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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.
Posted In: AKYA
