罗氏获得FDA 510(k)对新cobas® eplex呼吸道病原体面板3的批准，使实验室能够根据当地患者的需求定制呼吸道检测-动脉网

Roche receives FDA 510(k) clearance for new cobas® eplex respiratory pathogen panel 3, enabling labs to customize respiratory testing for local patient needs

CISION 等信源发布 2026-11-02 22:30

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The new cobas

全新cobas

注册商标

eplex RP3 panel detects up to 19 viruses and bacteria, with newly added

eplex RP3 面板可检测多达 19 种病毒和细菌，新增

Bordetella pertussis

百日咳博德特氏菌

and improved inclusivity of influenza A and SARS-CoV-2 strains, from a single sample to inform timely patient management.

并提高了对甲型流感和SARS-CoV-2毒株的包容性，通过单个样本为患者管理提供及时信息。

Laboratories can optimize resources with up to five flexible panel configurations tailored to local disease prevalence and patient needs, enabled by cobas® eplex system software version 3.0 or higher.

借助 cobas® eplex 系统软件 3.0 或更高版本，实验室可以根据当地疾病流行情况和患者需求，通过多达五种灵活的检测组合配置来优化资源。

The streamlined workflow enhances operational efficiency, requiring less than one minute of hands-on time and delivering results in under two hours.

精简的工作流程提升了运营效率，仅需不到一分钟的人工操作时间，并在两小时内提供结果。

The test expands the existing capabilities of cobas® eplex respiratory pathogen panel 2 (EUA).

该检测扩展了cobas® eplex呼吸道病原体面板2（EUA）的现有功能。

INDIANAPOLIS

印第安纳波利斯

，

Nov. 2, 2026

2026年11月2日

/PRNewswire/ -- Roche announced today the U.S. Food and Drug Administration (FDA) 510(k) clearance of the

/美通社/ -- 罗氏今日宣布，美国食品药品监督管理局（FDA）已批准其510(k)申请

cobas®

eplex

respiratory pathogen panel 3 (RP3). Designed for the automated

呼吸道病原体检测组合3（RP3）。专为自动化设计

cobas® eplex

system, this flexible syndromic test offers up to five customizable panel configurations, enabling labs and clinicians to rapidly and accurately identify the cause of respiratory infections to help ensure timely and effective patient care.

该系统提供多达五种可定制的检测组合配置，使实验室和临床医生能够快速准确地识别呼吸道感染的病因，从而确保及时有效的患者护理。

继续阅读

Roche receives FDA 510(k) clearance for new cobas® eplex respiratory pathogen panel 3.

罗氏公司获得美国FDA 510(k)许可，用于其新型cobas® eplex呼吸道病原体检测面板3。

During peak respiratory seasons, health systems face immense pressure to accurately differentiate viral and bacterial infections that often have overlapping symptoms. When clinicians have accurate and rapid respiratory results, they can reduce the number of tests and radiographs ordered, decrease unnecessary antibiotic use and decrease the length of time to discharge..

在呼吸道疾病高发季节，医疗系统面临着巨大压力，需要准确区分症状常常重叠的病毒性和细菌性感染。当临床医生能够获得准确且快速的呼吸道检测结果时，他们可以减少所申请的检查数量和影像学拍摄次数，降低不必要的抗生素使用，并缩短患者的住院时间。

'Timely and accurate respiratory testing in critical situations can guide life-saving interventions,' said Dan Malarek, President and CEO, Roche Diagnostics North America. 'The cobas® eplex RP3 panel gives laboratories the range of testing choices they need with quick turnaround times that can make a difference in patient care.'.

“在危急情况下，及时且准确的呼吸道检测可以指导挽救生命的干预措施。”罗氏诊断北美区总裁兼首席执行官 Dan Malarek 表示。“cobas® eplex RP3 检测面板为实验室提供了所需的多种检测选择，其快速的周转时间能够对患者护理产生积极影响。”

Diagnostic uncertainty creates challenges, particularly for high-risk populations – including the elderly, young children and the immunocompromised – who are at increased risk for severe complications.

诊断不确定性带来了挑战，尤其是对高风险人群——包括老年人、幼儿和免疫功能低下者——他们发生严重并发症的风险更高。

The

这

cobas® eplex

RP3 panel addresses these challenges by providing rapid, actionable insights that facilitate efficient patient management and antibiotic stewardship.

RP3 检测面板通过提供快速、可操作的见解，应对这些挑战，从而促进高效的患者管理和抗生素管理。

About the cobas

关于 cobas

eplex respiratory pathogen panel 3 (RP3)

eplex 呼吸道病原体检测 panel 3（RP3）

The

这

cobas® eplex

respiratory pathogen panel 3 (RP3) simultaneously detects up to 19 viral and bacterial targets, with broad strain inclusivity, from a single nasopharyngeal swab sample. Like the RP2 panel (EUA),* the RP3 panel detects common pathogens, such as influenza A virus, RSV and SARS-CoV-2, with the addition of .

呼吸道病原体检测 panel 3（RP3）可单次鼻咽拭子样本同时检测多达19种病毒和细菌靶标，具有广泛的菌株覆盖性。与RP2 panel（紧急使用授权，EUA）*类似，RP3 panel可检测常见病原体，如甲型流感病毒、呼吸道合胞病毒（RSV）和SARS-CoV-2，并新增了。

Bordetella pertussis

百日咳博德特氏菌

, to broaden targeting of bacterial pathogens that can cause severe illness in high-risk patients. The

，以扩大对可能导致高危患者严重疾病的细菌病原体的靶向范围。

cobas® eplex

RP3 panel also has updated assays for influenza virus and SARS-CoV-2 to improve coverage of current and recently circulating strains. It enables laboratories to tailor testing strategies with up to five distinct panel configurations, aligning with local disease prevalence and specific patient population needs..

RP3 面板还更新了流感病毒和 SARS-CoV-2 的检测项目，以提高对当前及近期流行毒株的覆盖范围。它使实验室能够通过多达五种不同的面板组合来定制检测策略，从而与当地疾病流行情况和特定患者群体的需求保持一致。

With an automated 'sample-to-answer' workflow process, the test requires less than one minute of hands-on preparation time and supports 24/7 availability. It also delivers highly accurate, qualitative results in less than two hours.

凭借自动化的“样本到结果”工作流程，该检测仅需不到一分钟的人工操作准备时间，并支持全天候24/7运行。它还能在不到两小时内提供高度准确的定性结果。

This FDA clearance further expands Roche's

此次美国食品药品监督管理局（FDA）的批准进一步扩大了罗氏的

respiratory portfolio

呼吸产品组合

, which includes a broad range of singleplex and multiplex assays for respiratory viral and bacterial infections, supporting patient testing needs across the continuum of care.

，其中包括用于呼吸道病毒和细菌感染的广泛单重和多重检测，支持贯穿整个护理过程的患者检测需求。

About Roche

关于罗氏

Roche (SIX: RO, ROP; OTCQX:

罗氏（SIX: RO, ROP；OTCQX:

RHHBY

) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

）是一家医疗保健公司，通过整合诊断、药物和数字解决方案领域的领先科技，在预防、遏制和治愈疾病方面拥有独特优势。

Roche was founded in Basel, Switzerland, in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems.

罗氏于1896年在瑞士巴塞尔成立，如今是全球150多个国家的数百万人变革性药物和诊断服务的领先供应商。它致力于应对给患者、家庭、社区和医疗系统带来最大压力的医疗保健挑战。

Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases, and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them..

罗氏在其诊断和制药业务领域，专注于肿瘤学、神经学、心血管与代谢疾病、眼科学、传染病以及免疫学等领域，旨在为患者、他们所爱的人以及照护他们的医疗专业人士带来切实而积极的改变。

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

美国的基因泰克（Genentech）是罗氏集团的全资子公司。罗氏是日本治疗性抗体市场的主要创新者中外制药（Chugai Pharmaceutical）的控股股东。

For more information, please visit

如需更多信息，请访问

www.roche.com

。

All trademarks used or mentioned in this release are protected by law.

本版本中使用或提及的所有商标均受法律保护。

cobas

eplex

RP2 has not been cleared or approved by the FDA. This test is authorized for use by qualified laboratories under an Emergency Use Authorization.

RP2 尚未获得美国食品药品监督管理局（FDA）的清除或批准。本检测已获紧急使用授权，仅限由具备资质的实验室使用。

References