Selux Diagnostics宣布Selux PBC分离器和Selux AST系统获得FDA 510(k)批准，可直接从阳性血培养液中进行快速抗生素敏感性测试-动脉网

The Selux PBC Separator With Selux AST System Receives FDA 510(k) Clearance for Rapid Antibiotic Susceptibility Testing Direct From Positive Blood Culture

BioSpace 等信源发布 2024-02-26 16:03

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The Selux PBC Separator, part of the Next Generation Phenotyping (NGP) System, makes this the only FDA cleared, single-platform technology capable of delivering rapid AST results for both positive blood culture and isolated colonies.

Selux PBC分离器是下一代表型（NGP）系统的一部分，使其成为唯一一种FDA批准的单平台技术，能够为阳性血培养和分离菌落提供快速AST结果。

BOSTON, MA / ACCESSWIRE / February 26, 2024 / Selux Diagnostics, a biotech startup in Boston whose mission is to combat superbug infections and preserve the lifesaving power of antibiotics for future generations, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary Positive Blood Culture (PBC) Separator.

波士顿，马萨诸塞州/ACCESSWIRE/2024年2月26日/Selux Diagnostics，一家位于波士顿的生物技术初创公司，其使命是对抗超级细菌感染并为子孙后代保存抗生素的救生能力，宣布其专有阳性血培养（PBC）分离器已获得美国食品和药物管理局（FDA）510（k）的许可。

The addition of positive blood culture sample type expands the Selux NGP System, a rapid AST platform that can provide targeted therapeutic results days faster than the current standard of care..

阳性血培养样本类型的增加扩展了Selux NGP系统，这是一种快速AST平台，可以比当前的护理标准更快地提供靶向治疗结果。。

Selux PBC Separator

Selux PBC分离器

The Selux PBC Separator with Selux AST System receives FDA 510(k) Clearance

带有Selux AST系统的Selux PBC分离器获得FDA 510（k）许可

The Selux PBC Separator allows labs to test directly from positive blood culture without the need to subculture by automatically preparing the sample for susceptibility testing. This latest FDA clearance determines a bacteria's susceptibility to 17 specific antibiotic agents on the Selux Gram Negative Panel..

Selux PBC分离器允许实验室直接从阳性血培养物中进行检测，而无需通过自动制备样品进行药敏试验进行传代培养。这项最新的FDA许可证确定了细菌对Selux革兰氏阴性面板上17种特定抗生素的敏感性。。

The Selux PBC Separator has already garnered FDA Breakthrough Designation, acknowledging its potential to address the critical need for performing AST directly from positive blood culture and other sterile body fluids. The FDA's Breakthrough Devices Program aims to provide timely access to medical devices that improve the treatment or diagnosis of life-threatening or debilitating human diseases or conditions..

Selux PBC分离器已经获得FDA突破性的指定，承认其有潜力解决直接从阳性血培养和其他无菌体液中进行AST的关键需求。FDA的突破性设备计划旨在及时提供医疗设备，以改善威胁生命或使人衰弱的人类疾病或病症的治疗或诊断。。

Steve Lufkin, CEO of Selux Diagnostics, commented, 'This third 510(k) clearance for Selux marks a significant advancement in infectious disease care. The Selux NGP System is the only AST platform able to deliver rapid AST results direct from positive blood culture and isolated colonies. We extend our gratitude to our employees, partners, and advisors whose contributions were instrumental in achieving this breakthrough designated accomplishment.'.

Selux Diagnostics首席执行官史蒂夫·卢夫金（SteveLufkin）评论道：“Selux第三次510（k）许可标志着传染病护理的重大进步。Selux NGP系统是唯一能够直接从阳性血培养和分离菌落中提供快速AST结果的AST平台。我们感谢我们的员工、合作伙伴和顾问，他们的贡献有助于实现这一突破性的指定成就。”。

James S. Lewis II, PharmD, FIDSA, co-director of antibiotic stewardship at Oregon Health and Science University and chair of the CLSI Antimicrobial Susceptibility Testing Subcommittee, remarked, 'The infectious disease community has eagerly awaited innovative technology to bolster our fight against difficult to treat infections.

俄勒冈健康与科学大学（Oregon Health and Science University）抗生素管理联合主任兼CLSI抗菌药物敏感性测试小组委员会主席詹姆斯·刘易斯（James S.Lewis II）表示，“传染病界迫切期待创新技术来支持我们对抗难以治疗的感染的斗争。

This clearance, coupled with the Selux NGP System, marks a significant leap forward.'.

这一许可，再加上Selux NGP系统，标志着一个重大的飞跃。”。

For more information on the Selux NGP System, visit www.seluxdx.com.

有关Selux NGP系统的更多信息，请访问www.seluxdx.com。

Acknowledgment

致谢

This platform has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); and Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201800013C..

该平台已获得美国卫生与公众服务部（HHS）的全部或部分联邦资金的支持；战略准备和应对管理局（ASPR）；和生物医学高级研究与发展局（BARDA），合同号为HHSO100201800013C。。

About Selux Diagnostics

关于Selux诊断

Selux Diagnostics is transforming patient care by accelerating the selection of personalized antimicrobial therapy for all infectious disease patients. This advance will save lives, shorten hospital stays, and combat the growing antibiotic resistance epidemic by decreasing the overuse of broad-spectrum agents.

Selux Diagnostics正在通过加速为所有传染病患者选择个性化抗菌治疗来改变患者护理。这一进步将挽救生命，缩短住院时间，并通过减少广谱药物的过度使用来对抗日益增长的抗生素耐药性流行病。

Learn more at www.seluxdx.com..

The Selux Next Generation Phenotyping (NGP) System includes:

Selux下一代表型（NGP）系统包括：

Positive Blood Culture (PBC) Separator

阳性血培养（PBC）分离器

Selux Inoculator

Selux接种器

Selux Analyzer

Selux分析仪

Selux Gram Negative and Gram Positive Panels

Selux革兰氏阴性和革兰氏阳性面板