Labcorp推出分子残留病灶和液体活检解决方案-动脉网

Labcorp Launches Molecular Residual Disease and Liquid Biopsy Solutions

CISION 等信源发布 2025-04-23 19:00

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Labcorp

Plasma Detect™ now available for clinical use to assess risk of recurrence in stage III colon cancer patients

Plasma Detect™ 现已可用于临床，评估III期结肠癌患者复发风险。

FDA-authorized liquid biopsy assay PGDx elio

FDA授权的液体活检分析PGDx elio

plasma focus™ Dx now available to support treatment selection

等离子体聚焦™ Dx现已可用，以支持治疗选择。

BURLINGTON, N.C.

北卡罗来纳州伯灵顿

，

April 23, 2025

2025年4月23日

/PRNewswire/ --

/美通社/ --

Labcorp

(NYSE:

（纽约证券交易所：

), a global leader of innovative and comprehensive laboratory services, announced today the expansion of its precision oncology portfolio with two solutions:

），一家全球领先的创新和全面的实验室服务提供商，今天宣布了其精准肿瘤学产品组合的扩展，推出了两种解决方案：

Labcorp Plasma Detect

Labcorp 血浆检测

for clinical use to help assess the risk of disease recurrence in stage III colon cancer patients, and the availability of

用于临床评估III期结肠癌患者疾病复发的风险，以及可用性

PGDx elio plasma focus Dx

PGDx elio 血浆聚焦诊断

, the first and only kitted, pan-solid tumor liquid biopsy test authorized by the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from targeted treatments.

，这是美国食品药品监督管理局（FDA）授权的首个也是唯一一个用于识别可能受益于靶向治疗的患者的泛实体瘤液体活检测试。

继续阅读

Photo courtesy of Labcorp

照片由Labcorp提供

'Labcorp is dedicated to providing oncologists with a comprehensive portfolio of innovative solutions that enable precise, timely and personalized treatment decisions,' said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. 'With the expansion of our portfolio to include Labcorp Plasma Detect for clinical use and the availability of PGDx elio plasma focus Dx to support patient treatment selection, we're advancing care across the oncology spectrum, solidifying our commitment to transforming cancer diagnostics and improving patient outcomes.'.

“Labcorp致力于为肿瘤科医生提供一套全面的创新解决方案，以实现精准、及时和个性化的治疗决策，”Labcorp肿瘤学副总裁兼医学主管Shakti Ramkissoon博士表示。“随着我们的产品组合扩展至包括用于临床的Labcorp Plasma Detect，以及支持患者治疗选择的PGDx elio plasma focus Dx的可用性，我们正在推动整个肿瘤领域的护理进步，坚定我们对变革癌症诊断和改善患者预后的承诺。”

Labcorp Plasma Detect: Advanced Risk Assessment for Colon Cancer Patients

Labcorp 血浆检测：结肠癌患者的高级风险评估

Stage III colon cancer has a nearly

第三期结肠癌几乎有

30%

recurrence rate within five years.

五年内的复发率。

Labcorp Plasma Detect

Labcorp血浆检测

is a blood-based test using whole-genome sequencing (

是一种基于血液的全基因组测序测试 (

WGS

) to detect circulating tumor DNA (

) 来检测循环肿瘤 DNA (

ctDNA

循环肿瘤DNA

), indicating the presence of molecular residual disease (

），表明存在分子残留病（

MRD

市场需求文档

）。

Patients who are

患者们

MRD-positive

MRD阳性

after cancer treatment have a higher risk of recurrence and a poorer prognosis.

癌症治疗后复发的风险更高，预后更差。

Labcorp's

Labcorp的

test detects cancer recurrence risk that conventional methods might miss, helping to identify patients who could benefit from additional treatment or therapy.

测试检测到传统方法可能遗漏的癌症复发风险，有助于识别可能从额外治疗或疗法中受益的患者。

Key Features of Labcorp Plasma Detect:

Labcorp Plasma Detect 的主要特点：

The test is Labcorp's first tumor-informed MRD solution for clinical use to support recurrence risk stratification. Labcorp Plasma Detect

该测试是 Labcorp 首个用于临床的肿瘤知情 MRD 解决方案，旨在支持复发风险分层。Labcorp Plasma Detect

launched in 2024

2024年推出

for biopharma use to support exploratory and investigational studies.

用于支持生物制药的探索性和研究性研究。

The test combines a WGS approach, without the need for a bespoke panel, with proprietary bioinformatics to deliver ctDNA detection down to a limit of detection (LOD95) of 0.005%.

该测试结合了全基因组测序（WGS）方法，无需定制面板，并通过专有生物信息学技术，实现低至0.005%检测限（LOD95）的循环肿瘤DNA（ctDNA）检测。

Results are available approximately 14 days after Labcorp receives the initial sample, and seven days for subsequent monitoring time points for each patient.

结果在Labcorp收到初始样本后大约14天可用，而每个患者后续监测时间点则需7天。

Labcorp Plasma Detect is currently being evaluated in more than 10 clinical studies in the U.S. and internationally to assess MRD across various cancer types.

Labcorp Plasma Detect目前在美国和国际上超过10项临床研究中进行评估，以检测各种癌症类型的MRD。

Labcorp Plasma Detect will be offered initially through an

Labcorp Plasma Detect 最初将通过以下方式提供：

Early Experience Program

早期经验计划

, with the intent to expand availability more broadly.

，并意图更广泛地扩大供应。

PGDx elio plasma focus Dx Now Available for Use to Aid in Treatment Selection

PGDx elio plasma focus Dx 现已可用，可帮助选择治疗方案。

PGDx elio plasma focus Dx

PGDx elio 血浆聚焦 Dx

is the first and only

是第一个也是唯一一个

kitted

已装备

pan-solid tumor liquid biopsy test to receive

泛实体瘤液体活检测试获批

De Novo authorization from the FDA

FDA 的 De Novo 授权

. This assay provides

.该测定提供

oncologists

肿瘤科医生

with a validated tool to assess various solid tumors for targeted treatment selection – all from a simple blood draw.

通过一项经过验证的工具，可以评估各种实体肿瘤以选择靶向治疗方案——全部来自简单的抽血。

Key Features of PGDx elio plasma focus Dx:

PGDx elio plasma focus Dx的主要特点：

The kitted model allows clinical laboratories and hospitals to retain control over patient specimens and data for research, care management and other clinical purposes.

该成套模型允许临床实验室和医院为研究、护理管理和其它临床目的保留对患者样本和数据的控制。

As an FDA-authorized assay, PGDx elio plasma focus Dx requires only on-site verification – as opposed to a full validation – enabling more rapid implementation.

作为FDA授权的检测方法，PGDx elio plasma focus Dx仅需现场验证，而非全面验证，从而能够更快地实施。

Once implemented, this rapid, scalable liquid biopsy genomic test provides actionable findings within a 4-to-5-day turnaround time, from isolated nucleic acid to variant report.

一旦实施，这种快速、可扩展的液体活检基因组测试能够在4到5天的时间内提供可操作的发现，从分离的核酸到变异报告。

As part of the PGDx elio platform, the kitted model is compatible with FDA-cleared

作为PGDx elio平台的一部分，该套件模型与FDA批准的兼容。

PGDx elio™ tissue complete

PGDx elio™ 组织完整解决方案

, enabling seamless, in-house tissue-to-liquid reflexing and efficient comprehensive genomic profiling workflows.

，实现无缝的内部组织到液体的反射和高效的综合基因组分析工作流程。

Labcorp at the American Association for Cancer Research (AACR) 2025 Annual Meeting

Labcorp在2025年美国癌症研究协会（AACR）年会上

Labcorp

will present key studies at the

将在会议上展示关键研究

AACR

美国癌症研究协会

2025 Annual Meeting, including the clinical use of

2025年年会，包括临床使用在内的相关内容

Labcorp

Plasma Detect and performance of

等离子体检测与性能

PGDx elio

plasma focus

聚焦等离子体

_dx_

。

To learn more, or to connect with Labcorp at AACR in

要了解更多信息，或在AACR与Labcorp联系，请访问

Chicago

芝加哥

, visit

，访问

https://oncology.labcorp.com/american-association-cancer-research-annual-meeting-2025

https://oncology.labcorp.com/美国癌症研究协会年会2025

For more information about Labcorp's Oncology solutions, contact us at

有关 Labcorp 的肿瘤学解决方案的更多信息，请联系我们

https://oncology.labcorp.com/contact-us

About Labcorp

关于Labcorp

Labcorp

(NYSE:

（纽约证券交易所：

左高（Left High）

) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities.

）是创新和全面实验室服务的全球领导者，帮助医生、医院、制药公司、研究人员和患者做出清晰而自信的决策。我们通过无与伦比的诊断和药物开发实验室能力提供见解并推动科学发展，以改善健康状况和生活质量。

The company's nearly 70,000 employees serve clients in approximately 100 countries, provided support for more than 75% of the new drugs and therapeutic products approved in 2024 by the FDA, and perform more than 700 million tests annually for patients around the world. Learn more about us at .

公司近70,000名员工为大约100个国家的客户提供服务，为2024年FDA批准的新药和治疗产品中的75%以上提供了支持，并且每年为全球患者进行超过7亿次检测。欲了解更多信息，请访问。

www.labcorp.com

。

我

The term MRD is often used interchangeably between molecular residual disease and minimal residual disease. Labcorp Plasma Detect detects molecular residual disease, which is defined as the subclinical presence of a cancer-associated biomarker indicating a high risk of recurrence, which cannot be detected by standard imaging techniques.

MRD 一词常在分子残留病灶和微小残留病灶之间互换使用。Labcorp Plasma Detect 检测的是分子残留病灶，其定义为存在与癌症相关的生物标志物的亚临床表现，表明有高复发风险，且无法通过标准成像技术检测到。

MRD terminology is in accordance with the .

MRD术语符合。

BLOODPAC Consortium

BLOODPAC联盟

。

SOURCE Labcorp

源实验室公司

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