Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the cobas® Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology. TAGS technology, developed by Roche scientists, uses multiplex polymerase chain reaction (PCR) testing, combined with colour, temperature and data processing, to identify as many as 15 pathogens in a single PCR test. Typically, PCR tests on a high throughput analyser are able to identify four results in a single test - TAGS technology makes it possible to increase this number to fifteen. This will enable syndromic panel testing on the high throughput molecular diagnostic analysers cobas® 5800, 6800 and 8800, which is especially important when a common group of symptoms can be related to more than one pathogen.

罗氏 (SIX: RO, ROG; OTCQX: RHHBY) 今天宣布推出 cobas® Respiratory flex 测试，这是首次使用罗氏新颖的专有 TAGS（温度激活信号生成）技术。罗氏科学家开发的 TAGS 技术使用多重聚合酶链反应 (PCR) 检测，结合颜色、温度和数据处理，可在一次 PCR 检测中识别多达 15 种病原体。通常，高通量分析仪上的 PCR 测试能够在一次测试中识别出四个结果 - TAGS 技术可以将这个数字增加到 15 个。这将使在高通量分子诊断分析仪 cobas® 5800、6800 和 8800 上进行综合征面板测试成为可能，这在常见症状组可能与多种病原体相关时尤为重要。

“Many respiratory illnesses share similar symptoms, making them difficult to diagnose. As respiratory outbreaks, combined with growing incidence of antibiotic resistance continue, getting an accurate and timely diagnosis is critical to providing the best care for patients and curbing transmission,” said Matt Sause, CEO of Roche Diagnostics. “Using TAGS technology, the cobas Respiratory flex test can help clinicians identify specific respiratory viruses sooner, helping to speed up diagnosis and get the right care to patients.”

“许多呼吸道疾病的症状相似，因此很难诊断。随着呼吸道疾病的爆发，以及抗生素耐药性发病率的不断上升，及时准确的诊断对于为患者提供最佳护理和遏制传播至关重要，”罗氏诊断首席执行官 Matt Sause 表示。“使用 TAGS 技术，cobas Respiratory flex 测试可以帮助临床医生更快地识别特定的呼吸道病毒，从而有助于加快诊断并为患者提供正确的护理。”

The cobas Respiratory flex test can detect up to 12 of the most common respiratory viruses, including influenza A, influenza B, Respiratory Syncytial Virus (RSV) and SARS-CoV-2, within a patient sample using a single PCR test. The test also allows clinicians to specify which pathogens to look for using pre-selected targets. With this, clinicians are able to factor in the test setting, season, locality and patient-specific factors. For example, a clinician might use a targeted test in the winter months to find out if a typically healthy adult patient has influenza or SARS-CoV-2 when those particular respiratory viruses are prevalent. Typically, when clinicians assess a certain group of targets first, diagnosis can be delayed if follow-up tests are needed. Through digital reflex, the cobas Respiratory flex test removes that delay by enabling the generation of additional results instantly or within seconds and without having to collect another sample or to run the existing sample again.

cobas Respiratory flex 测试可通过一次 PCR 测试检测出患者样本中多达 12 种最常见的呼吸道病毒，包括甲型流感、乙型流感、呼吸道合胞病毒 (RSV) 和 SARS-CoV-2。该测试还允许临床医生使用预先选择的目标来指定要寻找的病原体。这样，临床医生就可以考虑测试环境、季节、地点和患者特定因素。例如，当这些特定的呼吸道病毒流行时，临床医生可能会在冬季使用针对性测试来确定通常健康的成年患者是否患有流感或 SARS-CoV-2。通常，当临床医生首先评估某一组目标时，如果需要进行后续测试，诊断可能会延迟。通过数字反射，cobas Respiratory flex 测试可以消除这种延迟，因为它可以立即或在几秒钟内生成其他结果，而无需收集另一个样本或再次运行现有样本。

Delivering comprehensive results in a single PCR test, the cobas Respiratory flex test avoids the need for multiple test kits. This simplifies laboratory logistics, helping to optimise the use of resources and reduce pressure on labs. The test is now available in countries accepting CE-mark, and multiple countries around the world have initiated their local registrations. The U.S., 510(k) clearance from FDA will follow with submission planned for Q4. Additionally, the TAGS technology has potential across multiple types of pathogens and indications, offering the chance to revolutionise high throughput testing for infectious diseases in future.

cobas Respiratory flex 检测只需一次 PCR 检测即可提供全面结果，无需使用多个检测试剂盒。这简化了实验室物流，有助于优化资源利用并减轻实验室压力。该检测现已在接受 CE 标志的国家/地区推出，全球多个国家/地区已开始进行本地注册。FDA 将随后获得美国 510(k) 批准，并计划于第四季度提交申请。此外，TAGS 技术在多种病原体和适应症中都具有潜力，为未来革新传染病的高通量检测提供了机会。

TAGS (Temperature-Activated Generation of Signal) technology

TAGS（温度激活信号生成）技术

Roche’s temperature-activated generation of signal (TAGS) technology, is introduced to differentiate up to three targets per fluorescence channel, enabling the detection and differentiation of up to 15 diagnostic results per well - all out of a single test kit. Roche’s new TAGS technology overcomes the technical limitations of a typical 4-plex test result in previous solutions, using a novel, proprietary approach. Without having to upgrade hardware or software in existing cobas 5800, 6800 and 8800 systems, labs will immediately be able to deliver fast, accurate, high throughput flexible syndromic multiplex PCR testing to central laboratories.

罗氏的温度激活信号生成 (TAGS) 技术可区分每个荧光通道多达三个目标，从而能够检测和区分每个孔中多达 15 个诊断结果 - 所有这些都来自一个测试套件。罗氏的新型 TAGS 技术使用一种新颖的专有方法克服了以前解决方案中典型的 4 重测试结果的技术限制。无需升级现有 cobas 5800、6800 和 8800 系统中的硬件或软件，实验室将能够立即向中央实验室提供快速、准确、高通量的灵活综合多重 PCR 测试。

cobas Respiratory flex test

cobas 呼吸道弹性测试

The cobas Respiratory flex test runs on the cobas 5800, 6800 and 8800 systems. The cobas Respiratory flex test offers qualitative detection and differentiation of Influenza A & B, Respiratory Syncytial Virus (RSV), Adenovirus (AdV), human Metapneumovirus (hMPV), Enterovirus/Rhinovirus (EV/RV), Parainfluenza 1, 2, 3 & 4, Coronavirus (229E, OC43, NL63, HKU1), and SARS-CoV-2 in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.

cobas 呼吸道弹性测试可在 cobas 5800、6800 和 8800 系统上运行。cobas 呼吸道弹性测试可定性检测和区分具有呼吸道感染体征和症状并伴有临床和流行病学风险因素的患者的鼻咽拭子样本中的甲型和乙型流感病毒、呼吸道合胞病毒 (RSV)、腺病毒 (AdV)、人类亚肺病毒 (hMPV)、肠道病毒/鼻病毒 (EV/RV)、副流感病毒 1、2、3 和 4、冠状病毒 (229E、OC43、NL63、HKU1) 和 SARS-CoV-2。

Roche’s engagement in respiratory diagnostics

罗氏在呼吸道诊断领域的投入

The launch of the cobas Respiratory flex test further strengthens Roche's comprehensive portfolio in respiratory diagnostics, which also includes the newly rebranded cobas® eplex system, a world-class solution for multiplex and syndromic testing. This launch also follows recent news that the FDA had granted Emergency Use Authorization for Roche’s four-in-one cobas® liat test for SARS-CoV-2, Influenza A/B & RSV enabling rapid, multiplex PCR diagnostic tests to be undertaken in emergency departments, urgent care facilities and physician office labs. Roche remains committed to offering a wide range of diagnostics solutions both for large laboratories and smaller, near-patient settings.

cobas Respiratory flex 检测的推出进一步增强了罗氏在呼吸道诊断领域的综合产品组合，其中还包括新更名的 cobas® eplex 系统，这是一种世界一流的多重和综合检测解决方案。此次发布还遵循了最近的消息，即 FDA 已授予罗氏四合一 cobas® liat 检测的紧急使用授权，用于检测 SARS-CoV-2、甲型流感/乙型流感和呼吸道合胞病毒，可在急诊室、紧急护理机构和医生办公室实验室进行快速、多重 PCR 诊断测试。罗氏始终致力于为大型实验室和小型近患者环境提供广泛的诊断解决方案。