REDWOOD CITY, Calif.--(BUSINESS WIRE)--Karius®, Inc., a leader in genomic diagnostics for infectious diseases, announced today that the Karius Test® has been granted designation as a Breakthrough Device from The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA), for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia..

加利福尼亚州红木市——（商业新闻短讯）——传染病基因组诊断领域的领导者Karius®公司今天宣布，Karius Test®已被美国食品和药物管理局（FDA）设备与放射健康中心（CDRH）指定为突破性设备，用于诊断和管理疑似肺部感染（包括下呼吸道感染和肺炎）的免疫功能低下患者。。

“The Karius Test is commercially available nationwide as a laboratory developed test. We are seeking FDA marketing authorization of the Karius Test for lung infections in immunocompromised patients because improved diagnostic tests are urgently needed for these patients,” stated Brad Perkins, M.D., Chief Medical Officer of Karius.

Karius首席医学官Brad Perkins医学博士表示：“Karius测试作为实验室开发的测试在全国范围内可商购。我们正在寻求FDA对免疫功能低下患者肺部感染的Karius测试的上市授权，因为这些患者迫切需要改进诊断测试。”。

“As noted in the American Thoracic Society (ATS) Workshop Report for Immunocompromised Host Pneumonia: Definitions and Diagnostic Criteria,1 lung infections have high morbidity and mortality in immunocompromised patients, which is why advances in technologies like metagenomic sequencing used for the Karius Test are vital in improving the diagnosis and treatment of these patients.”.

“正如美国胸科学会（ATS）关于免疫功能低下宿主肺炎的研讨会报告：定义和诊断标准所指出的那样，1肺部感染在免疫功能低下患者中具有高发病率和死亡率，这就是为什么用于Karius测试的宏基因组测序等技术的进步对于改善这些患者的诊断和治疗至关重要。”。

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these innovative medical devices..

突破设备计划是针对某些医疗设备和以设备为主导的组合产品的自愿计划，这些产品可以更有效地治疗或诊断危及生命或不可逆转的衰弱疾病或病症。该计划旨在加快这些创新医疗设备的开发和审查。。

Clinical data that support the use of the Karius Test in pneumonia for immunocompromised patients includes the results of the PICKUP study, where results showed that the Karius Test increased the relative yield for detection of a probable cause for pneumonia by 40%.2 Additionally, the Karius Test identified clinically relevant non-pneumonia infections in 39% of subjects.2 These additional data highlight the ATS Workshop Report observation that 'the existing clinical definition of pneumonia is syndromic and lacks specificity,' 1 and support the value of approaches that are agnostic to both the pathogen and the site of infection like the Karius Test..

支持在免疫功能低下患者的肺炎中使用卡里乌斯试验的临床数据包括皮卡研究的结果，结果显示卡里乌斯试验使检测肺炎可能原因的相对产率提高了40%。2此外，卡里乌斯试验在39%的受试者中发现了临床相关的非肺炎感染。2这些额外数据突出了ATS研讨会报告的观察结果，即“肺炎的现有临床定义是综合征性的，缺乏特异性”，1并支持了对病原体和感染部位不可知的方法的价值，如卡里乌斯试验。。

“Recent data from several trials indicate that the Karius Test offers a speedy, accurate, and sensitive diagnosis of infectious causes of pneumonia and related infections in immunocompromised patients. As such, it represents a major advance in the care of patients with hematologic cancers and those undergoing stem cell transplantation,” said Norman E.

诺曼·E说：“几项试验的最新数据表明，卡里乌斯试验可以快速、准确、灵敏地诊断免疫功能低下患者肺炎和相关感染的感染原因。因此，它代表了血液癌症患者和干细胞移植患者护理方面的重大进步。”。

Sharpless, MD; former Director of the National Cancer Institute and Acting Commissioner of the Food and Drug Administration, and member of the Karius board..

马里兰州夏普利斯；美国国家癌症研究所前所长、食品和药物管理局代理专员、Karius董事会成员。。

New data from the PICKUP study on the cost-effectiveness of the Karius Test will be presented at the American Thoracic Society Annual Meeting 2024 International Conference.

关于卡里乌斯试验成本效益的皮卡研究的新数据将在2024年美国胸科学会年会国际会议上公布。

To learn more about Karius Test diagnostic applications for infectious disease, including pneumonia, endocarditis, invasive fungal disease, febrile neutropenia, and fever of unknown origin, visit us at kariusdx.com.

要了解更多有关Karius测试在传染病诊断中的应用，包括肺炎，心内膜炎，侵袭性真菌病，发热性中性粒细胞减少症和不明原因发热，请访问kariusdx.com。

About Karius

关于Karius

Karius Inc., a leader in genomic diagnostics for infectious diseases, harnesses metagenomics, next-generation sequencing, and artificial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis.

Karius Inc.是传染病基因组诊断领域的领导者，它利用宏基因组学、下一代测序和人工智能（AI）来帮助提高病原体诊断的准确性和速度。

Karius Test® is a Laboratory Developed Test (LDT) performed in a CLIA-certified and CAP-accredited laboratory to perform high-complexity clinical laboratory testing. The Karius Test®, used in over 400 healthcare institutions across the United States, identifies more than 1,000 pathogens, including viruses, bacteria, fungi, and parasites from a single blood draw typically within a day of sample receipt.

Karius Test®是在CLIA认证和CAP认证的实验室中进行的实验室开发测试（LDT），用于执行高度复杂的临床实验室测试。Karius Test®用于美国400多家医疗机构，通常在收到样本后的一天内，从一次抽血中识别出1000多种病原体，包括病毒，细菌，真菌和寄生虫。

A landmark study in the Journal of Clinical Microbiology found that the Karius Test detected 701 unique microbial taxa across a cohort of 15,000 patients, making it the largest study of its kind, demonstrating the capability of the Karius Test in pathogen identification.

《临床微生物学杂志》（Journal of Clinical Microbiology）上一项具有里程碑意义的研究发现，Karius测试在15000名患者队列中检测到701种独特的微生物类群，使其成为同类研究中规模最大的研究，证明了Karius测试在病原体鉴定中的能力。