罗氏公司获得FDA批准的病毒载量测试，COBAS八千八分之六千八

StephenW

Media Release

Basel, 19 October 2015
Roche receives FDA approval for viral load tests and cobas 6800/8800 Systems “ Next Generation Viral Load Tests: HBV & HCV….under FDA review for HIV-1 and cytomegalovirus (CMV)"

cobas 6800/8800 Systems offer fastest time to results and highest throughput of any molecular platform, helping to improve disease management and patient care

http://www.roche.com/media/store/releases/med-cor-2015-10-19.htm

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for the cobas® HBV and cobas® HCV viral load tests, the first assays approved by the United States Food and Drug Administration (FDA) for use on the cobas® 6800 and cobas® 8800 Systems. The fully automated systems offer the fastest time to results, the highest throughput and the longest walk-away time available among automated molecular platforms, providing laboratories both improved operating efficiency and flexibility to adapt to changing testing needs. The new tests are the next generation of Roche’s viral load tests, which clinicians use to manage the treatment of patients chronically infected with hepatitis B or hepatitis C virus.

“These new systems will provide laboratories with solutions for routine molecular testing that offer excellent performance, unmatched flexibility and absolute automation,” said Roland Diggelmann, COO, Roche Diagnostics. “The cobas HBV and cobas HCV tests set new industry standards for viral load assays for the highly evolving hepatitis treatment regimens.”

In addition to the assays approved today, Roche currently has viral load tests under FDA review for HIV-1 and cytomegalovirus (CMV)*, which, when approved, will complete a comprehensive portfolio of viral load monitoring for the cobas 6800/8800 systems. Further menu expansion plans include qualitative tests for donor screening, women’s health and microbiology.
About the cobas 6800/8800 systems

The cobas 6800 and cobas 8800 systems are fully integrated, automated solutions that introduce a new standard for routine molecular testing in the areas of viral load monitoring, donor screening, women’s health and microbiology. Based on Nobel prize-winning PCR technology, the systems are designed to deliver full automation, increased throughput and faster turnaround time, providing users with greater flexibility to increase overall workflow efficiencies.

The systems provide up to 96 results in less than 3.5 hours and a total of 384 results for the cobas 6800 System and 960 results for the cobas 8800 System in an eight-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800) and four hours (cobas 8800) of walk-away time with minimal user interaction.

For more information about the systems, please visit www.cobas68008800.com or http://molecular.roche.com.
About the cobas HBV and HCV viral load tests for use on the cobas 6800/8800 Systems

The two new assays for viral load monitoring can run simultaneously on the cobas 6800/8800 systems, streamlining workflow while increasing flexibility for patient sample management.

cobas HBV is a real-time PCR test designed to offer an expanded linear range coupled with broad coverage of all known HBV genotypes (A-H), including pre-core mutations with improved sensitivity.

cobas HCV employs Roche’s unique dual-probe approach to provide an extra layer of protection against mutations that can occur in the viral genome. It is designed to accurately detect and quantify HCV ribonucleic acid (RNA) of genotypes 1-6 with state-of-the-art sensitivity and is the first assay approved in the United States that can be used both to confirm active HCV infection and to assess a patient’s response to antiviral therapy. cobas HCV can confirm active HCV infection and provide the baseline viral load at the same time.

StephenW

媒体发布

巴塞尔，2015年10月19日
罗氏公司获得FDA批准的病毒载量测试，COBAS八千八分之六千八系统“下一代病毒载量测试：HBV与HCV ... .under FDA审​​查HIV-1和巨细胞病毒（CMV）”

COBAS八千八百分之六千八百系统提供最快的时间内效果和吞吐量的任何分子平台最高，帮助改善疾病管理和患者护理

http://www.roche.com/media/store/releases/med-cor-2015-10-19.htm

罗氏（SIX：RO，ROG; OTCQX：RHHBY）今天宣布，该公司已经获得FDA批准用于cobas®HBV和HCVcobas®病毒载量检测，使用经美国食品和药物管理局（FDA）的第一个试验在cobas®6800和cobas®8800系统。全自动化的系统提供了最快的时间结果，最高的吞吐量和最长的步行路程的时间内之间的自动化分子平台，提供实验室既提高了工作效率和灵活性，以适应不断变化的测试需求。新的测试是下一代罗氏的病毒载量测试，其临床使用管理的慢性感染乙肝或丙肝病毒的患者的治疗。

“这些新系统将提供实验室与提供卓越的性能，无与伦比的灵活性和绝对自动化常规的分子测试解决方案，”罗兰Diggelmann，COO，罗氏诊断说。 “在COBAS HBV和HCV的cobas测试行业设立了新标准，病毒载量检测的高度进化型肝炎的治疗方案。”

除了今天批准了试验，罗氏目前在FDA审评病毒载量检测为HIV-1和巨细胞病毒（CMV）*，其中，批准后，将完成对病毒载量监测一个全面的产品组合为COBAS八千八分之六千八百系统。而且菜单的扩张计划包括定性试验为献血者筛查，妇女的健康和微生物。
关于COBAS八千八百分之六千八百系统

在COBAS 6800和COBAS 8800系统完全集成，自动化的解决方案，介绍了在病毒载量监测，献血者筛查，妇女的健康和微生物学领域的常规分子检测的新标准。根据诺贝尔奖获奖PCR技术，该系统旨在提供完整的自动化，提高了吞吐量和更快的周转时间，为用户提供更大的灵活性，以提高整体工作流程效率。

该系统提供高达96的结果，在不到3.5小时，共384的结果为的cobas 6800系统和960的结果为的cobas 8800系统在八小时轮班。双方有可能使实验室进行最多三次检测，在相同的运行，无需预先分拣。该系统还支持最多八个小时（的cobas 6800），四个小时的步行路程时间和最少的用户交互（的cobas 8800）。

有关系统的更多信息，请访问www.cobas68008800.com或http://molecular.roche.com。
关于COBAS HBV和HCV病毒载量测试使用的COBAS八千八分之六千八系统

对病毒载量监测这两个新的分析方法可以在COBAS八千八分之六千八百系统同时运行，简化工作流程，同时提高灵活性病人样品管理。

COBAS HBV是一个实时PCR试验的设计提供加上所有已知HBV基因型（AH），包括前核心突变具有改进灵敏度的广泛覆盖的膨胀的线性范围。

COBAS HCV采用罗氏公司独特的双探头的方法来对可能出现的病毒基因组变异提供了额外的保护层。它的目的是精确地检测和量化基因型1-6与国家的最先进的敏感性的HCV核糖核酸（RNA），并且是批准在美国的第一测定，可用于既确认活动性HCV感染和评估患者的反应的抗病毒治疗。的cobas HCV可以确认活性HCV感染和提供基线病毒载量在同一时间。