正在进行的 Co-Dx PCR MTB 和 HPV 测试的第二阶段临床前研究数据支持推进至临床性能测试
, /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX)（&#34;Co-Dx&#34; 或 &#34;公司&#34;），是一家拥有独特专利平台的分子诊断公司，专注于分子诊断测试的开发，今天宣布 CoSara Diagnostics Pvt. Ltd.（&#34;CoSara&#34;），即 Ambalal Sarabhai Enterprises Limited（ASE Group）与 Co-Dx 之间的合资企业，将参加并在印度马哈拉施特拉邦浦那的康拉德酒店于 12 月 8-10 日举行的 VIROCON 2025 展会设立展位。
<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 目前正在支持公司针对 Co-Dx PCR MTB（结核病）测试和 Co-Dx PCR HPV 多重测试在 Co-Dx PCR 现场检测（PoC）平台上的第二阶段临床前研究。MTB 测试研究的第一阶段包括来自痰液和舌拭子的 354 个临床样本，以提供早期的敏感性和特异性评估，而第二阶段则评估了 211 个痰液样本，与其他测试进行比较评估，以建立对 结核分枝杆菌 检测的一致性。这些研究正在进行中，以准备推进至临床性能测试，这是印度监管机构在提交前所要求的。
针对 8 型 HPV 多重测试的临床前研究第一阶段，旨在识别八种不同人乳头瘤病毒基因型的存在，评估了 286 个临床样本，以验证和优化 Co-Primers® 测试化学。八种基因型中有三种被归类为高风险癌症，在第二阶段，迄今为止已分析了 53 个样本，以促进对三种高风险 HPV 基因型的差异检测，同时应用算法继续进行训练、优化和完善。
公司相信，迄今为止在这两项测试的临床前研究中收集的数据支持推进至临床性能测试，作为监管提交的路径的一部分。
有兴趣了解 CoSara 产品的与会者，包括公司即将推出的 Co-Dx PCR 平台上的 TB 和 HPV 测试，鼓励在 VIROCON 2025 期间前往 CoSara 的展位进行交流和会面。
VIROCON 2025 由印度医学研究委员会 - 国家病毒学研究所（&#34;ICMR-NIV&#34;）主办，今年的主题是 &#34;人类、动物和植物病毒的变化格局：桥接基础科学、创新与公共卫生。&#34; 会议预计将为富有成效的科学讨论和合作提供平台，旨在开发解决方案以遏制威胁人类、动物、植物、水生和环境健康的病毒疫情。
*Co-Dx PCR 平台（包括 PCR Home™、PCR Pro™、移动应用程序及所有相关测试）需接受 FDA 和/或其他监管机构的审查，目前尚未上市销售。
关于 Co-Diagnostics, Inc.: Co-Diagnostics, Inc. 是一家位于犹他州的分子诊断公司，开发、制造和销售先进的诊断技术。公司的技术用于设计用于检测和/或分析核酸分子（DNA 或 RNA）的测试。公司还利用其专有技术为其 Co-Dx PCR 家庭和现场检测平台（需监管审查且目前尚未上市）设计特定测试，并识别用于传染病以外应用的遗传标记。
前瞻性声明： 本新闻稿包含前瞻性声明。前瞻性声明可以通过诸如 &#34;相信&#34;、&#34;期望&#34;、&#34;估计&#34;、&#34;打算&#34;、&#34;可能&#34;、&#34;计划&#34;、&#34;将&#34; 及类似表达，或这些词的否定形式来识别。前瞻性声明包括关于我们 Co-Dx PCR 平台和测试的声明，包括关于潜在或未来临床性能研究、监管提交、产品性能、市场机会或与 Co-Dx PCR 平台及相关测试相关的商业化努力的声明。这些前瞻性声明基于在作出这些声明时存在的事实和条件以及对未来事实和条件的预测。前瞻性声明受到固有的不确定性、风险和情况变化的影响。实际结果可能与这些前瞻性声明所设想或预期的结果有重大差异。阅读本新闻稿的读者应谨慎对待任何前瞻性声明。由于某些风险和不确定性，无法保证任何预期结果会及时发生或根本发生，相关讨论可在我们于 2025 年 3 月 27 日向证券交易委员会（SEC）提交的 10-K 表格年度报告中的风险因素披露以及我们向 SEC 的其他文件中找到。公司不承担更新与本新闻稿中讨论的事项相关的任何前瞻性声明的义务，除非适用证券法要求。
来源 Co-Diagnostics

CODX

Co-Diagnostics, Inc. 宣布其合资企业 CoSara 将参加在印度浦那举行的 VIROCON 2025。CoSara 正在推进 Co-Dx PCR MTB 和 HPV 检测的第二阶段临床前研究，以支持其进入临床性能测试。该活动由 ICMR-NIV 组织，旨在促进科学合作，以应对病毒流行。Co-Diagnostics 的技术正在接受监管审查，尚未上市销售

Ongoing Phase II preclinical study data for Co-Dx PCR MTB and HPV tests support advancement to clinical performance testing
<div class="lb-trans">正在进行的 Co-Dx PCR MTB 和 HPV 测试的第二阶段临床前研究数据支持推进至临床性能测试
</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;），是一家拥有独特专利平台的分子诊断公司，专注于分子诊断测试的开发，今天宣布 CoSara Diagnostics Pvt. Ltd.（&#34;CoSara&#34;），即 Ambalal Sarabhai Enterprises Limited（ASE Group）与 Co-Dx 之间的合资企业，将参加并在印度马哈拉施特拉邦浦那的康拉德酒店于 12 月 8-10 日举行的 VIROCON 2025 展会设立展位。
</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 目前正在支持公司针对 Co-Dx PCR MTB（结核病）测试和 Co-Dx PCR HPV 多重测试在 Co-Dx PCR 现场检测（PoC）平台上的第二阶段临床前研究。MTB 测试研究的第一阶段包括来自痰液和舌拭子的 354 个临床样本，以提供早期的敏感性和特异性评估，而第二阶段则评估了 211 个痰液样本，与其他测试进行比较评估，以建立对 结核分枝杆菌 检测的一致性。这些研究正在进行中，以准备推进至临床性能测试，这是印度监管机构在提交前所要求的。
</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">针对 8 型 HPV 多重测试的临床前研究第一阶段，旨在识别八种不同人乳头瘤病毒基因型的存在，评估了 286 个临床样本，以验证和优化 Co-Primers® 测试化学。八种基因型中有三种被归类为高风险癌症，在第二阶段，迄今为止已分析了 53 个样本，以促进对三种高风险 HPV 基因型的差异检测，同时应用算法继续进行训练、优化和完善。
</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，迄今为止在这两项测试的临床前研究中收集的数据支持推进至临床性能测试，作为监管提交的路径的一部分。
</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">有兴趣了解 CoSara 产品的与会者，包括公司即将推出的 Co-Dx PCR 平台上的 TB 和 HPV 测试，鼓励在 VIROCON 2025 期间前往 CoSara 的展位进行交流和会面。
</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 由印度医学研究委员会 - 国家病毒学研究所（&#34;ICMR-NIV&#34;）主办，今年的主题是 &#34;人类、动物和植物病毒的变化格局：桥接基础科学、创新与公共卫生。&#34; 会议预计将为富有成效的科学讨论和合作提供平台，旨在开发解决方案以遏制威胁人类、动物、植物、水生和环境健康的病毒疫情。
</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™、移动应用程序及所有相关测试）需接受 FDA 和/或其他监管机构的审查，目前尚未上市销售。
</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">关于 Co-Diagnostics, Inc.: Co-Diagnostics, Inc. 是一家位于犹他州的分子诊断公司，开发、制造和销售先进的诊断技术。公司的技术用于设计用于检测和/或分析核酸分子（DNA 或 RNA）的测试。公司还利用其专有技术为其 Co-Dx PCR 家庭和现场检测平台（需监管审查且目前尚未上市）设计特定测试，并识别用于传染病以外应用的遗传标记。
</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">前瞻性声明： 本新闻稿包含前瞻性声明。前瞻性声明可以通过诸如 &#34;相信&#34;、&#34;期望&#34;、&#34;估计&#34;、&#34;打算&#34;、&#34;可能&#34;、&#34;计划&#34;、&#34;将&#34; 及类似表达，或这些词的否定形式来识别。前瞻性声明包括关于我们 Co-Dx PCR 平台和测试的声明，包括关于潜在或未来临床性能研究、监管提交、产品性能、市场机会或与 Co-Dx PCR 平台及相关测试相关的商业化努力的声明。这些前瞻性声明基于在作出这些声明时存在的事实和条件以及对未来事实和条件的预测。前瞻性声明受到固有的不确定性、风险和情况变化的影响。实际结果可能与这些前瞻性声明所设想或预期的结果有重大差异。阅读本新闻稿的读者应谨慎对待任何前瞻性声明。由于某些风险和不确定性，无法保证任何预期结果会及时发生或根本发生，相关讨论可在我们于 2025 年 3 月 27 日向证券交易委员会（SEC）提交的 10-K 表格年度报告中的风险因素披露以及我们向 SEC 的其他文件中找到。公司不承担更新与本新闻稿中讨论的事项相关的任何前瞻性声明的义务，除非适用证券法要求。
</div>SOURCE Co-Diagnostics
<div class="lb-trans">来源 Co-Diagnostics
</div>

Co-Diagnostics 的合资公司 CoSara 将参加 2025 年在印度浦那举行的 VIROCON 大会 | CODX 股票新闻