Investing News NetworkApril 10, 2024Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce the appointment of international Contract Research Organization (CRO), Lindus Health, as a key partner for its U.S. clinical trials program. HighlightsCLEO has appointed U.S.-based Lindus Health to manage U.S.

投资新闻网2024年4月10日卵巢癌诊断公司Cleo diagnostics Limited（ASX:COV）（Cleo，或该公司）很高兴宣布任命国际合同研究组织（CRO）Lindus Health为其美国临床试验计划的关键合作伙伴。HighlightsCLEO已任命总部位于美国的Lindus Health管理美国。

clinical trials for its revolutionary ovarian cancer blood testLindus Health is a leader in clinical trial management for the med-tech sector, with a strong record of timely and successful trial executionCLEO's U.S. study will prospectively recruit up to 500 patients commencing next month and will verify the performance of CLEO's pre-surgical ovarian cancer test for FDA regulatory approval.

革命性卵巢癌血液检测的临床试验Lindus Health是医学技术领域临床试验管理的领导者，拥有及时成功的试验执行记录。CLEO的美国研究将从下个月开始前瞻性招募多达500名患者，并将验证CLEO手术前卵巢癌检测的性能，以获得FDA监管部门的批准。

U.S. Ovarian Cancer Clinical TrialsAs a part of CLEO’s U.S. market access program, the Company will partner with U.S.-based CRO, Lindus Health, appointing it to manage the successful execution of its ovarian cancer U.S. clinical trials. Lindus Health was chosen following a robust process to identify a partner with the proven experience, technology and high standards capable of delivering on CLEO’s objectives.Lindus Health specialises in collaborating with med-tech companies to conduct clinical trials worldwide, leveraging their innovative patient recruitment and trial management technology platform to deliver efficient and timely outcomes.Comprehensive U.S.

U、 作为CLEO美国市场准入计划的一部分，该公司将与美国CRO Lindus Health合作，任命其管理卵巢癌美国临床试验的成功执行。Lindus Health是经过一个强有力的过程选择的，以确定一个具有成熟经验、技术和高标准的合作伙伴，能够实现CLEO的目标。Lindus Health专门与医学技术公司合作，在全球范围内进行临床试验，利用其创新的患者招募和试验管理技术平台，提供高效及时的结果。综合美国。

patient data is essential for a successful regulatory application through the Food and Drug Administration (FDA). CLEO will leverage Lindus Health’s expertise to execute a cost-effective and rapid clinical study that will support its subsequent FDA 510(k) application. The study will benchmark CLEO’s pre-surgical ovarian cancer triage test and provide the core data requiremen.

患者数据对于通过食品和药物管理局（FDA）成功进行监管应用至关重要。CLEO将利用Lindus Health的专业知识进行一项具有成本效益且快速的临床研究，以支持其随后的FDA 510（k）应用。该研究将对CLEO的术前卵巢癌分诊测试进行基准测试，并提供所需的核心数据。