登录

Akoya Biosciences和Shanghai KR Pharmtech宣布中国监管机构批准KR-HT5在中国上市,以支持下一代病理学临床工作流程

Akoya Biosciences and Shanghai KR Pharmtech Announce Chinese Regulatory Agency Premarket Approval for KR-HT5 in China to Support Next Generation Pathology Clinical Workflows

GlobeNewswire | 2024-05-02 | 翻译由动脉网AI生成,点击反馈

可切换为仅中文


MARLBOROUGH, Mass. and SHANGHAI, China, May 02, 2024 (GLOBE NEWSWIRE) -- Akoya Biosciences, Inc. (Nasdaq: AKYA), The Spatial Biology Company®, and Shanghai KR Pharmtech, a leading company providing molecular diagnostic solutions in China, have jointly announced that KR-HT5, which Akoya Biosciences co-developed with Shanghai KR Pharmtech utilizing the PhenoImager HT technology as its foundation, has received premarket approval from China's National Medical Products Administration (NMPA) to support next generation pathology clinical workflows.

马萨诸塞州马尔堡和中国上海,2024年5月2日(环球通讯社)--空间生物公司®Akoya Biosciences,Inc.(Nasdaq:AKYA)和在中国提供分子诊断解决方案的领先公司上海KR Pharmtech联合宣布,Akoya Biosciences与上海KR Pharmtech利用PhenoImager HT技术共同开发的KR-HT5已获得中国国家医药产品管理局(NMPA)的上市前批准,以支持下一代病理学临床工作流程。

The NMPA serves as the national regulatory body in China, overseeing the safety, quality, and efficacy of medical products, encompassing pharmaceuticals and medical devices. Obtaining NMPA approval indicates that the regulatory authority has examined and sanctioned the product for sale or utilization in the Chinese clinical market.

NMPA是中国的国家监管机构,负责监督医疗产品(包括药品和医疗器械)的安全性、质量和功效。获得NMPA批准表明监管机构已审查并批准该产品在中国临床市场上销售或使用。

The KR-HT5 is a product jointly developed by Akoya Biosciences and Shanghai KR Pharmtech for Chinese clinical needs. Built on the PhenoImager HT core technologies, specifically Akoya's Multispectral Imaging (MSI) and spectral unmixing technologies, KR-HT5 will provide clinicians with a high-throughput platform to enable analysis for multiplex biomarker workflows.

KR-HT5是由Akoya Biosciences和Shanghai KR Pharmtech为中国临床需求联合开发的产品。基于PhenoImager HT核心技术,特别是Akoya的多光谱成像(MSI)和光谱分解技术,KR-HT5将为临床医生提供高通量平台,以实现对多重生物标志物工作流程的分析。

Shanghai KR Pharmtech will offer the KR-HT5 as part of its Next Generation Pathology (NGP) solutions. 'We are honored and excited to collaborate with Shanghai KR Pharmtech to develop KR-HT5 with our PhenoImager HT core technology and launch the Next Generation Pathology initiative,' expressed Brian McKelligon, CEO of Akoya Biosciences.

上海KR Pharmtech将提供KR-HT5作为其下一代病理学(NGP)解决方案的一部分Akoya Biosciences首席执行官布莱恩·麦凯利根(BrianMcKelligon)表示,我们很荣幸和兴奋能与上海KR Pharmtech合作,利用我们的PhenoImager HT核心技术开发KR-HT5,并启动下一代病理学计划。

“We are very pleased to see that KR-HT5 has received NMPA premarket approval, and we will leverage Akoya's research capabilities and experience in spatial omics, combined with our understanding and work in the Ch.

“我们很高兴看到KR-HT5已获得NMPA上市前批准,我们将利用Akoya在空间组学方面的研究能力和经验,并结合我们在Ch的理解和工作。

推荐阅读

医疗设备研发商Akoya Biosciences和NeraCare签订独家协议,为早期黑色素瘤患者提供个性化治疗选择

GlobeNewswire 2024-05-09 19:58

Akoya Biosciences在AACR年会上展示了空间生物学2.0解决方案,案例研究展示了前所未有的速度和规模

GlobeNewswire 2024-04-05 20:00

Akoya Biosciences指定BostonGene为合格CRO服务提供商

businesswire 2024-03-19 17:59

GlobeNewswire

8153篇

最近内容 查看更多

飞利浦在心律年会上展示研究结果,展示其人工智能心脏监测解决方案的优势

6 小时后

QuTEM获得瑞典医疗产品管理局颁发的透射电子显微镜实验室GMP证书和生产许可证

4 小时后

Erasca宣布RAS特许经营战略许可

2 小时前

相关公司查看更多

Akoya Biosciences

医疗设备研发商

立即沟通

产业链接查看更多

所属赛道

治疗设备
近30天,融资2起
肾神经阻断疗法(RDN)介入治疗未控高血压的有效性已基本被证实,RDN有望满足顽固性高血压(RH)及药物不依从的未控高血压患者(UH)的较大需求,一经出世便受到广泛关注。