The Company expects that the application for OTC clearance will shortly be followed by pursuit of POC clearance, with other tests in the pipeline to meet the needs of a global market

该公司预计，申请OTC许可后不久将进行POC许可，并将进行其他测试以满足全球市场的需求

SALT LAKE CITY, June 14, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the 'Company' or 'Co-Dx'), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that the Company has completed its first U.S. Food and Drug Administration (FDA) application for 510(k) clearance for the Co-Dx™ PCR Pro™ instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use..

盐湖城，2024年6月14日/PRNewswire/--Co Diagnostics，Inc.（纳斯达克代码：CODX）（“公司”或“Co-Dx”）是一家分子诊断公司，拥有开发分子诊断测试的独特专利平台，今天宣布，该公司已完成其第一份美国食品和药物管理局（FDA）的Co-Dx™PCR Pro™仪器510（k）许可申请，以及Co-Dx PCR COVID-19非处方药（OTC）检测申请。。

Co-Diagnostics completed the submission via the FDA's electronic Submissions Template And Resource (eSTAR) system, and have received the acknowledgement from the FDA that the 510(k) application was received. eSTAR serves as a comprehensive resource for medical device manufacturers to standardize and consolidate the necessary information and links needed for 510(k) submission preparation..

。eSTAR是医疗器械制造商的综合资源，用于标准化和整合510（k）提交准备所需的必要信息和链接。。

The Co-Dx PCR platform has been designed to help close the access gap for infectious disease diagnosis by facilitating the widespread decentralization of gold-standard PCR diagnostics, which have historically only been found in high-complexity clinical laboratories. It consists of a compact and robust real-time PCR instrument operated at point-of-care or in at-home settings via an intuitive smartphone interface, with test cups powered by patented Co-Dx Co-Primers® technology..

Co-Dx PCR平台旨在通过促进金标准PCR诊断的广泛分散来帮助缩小传染病诊断的获取差距，而金标准PCR诊断在历史上仅在高度复杂的临床实验室中发现。它由一个紧凑而强大的实时PCR仪器组成，通过直观的智能手机界面在护理点或家庭环境中操作，测试杯由专利的Co-Dx Co-Primers®技术提供动力。。

The Company is also preparing to shortly pursue clearance for the Co-Dx PCR COVID-19 test on the new instrument, to be used for point-of-care testing (POCT).

该公司还准备不久后在新仪器上进行Co-Dx PCR COVID-19检测，用于即时检测（POCT）。

Other diagnostics for the platform in varying stages of development or preparation for clinical evaluations include tests for tuberculosis, human papillomavirus, strep A, and a respiratory multiplex that detects influenza A and B, COVID-19 and RSV in a single test.

该平台在不同开发阶段或临床评估准备阶段的其他诊断包括结核病，人乳头瘤病毒，链球菌A和呼吸多重性检测，可在一次检测中检测甲型和乙型流感，新型冠状病毒19和RSV。

'This FDA application is an important milestone in our Company's growth and represents a crucial step towards closing the gap that separates many patients and communities around the world from gold-standard diagnostics,' said Dwight Egan, Company CEO. 'If granted, we believe that the credibility of 510(k) clearance for diagnostic use would greatly validate the quality of our new platform as we proceed with the completion of tests for other indications and for use in other regions of the world..

该公司首席执行官德怀特·伊根（DwightEgan）说，FDA的这一应用程序是我们公司发展的一个重要里程碑，是缩小世界各地许多患者和社区与金标准诊断之间差距的关键一步如果获得批准，我们相信510（k）诊断使用许可的可信度将极大地验证我们新平台的质量，因为我们将继续完成其他适应症的测试以及在世界其他地区的使用。。

'While we have identified markets for this initial diagnostic offering and we are eager to begin commercialization once cleared to do so, we expect that the other tests to follow will be even more transformative, and we are quickly moving to complete the requirements to initiate clinical evaluations and submit regulatory filings for these tests in their respective target markets.'.

“虽然我们已经确定了这种初始诊断产品的市场，并且一旦获得许可，我们渴望开始商业化，但我们预计接下来的其他测试将更加具有变革性，我们正在迅速完成启动临床评估的要求，并在各自的目标市场提交这些测试的监管文件。”。

*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. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.

*Co-Dx PCR平台（包括PCR Home™、PCR Pro™、移动应用程序和所有相关测试）正在接受FDA和/或其他监管机构的审查，尚未上市。FDA目前正在审查Co-Dx PCR Pro仪器和Co-Dx COVID-19测试。

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 using the detection and/or analysis of nucleic acid molecules (DNA or RNA).

关于Co Diagnostics，Inc.：Co Diagnostics，Inc.，犹他州的一家公司，是一家分子诊断公司，开发，制造和销售最先进的诊断技术。该公司的技术用于使用核酸分子（DNA或RNA）的检测和/或分析设计的测试。

The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform and to locate genetic markers for use in applications other than infectious disease..

该公司还利用其专有技术在家中和即时护理平台上为其Co-Dx PCR设计特定测试，并定位遗传标记以用于传染病以外的应用。。

Forward-Looking Statements:This press release contains forward-looking statements. Forward-looking statements can be identified by words such as 'believes,' 'expects,' 'estimates,' 'intends,' 'may,' 'plans,' 'will' and similar expressions, or the negative of these words. 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.

前瞻性声明：本新闻稿包含前瞻性声明。前瞻性陈述可以用“相信”、“期望”、“估计”、“打算”、“可能”、“计划”、“意志”等词语或这些词语的否定词来识别。此类前瞻性陈述基于陈述时存在的事实和条件以及对未来事实和条件的预测。

Forward-looking statements in this release include statements concerning our intention to pursue clearance for POCT use of the COVID-19 test kit on the new instrument in the near future, and our plans to begin clinical evaluations and complete regulatory submissions for the other tests in our pipeline.

本版本中的前瞻性声明包括关于我们打算在不久的将来在新仪器上获得POCT使用新型冠状病毒检测试剂盒的许可的声明，以及我们计划开始临床评估并完成其他测试的监管提交。

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.

前瞻性陈述受到固有的不确定性、风险和环境变化的影响。实际结果可能与此类前瞻性声明预期或预期的结果存在重大差异。警告本新闻稿的读者不要过度依赖任何前瞻性声明。

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 14, 2024, and in our other filings with the SEC.

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完全发生，有关这些风险和不确定性的讨论可以在我们2024年3月14日提交给证券交易委员会（SEC）的10-K表格年度报告中披露的风险因素以及我们提交给SEC的其他文件中找到。

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..

本公司不承担更新与本新闻稿中讨论的事项有关的任何前瞻性声明的任何义务，除非适用证券法可能要求。。

SOURCE Co-Diagnostics

源Co诊断