康的病毒疫情。
*Co-Dx PCR 平台（包括 PCR Home™、PCR Pro™、移動應用程序及所有相關測試）需接受 FDA 和/或其他監管機構的審查，目前尚未上市銷售。
關於 Co-Diagnostics, Inc.: Co-Diagnostics, Inc. 是一家位於猶他州的分子診斷公司，開發、製造和銷售先進的診斷技術。公司的技術用於設計用於檢測和/或分析核酸分子（DNA 或 RNA）的測試。公司還利用其專有技術為其 Co-Dx PCR 家庭和現場檢測平台（需監管審查且目前尚未上市）設計特定測試，並識別用於傳染病以外應用的遺傳標記。
前瞻性聲明： 本新聞稿包含前瞻性聲明。前瞻性聲明可以通過諸如 &#34;相信&#34;、&#34;期望&#34;、&#34;估計&#34;、&#34;打算&#34;、&#34;可能&#34;、&#34;計劃&#34;、&#34;將&#34; 及類似表達，或這些詞的否定形式來識別。前瞻性聲明包括關於我們 Co-Dx PCR 平台和測試的聲明，包括關於潛在或未來臨牀性能研究、監管提交、產品性能、市場機會或與 Co-Dx PCR 平台及相關測試相關的商業化努力的聲明。這些前瞻性聲明基於在作出這些聲明時存在的事實和條件以及對未來事實和條件的預測。前瞻性聲明受到固有的不確定性、風險和情況變化的影響。實際結果可能與這些前瞻性聲明所設想或預期的結果有重大差異。閲讀本新聞稿的讀者應謹慎對待任何前瞻性聲明。由於某些風險和不確定性，無法保證任何預期結果會及時發生或根本發生，相關討論可在我們於 2025 年 3 月 27 日向證券交易委員會（SEC）提交的 10-K 表格年度報告中的風險因素披露以及我們向 SEC 的其他文件中找到。公司不承擔更新與本新聞稿中討論的事項相關的任何前瞻性聲明的義務，除非適用證券法要求。
來源 Co-Diagnostics

CODX

Co-Diagnostics, Inc. 宣佈其合資企業 CoSara 將參加在印度浦那舉行的 VIROCON 2025。CoSara 正在推進 Co-Dx PCR MTB 和 HPV 檢測的第二階段臨牀前研究，以支持其進入臨牀性能測試。該活動由 ICMR-NIV 組織，旨在促進科學合作，以應對病毒流行。Co-Diagnostics 的技術正在接受監管審查，尚未上市銷售

Ongoing Phase II preclinical study data for Co-Dx PCR MTB and HPV tests support advancement to clinical performance testing
<div class="lb-trans">正在進行的 Co-Dx PCR MTB 和 HPV 測試的第二階段臨牀前研究數據支持推進至臨牀性能測試
</div>, /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (&#34;Co-Dx&#34; or &#34;the Company&#34;), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that CoSara Diagnostics Pvt. Ltd. (&#34;CoSara&#34;), the joint venture (&#34;JV&#34;) between Ambalal Sarabhai Enterprises Limited (ASE Group) and Co-Dx, will participate and host a booth at VIROCON 2025, taking place December 8-10 at the Conrad Hotel in Pune, Maharashtra, India.
<div class="lb-trans">, /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX)（&#34;Co-Dx&#34; 或 &#34;公司&#34;），是一家擁有獨特專利平台的分子診斷公司，專注於分子診斷測試的開發，今天宣佈 CoSara Diagnostics Pvt. Ltd.（&#34;CoSara&#34;），即 Ambalal Sarabhai Enterprises Limited（ASE Group）與 Co-Dx 之間的合資企業，將參加並在印度馬哈拉施特拉邦浦那的康拉德酒店於 12 月 8-10 日舉行的 VIROCON 2025 展會設立展位。
</div><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/1856437/Co_Diagnostics_New_Logo_v1.jpg" alt="" original-src="https://mma.prnewswire.com/media/1856437/Co_Diagnostics_New_Logo_v1.jpg"/>
CoSara is currently supporting the second phase of the Company's preclinical studies for the Co-Dx PCR MTB (tuberculosis) test and Co-Dx PCR HPV multiplex test on the Co-Dx PCR point-of-care (PoC) platform*. Phase I of the MTB test studies included 354 clinical specimens from sputum and tongue swabs to provide early sensitivity and specificity assessments, while Phase II has evaluated 211 sputum specimens in a comparison evaluation against other tests to establish concordance for Mycobacterium tuberculosis detection. The studies are being conducted in preparation of advancement to clinical performance testing, required by Indian regulatory authorities prior to submission.
<div class="lb-trans">CoSara 目前正在支持公司針對 Co-Dx PCR MTB（結核病）測試和 Co-Dx PCR HPV 多重測試在 Co-Dx PCR 現場檢測（PoC）平台上的第二階段臨牀前研究。MTB 測試研究的第一階段包括來自痰液和舌拭子的 354 個臨牀樣本，以提供早期的敏感性和特異性評估，而第二階段則評估了 211 個痰液樣本，與其他測試進行比較評估，以建立對 結核分枝桿菌 檢測的一致性。這些研究正在進行中，以準備推進至臨牀性能測試，這是印度監管機構在提交前所要求的。
</div>Phase I of the preclinical studies for the 8-type HPV multiplex test, designed to identify the presence of eight different human papillomavirus genotypes, evaluated 286 clinical specimens to validate and optimize the Co-Primers® test chemistry for HPV. Three of the eight genotypes are classified as high-risk for cancer, and in Phase II, 53 specimens have been analyzed to date to facilitate the differential detection of the three high-risk HPV genotypes as the application algorithm continues to be trained, refined and optimized.
<div class="lb-trans">針對 8 型 HPV 多重測試的臨牀前研究第一階段，旨在識別八種不同人乳頭瘤病毒基因型的存在，評估了 286 個臨牀樣本，以驗證和優化 Co-Primers® 測試化學。八種基因型中有三種被歸類為高風險癌症，在第二階段，迄今為止已分析了 53 個樣本，以促進對三種高風險 HPV 基因型的差異檢測，同時應用算法繼續進行訓練、優化和完善。
</div>The Company believes that data gathered thus far in the preclinical studies for both tests support advancement to clinical performance testing, as part of the pathway to regulatory submissions.
<div class="lb-trans">公司相信，迄今為止在這兩項測試的臨牀前研究中收集的數據支持推進至臨牀性能測試，作為監管提交的路徑的一部分。
</div>Attendees interested in learning more about CoSara products, including the TB and HPV tests on the Company's upcoming Co-Dx PCR platform, are encouraged to stop by at VIROCON 2025. CoSara will be available for meetings and interactions at CoSara's booth.
<div class="lb-trans">有興趣瞭解 CoSara 產品的與會者，包括公司即將推出的 Co-Dx PCR 平台上的 TB 和 HPV 測試，鼓勵在 VIROCON 2025 期間前往 CoSara 的展位進行交流和會面。
</div>VIROCON 2025 is organized by the India Council of Medical Research - National Institute of Virology (&#34;ICMR-NIV&#34;), with this year's theme being &#34;Changing Landscape in Human, Animal, and Plant Viruses: Bridging Basic Science, Innovations and Public Health.&#34; The conference is expected to provide a platform for productive scientific deliberations and collaborations aimed at developing solutions to contain the viral epidemics that threaten human, animal, plant, aquatic and environmental health.
<div class="lb-trans">VIROCON 2025 由印度醫學研究委員會 - 國家病毒學研究所（&#34;ICMR-NIV&#34;）主辦，今年的主題是 &#34;人類、動物和植物病毒的變化格局：橋接基礎科學、創新與公共衞生。&#34; 會議預計將為富有成效的科學討論和合作提供平台，旨在開發解決方案以遏制威脅人類、動物、植物、水生和環境健康的病毒疫情。
</div>*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
<div class="lb-trans">*Co-Dx PCR 平台（包括 PCR Home™、PCR Pro™、移動應用程序及所有相關測試）需接受 FDA 和/或其他監管機構的審查，目前尚未上市銷售。
</div>About Co-Diagnostics, Inc.: Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed to detect and/or analyze nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform (subject to regulatory review and not currently for sale) and to identify genetic markers for use in applications other than infectious disease.
<div class="lb-trans">關於 Co-Diagnostics, Inc.: Co-Diagnostics, Inc. 是一家位於猶他州的分子診斷公司，開發、製造和銷售先進的診斷技術。公司的技術用於設計用於檢測和/或分析核酸分子（DNA 或 RNA）的測試。公司還利用其專有技術為其 Co-Dx PCR 家庭和現場檢測平台（需監管審查且目前尚未上市）設計特定測試，並識別用於傳染病以外應用的遺傳標記。
</div>Forward-Looking Statements: This press release contains forward-looking statements. Forward-looking statements can be identified by words such as &#34;believes,&#34; &#34;expects,&#34; &#34;estimates,&#34; &#34;intends,&#34; &#34;may,&#34; &#34;plans,&#34; &#34;will&#34; and similar expressions, or the negative of these words. Forward-looking statements include statements made with respect to our Co-Dx PCR platform and tests, including statements about potential or future clinical performance studies, regulatory submissions, product performance, market opportunities, or commercialization efforts related to the Co-Dx PCR platform and associated tests. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 27, 2025, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
<div class="lb-trans">前瞻性聲明： 本新聞稿包含前瞻性聲明。前瞻性聲明可以通過諸如 &#34;相信&#34;、&#34;期望&#34;、&#34;估計&#34;、&#34;打算&#34;、&#34;可能&#34;、&#34;計劃&#34;、&#34;將&#34; 及類似表達，或這些詞的否定形式來識別。前瞻性聲明包括關於我們 Co-Dx PCR 平台和測試的聲明，包括關於潛在或未來臨牀性能研究、監管提交、產品性能、市場機會或與 Co-Dx PCR 平台及相關測試相關的商業化努力的聲明。這些前瞻性聲明基於在作出這些聲明時存在的事實和條件以及對未來事實和條件的預測。前瞻性聲明受到固有的不確定性、風險和情況變化的影響。實際結果可能與這些前瞻性聲明所設想或預期的結果有重大差異。閲讀本新聞稿的讀者應謹慎對待任何前瞻性聲明。由於某些風險和不確定性，無法保證任何預期結果會及時發生或根本發生，相關討論可在我們於 2025 年 3 月 27 日向證券交易委員會（SEC）提交的 10-K 表格年度報告中的風險因素披露以及我們向 SEC 的其他文件中找到。公司不承擔更新與本新聞稿中討論的事項相關的任何前瞻性聲明的義務，除非適用證券法要求。
</div>SOURCE Co-Diagnostics
<div class="lb-trans">來源 Co-Diagnostics
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Co-Diagnostics 的合資公司 CoSara 將參加 2025 年在印度浦那舉行的 VIROCON 大會 | CODX 股票新聞