Akoya Biosciences and Shanghai KR Pharmtech Announce Chinese Regulatory Agency Premarket Approval for KR-HT5 in China to Support Next Generation Pathology Clinical Workflows
Akoya Biosciences and Shanghai KR Pharmtech have announced that KR-HT5, developed using Akoya's PhenoImager HT technology, has received premarket approval from China's NMPA. This approval will support next generation pathology clinical workflows in China, providing clinicians with a high-throughput platform for multiplex biomarker analysis. Shanghai KR Pharmtech will offer KR-HT5 as part of its Next Generation Pathology solutions.
Development of KR-HT5 with PhenoImager HT technology enhances Akoya Biosciences' product portfolio and market presence in China.
Receiving premarket approval from China's NMPA demonstrates the product's compliance with regulatory standards, increasing its credibility and market acceptance.
KR-HT5's high-throughput platform for multiplex biomarker analysis provides clinicians with advanced tools for pathology workflows, potentially improving diagnostic accuracy and efficiency.
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KR-HT5 is based on Akoya’s PhenoImager® HT Platform
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.
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.
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. 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.
“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 Chinese domestic market, to promote the clinical utilization of Next Generation Pathology solutions,” said Lingbin Bu, CEO of Shanghai KR Pharmtech.
Forward-Looking Statements
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About Akoya Biosciences
As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research: PhenoCode™ Panels and PhenoCycler®, PhenoImager® Fusion and PhenoImager HT Instruments. To learn more about Akoya, visit www.akoyabio.com.
About Shanghai KR Pharmtech
Shanghai KR Pharmtech is a company based in Shanghai, China that specializes in translational research and applications in precision medicine, aiming to provide comprehensive molecular diagnostic solutions for various applications. It provides services to over 500 hospitals and research institutions in China through CAP-accredited medical laboratory, three high-tech enterprises, two research and development centers in Shanghai and Xuzhou, a precision Medicine Technology Research institution, an IVD production factory, and a thirty-thousand square meters Smart Medical Industry Park. Shanghai KR Pharmtech has pioneered the clinical services of NGP (Next Generation Pathology) and NGS (Next Generation Sequencing) within China.
Akoya Investor Contact:
Priyam Shah
Sr. Director, Investor Relations
Akoya Biosciences
investors@akoyabio.com
Akoya Media Contact:
Christine Quern
Akoya Biosciences
+1.617.650.8497
media@akoyabio.com
Shanghai KR Pharmtech Contact:
Rui Zhang
Executive Vice General Manager
Shanghai KR Pharmtech
+86 13817082993
zr@kuorangene.com
