亿ToOne宣布Medicare覆盖Northstar Select®-动脉网

BillionToOne Announces Medicare Coverage for Northstar Select®

CISION 等信源发布 2025-04-16 21:00

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MENLO PARK, Calif.

门洛帕克，加利福尼亚州

，

April 16, 2025

2025年4月16日

/PRNewswire/ -- BillionToOne, a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, announced today that its comprehensive genomic profiling assay Northstar Select

/PRNewswire/ -- BillionToOne，一家致力于创建强大且准确的检测方法并使其普及到所有人的分子诊断公司，今天宣布其全面的基因组分析检测 Northstar Select。

has met Medicare coverage criteria established by Palmetto GBA, a Medicare administrative contractor that administers the Molecular Diagnostics Services program (MolDx). This coverage, which is effective as of

已符合由管理分子诊断服务计划 (MolDx) 的 Medicare 行政承包商 Palmetto GBA 制定的 Medicare 覆盖标准。此项覆盖自以下日期起生效：

February 14, 2025

2025年2月14日

, ensures Medicare beneficiaries will have access to BillionToOne's liquid biopsy test for cancer therapy selection.

，确保医疗保险受益人能够获得BillionToOne的用于癌症治疗选择的液体活检测试。

Northstar Select

北星精选

is an ultra-sensitive, 84-gene next-generation sequencing (NGS)-based ctDNA panel that helps oncologists identify genomic alterations in patients with advanced solid tumors to guide therapy selection. This non-invasive, blood-based test incorporates BillionToOne's patented Quantitative Counting Template.

是一种超灵敏的、基于84个基因的下一代测序（NGS）ctDNA检测面板，可帮助肿瘤学家识别晚期实体瘤患者的基因组变异，以指导治疗选择。这种非侵入性的血液检测方法结合了BillionToOne的专利定量计数模板。

™

(QCT

（QCT

™

) technology, which enables single-molecule detection and quantification. The comprehensive panel interrogates guideline-recommended alterations and covers 82 genes for SNVs/indels, 19 for copy number amplification, 5 for copy number loss, and 9 for fusions, while also providing microsatellite instability (MSI) status.

）技术，能够实现单分子检测和定量。该综合面板检测指南推荐的变异，覆盖82个基因的SNVs/indels，19个基因的拷贝数扩增，5个基因的拷贝数缺失，以及9个基因的融合，同时提供微卫星不稳定性（MSI）状态。

Designed for any late-stage solid tumors, it offers exceptional sensitivity that detects clinically actionable alterations at levels much lower than other conventional liquid biopsy tests..

专为任何晚期实体瘤设计，它提供了卓越的灵敏度，能够检测到比其他常规液体活检测试低得多水平的临床上可操作的变异。

'Receiving Medicare coverage for Northstar Select

“获得北星巴精选的联邦医疗保险覆盖”

represents a significant milestone and advancement in making the latest precision oncology tools more accessible to patients who need it most,' said

代表了一个重要的里程碑和进步，使得最需要的患者能够更广泛地获取最新的精准肿瘤学工具，

Oguzhan Atay

奥古兹汗·阿塔伊

, Ph.D., Co-Founder and CEO of BillionToOne. 'This coverage further supports the clinical utility of our technology and will help ensure that more patients with advanced cancer can benefit from uncovering more personalized treatment approaches.'

，博士，BillionToOne的联合创始人兼首席执行官。“这一覆盖范围进一步支持了我们技术的临床实用性，并将有助于确保更多晚期癌症患者能够从发现更加个性化的治疗方案中受益。”

The MolDx approval follows rigorous review of evidence demonstrating the test's analytical validity, clinical validity, and clinical utility. Notably, the clinical validation data submitted as part of the MolDx evaluation included a head-to-head concordance study, which demonstrated the superior sensitivity of Northstar Select over other commercially available liquid biopsy tests by identifying 51% more clinically actionable alterations, most of which were found below the comparator assays' 95% limit of detection..

MolDx 的批准是经过对测试的分析有效性、临床有效性和临床实用性进行严格审查后得出的。值得注意的是，作为 MolDx 评估的一部分提交的临床验证数据包括一项头对头的一致性研究，该研究表明 Northstar Select 在识别比其他市售液体活检测试多出 51% 的临床可操作变异方面具有更高的敏感性，其中大部分变异低于对照检测方法 95% 的检测限。

Medicare coverage will apply to eligible beneficiaries with advanced solid tumors who meet the coverage criteria outlined in the MolDx local coverage determination (L38043).

医疗保险覆盖范围将适用于符合MolDx本地覆盖决定（L38043）中概述的覆盖标准的晚期实体瘤合格受益人。

'We believe Northstar Select® offers unique advantages in the field of precision oncology,' said

“我们相信Northstar Select®在精准肿瘤学领域提供了独特的优势，”

Gary Palmer

加里·帕尔默

, Chief Medical Officer, Oncology at BillionToOne. 'Our QCT

，首席医疗官，BillionToOne公司肿瘤学部门。‘我们的QCT

™

technology enables best-in-class sensitivity and precision, enabling oncologists to make more informed treatment decisions by potentially uncovering more clinically actionable alterations that may be missed by other tests.'

技术实现了同级别中最佳的灵敏度和精确度，使肿瘤学家能够通过发现其他测试可能会遗漏的更多具有临床可操作性的变异，从而做出更明智的治疗决策。

Northstar Select

北极星精选

is part of BillionToOne's growing oncology portfolio, which also includes Northstar Response

是 BillionToOne 不断增长的肿瘤学产品组合的一部分，该组合还包括 Northstar Response。

, a tissue-free, methylation-based test designed for monitoring treatment response in patients with advanced cancers. Together, these tests provide oncologists with powerful tools for both therapy selection and treatment monitoring through non-invasive liquid biopsies.

，一种无组织、基于甲基化的检测方法，专为监测晚期癌症患者的治疗反应而设计。这些检测方法共同为肿瘤学家提供了通过非侵入性液体活检进行治疗选择和疗效监测的强大工具。

For more information about Northstar Select

有关 Northstar Select 的更多信息，请参阅

and Northstar Response

和北极星响应

, visit northstaronc.com.

，访问northstaronc.com。

About BillionToOne

关于BillionToOne

Headquartered in

总部位于

Menlo Park, California

门洛帕克，加利福尼亚州

, BillionToOne is a precision diagnostics company on a mission to make molecular diagnostics more accurate, efficient, and accessible for all. The company's single-molecule NGS (smNGS) platform, which includes the patented Quantitative Counting Template (QCT) technology, is the only multiplex methodology that can accurately count DNA molecules at the single-molecule level.

BillionToOne是一家精准诊断公司，致力于使分子诊断更加准确、高效和普及。该公司拥有的单分子NGS（smNGS）平台，包含获得专利的定量计数模板（QCT）技术，是唯一能够在单分子水平上精确计数DNA分子的多重方法。

For more information, please visit .

如需更多信息，请访问。

www.billiontoone.com

。

Media Contact:

媒体联系人：

billiontoone@moxiegrouppr.com

十亿分之一@莫西集团公关.com

Xavier Bower et al., Clinical validation of Northstar Select, a novel liquid biopsy assay for comprehensive genomic profiling of solid tumors. JCO 42, 3072-3072(2024).DOI:10.1200/JCO.2024.42.16_suppl.3072

泽维尔·鲍尔等，《Northstar Select的临床验证：一种用于实体瘤全面基因组分析的新型液体活检方法》，《临床肿瘤学杂志》42卷，3072-3072页（2024年）。DOI:10.1200/JCO.2024.42.16_suppl.3072

SOURCE BillionToOne

来源：BillionToOne

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