/PRNewswire/ -- Roche today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas Respiratory 4-flex. This is the first FDA-cleared assay utilizing Roche's innovative TAGS (Temperature-Activated Generation of Signal) technology, designed to streamline respiratory testing, and to ensure timely and accurate diagnoses for patients.

罗氏今天宣布获得美国食品和药物管理局 （FDA） 510（k） 批准科巴斯® 呼吸 4-flex。这是第一个获得 FDA 批准的检测方法，采用罗氏创新的 TAGS（温度激活信号生成）技术，旨在简化呼吸检测，并确保患者及时准确地诊断。

The cobas® Respiratory 4-flex is used with the cobas® 5800, 6800 and 8800 systems.

cobas® Respiratory 4-flex 与 cobas® 5800、6800 和 8800 系统一起使用。

The new test provides accurate PCR results for the four most common respiratory viruses: SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV). This enables physicians to promptly initiate targeted treatment plans to improve patient care. The test consolidates these four key targets into a single, efficient assay, simplifying laboratory workflows and optimizing resource use.

新的测试为四种最常见的呼吸道病毒：新冠病毒、甲型流感、乙型流感和呼吸道合胞病毒（RSV）提供准确的PCR结果。这使医生能够迅速启动有针对性的治疗方案，以改善患者护理。该测试将这四个关键目标整合到一个高效的检测中，简化了实验室工作流程并优化了资源利用。

It integrates seamlessly with Roche's .

它与罗氏的系统无缝集成。

5800, 6800 and 8800 molecular lab instruments.

5800、6800和8800分子实验室仪器。

Respiratory 4-flex assay offers a significant technological advancement that empowers labs to address evolving respiratory testing demands now and in the future,' said

呼吸系统4-flex检测提供了一项重要的技术进步，使实验室能够应对当前和未来的呼吸检测需求。

Brad Moore

布拉德·摩尔

, President and CEO of Roche Diagnostics North America. 'The expanded testing capabilities, enabled by TAGS technology, will allow labs to deliver reliable and relevant patient testing, while also optimizing healthcare resources.'

罗氏诊断北美公司总裁兼首席执行官表示：“通过TAGS技术支持的扩展检测能力，将使实验室能够提供可靠且相关的患者检测，同时优化医疗资源。”

With its customizable testing menu,

凭借其可定制的测试菜单，

Respiratory 4-flex enables laboratories to tailor testing to physician orders and patient needs, reducing the need for repeat healthcare visits and tests. The test includes a 'digital reflex'* option, which allows for additional testing from the same sample. For example, if the physician requests influenza A and B and the results are negative, a digital reflex can request results for SARS-CoV-2 or RSV, focusing on relevant tests for the patient.

呼吸系统4-flex使实验室能够根据医生的指令和患者的需求定制检测，减少重复就诊和检测的需要。该测试包含“数字反射”*选项，可对同一样本进行额外检测。例如，如果医生要求检测甲型和乙型流感且结果为阴性，则可以通过数字反射请求检测SARS-CoV-2或RSV，专注于针对患者的相关检测。

While raw data for all targets is generated and available, only requested results are analyzed and reported, ensuring targeted and efficient testing..

虽然所有目标的原始数据均已生成并可用，但仅对请求的结果进行分析和报告，从而确保有针对性且高效的测试。

'Our goal for the Respiratory 4-flex is to allow labs to customize testing based on clinical needs, patient symptoms, which are often similar, and to better support a constantly shifting respiratory landscape,' said Denise Heaney, Ph.D., Chief Medical Partner, Molecular Solutions and Infectious Disease at Roche Diagnostics.

“我们对呼吸道4-flex的目标是让实验室能够根据临床需求和患者症状（通常相似）来定制检测，并更好地支持不断变化的呼吸道环境，”罗氏诊断分子解决方案和传染病首席医学合作伙伴丹尼斯·希尼博士表示。

'TAGS technology allows for the detection of more targets on a high-throughput platform, which supports diagnostic stewardship while reaching a broader patient population.'.

“TAGS技术可以在高通量平台上检测更多目标，这有助于诊断管理，同时覆盖更广泛的患者群体。”

This launch further expands Roche's

此次发布进一步扩大了罗氏的

respiratory portfolio

呼吸系统产品组合

, 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.

，其中包括一系列针对呼吸道病毒和细菌感染的单重和多重检测方法，支持患者在整个护理过程中的检测需求。

TAGS (Temperature-Activated Generation of Signal) technology

温度激活信号生成（TAGS）技术

Leveraging Roche's innovative TAGS technology, cobas Respiratory 4-flex lays the groundwork for future expanded testing capabilities. Developed by Roche scientists,

利用罗氏创新的TAGS技术，cobas Respiratory 4-flex为未来扩展检测能力奠定了基础。该产品由罗氏科学家开发，

TAGS technology

技术标签

uses multiplex polymerase chain reaction (PCR) testing, combined with color, temperature and data processing, to enable the detection and differentiation of multiple targets within a single optical channel.

使用多重聚合酶链反应 (PCR) 检测，结合颜色、温度和数据处理，以实现单个光学通道内多个目标的检测和区分。

About cobas Respiratory 4-flex

关于cobas呼吸道4-flex

Respiratory 4-flex runs on the

呼吸4-flex运行在

cobas

罗氏诊断

5800, 6800 and 8800 systems. The test offers qualitative detection and differentiation of SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV) in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection, along with clinical and epidemiological risk factors..

5800、6800和8800系统。该测试可对新冠病毒、甲型流感、乙型流感以及呼吸道合胞病毒（RSV）进行定性检测和区分，适用于有呼吸道感染症状和体征的患者鼻咽拭子样本，并结合临床和流行病学风险因素进行分析。

About Roche

关于罗氏

Founded in 1896 in

成立于1896年

Basel, Switzerland

瑞士巴塞尔

, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world.

作为最早生产品牌药品的工业制造商之一，罗氏已经成长为全球最大的生物技术公司，也是体外诊断领域的全球领导者。该公司追求科学卓越，致力于发现和开发药物及诊断工具，以改善和拯救世界各地人们的生命。

We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice..

我们是个性化医疗的先驱，希望进一步改变医疗服务的提供方式，以产生更大的影响。为了给每个人提供最佳的护理，我们与许多利益相关者合作，将我们在诊断和制药领域的优势与临床实践中的数据洞察相结合。

For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045..

125 多年来，可持续发展一直是罗氏业务的重要组成部分。作为一家以科学为驱动的公司，我们对社会的最大贡献是开发创新药物和诊断技术，帮助人们过上更健康的生活。罗氏致力于科学基础目标倡议和可持续市场倡议，到 2045 年实现净零排放。