WALTHAM, Mass.--(BUSINESS WIRE)--Naveris, Inc., the leader in precision oncology diagnostics for viral-related cancers, today announced that the Centers for Medicare & Medicaid Services (CMS) has designated NavDx, the Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancer, as an Advanced Diagnostic Laboratory Test (ADLT)..

马萨诸塞州沃尔瑟姆（商业新闻短讯）--病毒相关癌症精确肿瘤学诊断的领导者Naveris，Inc.今天宣布，医疗保险和医疗补助服务中心（CMS）已将NavDx（肿瘤组织修饰病毒（TTMV®）-HPV DNA血液检测指定为高级诊断实验室检测（ADLT），该检测有助于检测HPV驱动的癌症。。

Obtaining ADLT status confirms that NavDx meets the highly selective criteria established under the Protecting Access to Medicare Act of 2014 (PAMA). The NavDx test received Medicare coverage in late 2023 for assessing molecular residual disease (MRD) in patients with a history of HPV-driven head and neck cancer..

获得ADLT状态证实NavDx符合2014年《保护获得医疗保险法案》（PAMA）规定的高度选择性标准。NavDx测试于2023年末接受了医疗保险，用于评估有HPV驱动的头颈部癌症病史的患者的分子残留病（MRD）。。

'We commend CMS’s rigorous approach to diagnostic test coverage and reimbursement, which has been crucial for making life-saving technologies like NavDx broadly accessible to patients suffering from cancer,” said Piyush B. Gupta, PhD, Founder, Executive Chairman, and Chief Science and Technology Officer of Naveris.

Naveris创始人、执行主席兼首席科技官Piyush B.Gupta博士说：“我们赞扬CMS在诊断测试覆盖率和报销方面采取的严格方法，这对于使NavDx等救生技术广泛应用于癌症患者至关重要。”。

“This ADLT designation, along with Medicare coverage for NavDx, expands beneficiary access to earlier detection and treatment of cancer, improving patient care and outcomes.'.

“这种ADLT指定以及NavDx的医疗保险覆盖范围，扩大了受益人对癌症早期检测和治疗的机会，改善了患者护理和结果。”。

NavDx is the first and only clinically validated circulating TTMV-HPV DNA blood test. It provides a non-invasive and precise method for detecting HPV-driven cancers before there is clinical or radiographical evidence of disease. Data supporting the clinical validity and utility of NavDx has been published in nearly 20 peer-reviewed publications.

NavDx是第一个也是唯一一个经过临床验证的循环TTMV-HPV DNA血液检测。它提供了一种非侵入性和精确的方法，用于在临床或放射学证据表明疾病之前检测HPV驱动的癌症。支持NavDx临床有效性和实用性的数据已在近20篇同行评审的出版物中发表。

Approval of new ADLT status for NavDx as described by CPT® code 0356U is effective as of April 1, 2024..

CPT®代码0356U所述的NavDx新ADLT状态的批准自2024年4月1日起生效。。

'Receiving ADLT designation for the NavDx test is an exciting next step for Naveris and confirms the unique clinical information provided by NavDx and our TTMV platform,” said James McNally, Chief Executive Officer of Naveris. 'This is a major milestone in the growth of our company and demonstrates our commitment to improving patient access to precision medicine tools for HPV-related cancer surveillance.”.

Naveris首席执行官詹姆斯·麦克纳利（JamesMcNally）表示：“接受NavDx测试的ADLT指定是Naveris令人兴奋的下一步，并证实了NavDx和我们的TTMV平台提供的独特临床信息。这是我们公司发展的一个重要里程碑，表明了我们致力于改善患者获得用于HPV相关癌症监测的精确医学工具的机会。”。

About Naveris

关于Naveris

Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Since its founding in 2017, Naveris has been committed to improving outcomes for the millions of people at risk of developing viral-induced cancers with novel molecular diagnostics that enable earlier cancer detection.

Naveris是一家私人控股的商业阶段精密肿瘤诊断公司，在马萨诸塞州和北卡罗莱纳州设有设施。自2017年成立以来，Naveris一直致力于通过新的分子诊断技术改善数百万患有病毒诱发癌症风险的人群的预后，从而实现早期癌症检测。

The company operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA. For more information on Naveris and the clinical impact of NavDx, please visit www.naveris.com and www.NavDx.com.

该公司运营的高复杂性测试临床实验室得到了美国病理学家学院和纽约州卫生部沃兹沃思中心的认可，并获得了CLIA的认证。有关Naveris和NavDx临床影响的更多信息，请访问www.Naveris.com和www.NavDx.com。

NavDx has not been cleared or approved by the US Food and Drug Administration (FDA)..

NavDx尚未获得美国食品和药物管理局（FDA）的批准或批准。。