Roche receives first FDA clearance for urine sample type for BK virus quantitative test to aid in the improvement of care for transplant patients


2021-02-12 09:31:38 BioSpace


Roche today announced the U.S. Food and Drug Administration 510K clearance of stabilised urine samples to be used with the cobas® BKV Test on the cobas® 6800/8800 Systems. This test, previously designated as a Breakthrough Device by the FDA and cleared for use with ethylenediaminetetraacetic acid plasma samples to aid in the management of BK virus in transplant patients, now also delivers enhanced diagnosis of disease via non-invasive, easily collected, prepared and stored urine samples. BKV can cause severe complications in immunocompromised transplant patients. Higher BKV DNA levels can often be present in urine prior to plasma, serving as an early predictor of an impending infection. A urine sample stabilised in cobas® PCR Media allows the integrity of urine results to be maintained, making storage and transportation simpler without the need for sample refrigeration. "Transplant patients face a number of significant challenges, including complications that can arise from viruses like BKV," said Ann Costello, Head Roche Diagnostic Solutions. "With the FDA clearance of this non-invasive and easily collectable sample type, we now offer choices for clinicians using a standardised, automated solution to routinely monitor and manage infection risks. Together with our viral load tests for Cytomegalovirus and Epstein-Barr virus, we are committed to bringing better care to transplant patients." The cobas BKV Test runs on the widely available, high-throughput cobas 6800/8800 Systems. It is also approved for use in CE markets with EDTA plasma and urine stabilised in cobas PCR Media as sample types. About the cobas BKV Test The cobas BKV Test is a real-time polymerase chain reaction (PCR) test with dual-target technology that provides quantitative accuracy and guards against the risk of sequence variations that may be present in the BK virus. The cobas BKV Test has robust coverage with a limit of detection of 21.5 IU/mL and an expanded linear range from 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma. Urine stabilised in cobas PCR Media has a limit of detection of 12.2 IU/mL and a linear range from 200 IU/mL to 1E+08 IU/mL. The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The test supports the goal of result standardisation across institutions by providing reproducible, high-quality results for clinical decision-making. The fully automated cobas BKV, cobas® CMV and cobas® EBV Tests can run on the cobas 6800/8800 Systems simultaneously, providing absolute automation with proven performance and flexibility, leading to time savings and increased efficiency. About BK polyomavirus BK polyomavirus (BKV) is a member of the polyomavirus family that can cause transplant-associated complications including nephropathy in kidney transplantation and hemorrhagic cystitis in hematopoietic stem cell transplantation. Infection can occur early in life, often with no symptoms. After primary infection, the virus can remain inactive throughout life, only to possibly reactivate in immunocompromised individuals, such as patients who receive solid-organ transplants. For kidney transplant patients, BKV infection is considered the most common viral complication, causing polyomavirus nephropathy (PVN) in up to 10 percent of kidney transplant recipients, and about 50 percent of PVN-affected patients will experience transplant graft failure.2  BKV is also associated with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.3 About the cobas 6800/8800 Systems When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7 — cobas 6800/8800 Systems are designed to ensure a lab's long-term sustainability and success … now, more than ever. Learn more now: About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. References [1] Jha V. Post-transplant infections: An ounce of prevention. Indian J Nephrol. 2010;20(4):171-178. [2] Jamboti, J. S. (2016) BK virus nephropathy in renal transplant recipients. Nephrology, 21: 647– 654. doi: 10.1111/nep.12728.   [3] Hirsch HH, Randhawa PS; AST Infectious Diseases Community of Practice. BK polyomavirus in solid organ transplantation-Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13528. doi:10.1111/ctr.13528 Media Contact: Elizabeth Baxter Roche Molecular Solutions Media Relations 925.523.8812 Mike Weist US Media Relations Roche Diagnostics Corporation 317.371.0035 multimedia:
罗氏公司今天宣布,美国食品和药物管理局对稳定尿样的510K清除率将用于®科巴斯6800/8800系统上的科巴斯®BKV测试。这项试验先前被FDA指定为突破性的设备,并获准与乙二胺四乙酸血浆样本一起使用,以帮助在移植患者中管理BK病毒,现在还通过非侵入性的、易于收集、准备和储存的尿样提供了疾病的增强诊断。 BKV可引起免疫功能低下移植患者的严重并发症。较高的BKV DNA水平常先于血浆出现在尿液中,作为即将发生感染的早期预测指标。在COBAS®PCR培养基中稳定的尿液样本允许保持尿液结果的完整性,使得储存和运输更简单,而不需要样品冷藏。 罗氏诊断解决方案公司负责人Ann Costello说:“移植病人面临许多重大挑战,包括BKV等病毒可能引起的并发症。”“随着FDA对这种非侵入性和易于收集的样本类型的清除,我们现在为临床医生提供了使用标准化、自动化解决方案来常规监测和管理感染风险的选择。连同我们的巨细胞病毒和爱泼斯坦-巴尔病毒的病毒载量测试,我们致力于为移植患者带来更好的护理。” cobas BKV测试在广泛可用的高吞吐量cobas 6800/8800系统上运行。它也被批准用于CE市场,以EDTA血浆和尿液在cobas PCR培养基中稳定为样本类型。 关于cobas BKV试验 cobas BKV检测是一种具有双靶技术的实时聚合酶链反应(PCR)检测,提供定量准确性,并防范BK病毒可能存在的序列变异风险。cobas BKV法在EDTA血浆中的检出限为21.5IU/ml,线性范围从21.5IU/ml扩展到1E+08IU/ml。尿在cobas PCR培养基中稳定,检出限为12.2IU/ml,线性范围为200~1E+08IU/ml。 该测试为实验室开发的测试(LDTs)或分析物特异性试剂(ASR)组合提供了另一种选择,潜在地将测试中的变异性和复杂性最小化,减少工作量并减轻实验室的风险。该测试通过为临床决策提供可重复的、高质量的结果来支持跨机构的结果标准化的目标。 完全自动化的cobas BKV、cobas®CMV和cobas®EBV测试可以在cobas 6800/8800系统上同时运行,提供经过验证的性能和灵活性的绝对自动化,从而节省时间和提高效率。 关于BK多瘤病毒 BK多瘤病毒(BKV)是多瘤病毒家族的一员,可引起移植相关并发症,包括肾移植时的肾病和造血干细胞移植时的出血性膀胱炎。感染可发生在生命早期,往往没有症状。在初次感染后,病毒会在一生中保持不活跃状态,只有在免疫功能低下的个体,如接受实体器官移植的患者中才可能重新活跃。对于肾移植患者来说,BKV感染被认为是最常见的病毒并发症,导致多瘤病毒肾病(PVN)的患者高达10%,约50%的PVN感染患者将经历移植失败。2 BKV还与异基因造血干细胞移植后出血性膀胱炎相关。3 关于cobas 6800/8800系统 当每一刻都很重要时,全自动化的cobas 6800/8800系统提供了自动化分子平台中最快的时间、最高的吞吐量和最长的离开时间。cobas 6800/8800系统具有经过验证的性能、绝对的自动化和无与伦比的灵活性,提供无与伦比的24/7吞吐量,旨在确保实验室的长期可持续性和成功……现在,比以往任何时候都更好。现在了解更多信息 关于罗氏 罗氏是全球制药和诊断领域的先驱,专注于推进科学以改善人们的生活。在同一屋檐下的制药和诊断的联合优势使罗氏成为个性化医疗的领导者--这是一种旨在以最佳方式为每一位患者提供正确治疗的战略。 罗氏是世界上最大的生物技术公司,在肿瘤学、免疫学、传染病、眼科和中枢神经系统疾病方面拥有真正差异化的药品。罗氏在体外诊断和基于组织的癌症诊断方面也是世界领先者,在糖尿病管理方面也是领跑者。 成立于1896年的罗氏公司继续寻求更好的预防、诊断和治疗疾病的方法,为社会做出可持续的贡献。该公司还致力于通过与所有相关利益攸关方合作,改善患者获得医疗创新的机会。罗氏公司开发的30多种药物被列入世界卫生组织基本药物示范目录,其中包括救命抗生素、抗疟药和癌症药物。此外,罗氏公司连续第十二年被道琼斯可持续发展指数(DJSI)评为制药行业最具可持续发展能力的公司之一。 罗氏集团总部位于瑞士巴塞尔,业务遍及100多个国家,2020年全球员工超过10万人。2020年,罗氏研发投入122亿瑞士法郎,公布销售额583亿瑞士法郎。美国基因泰克公司是罗氏集团的全资成员。罗氏是日本中外制药的大股东。欲了解更多信息,请访问。 本新闻稿中使用或提及的所有商标均受法律保护。 参考文献 [1]Jha诉移植后感染:一盎司的预防。印度J.尼弗洛尔。2010年;20(4):171-178。 [2]Jamboti,J.S.(2016年)肾移植受者中的BK病毒肾病。肾脏病,21:647-654。DOI:10.1111/NEP.12728。 [3]Hirsch HH,Randhawa PS;传染病实践社区。固体器官移植中的BK多瘤病毒-美国移植学会传染病实践社区指南。临床移植。2019年;33(9):E13528。DOI:10.1111/Ctr.13528 媒体联系人: 伊丽莎白·巴克斯特 罗氏分子溶液介质关系 电子邮件 925.523.8812 迈克·韦斯特 美国媒体关系 罗氏诊断公司 317.371.0035 多媒体: