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Bionano Announces China NMPA Approval for DNA Extraction and Labeling Products for IVD Use in Hematologic Malignancies
Bionano original equipment manufacturing (OEM) partner Beijing Genome Precision Technology (BGPT) obtained reagent class I registration and approval for DNA
About this update from Bionano Genomics, Inc.
[{"type":"text","content":"Bionano original equipment manufacturing (OEM) partner Beijing Genome Precision Technology (BGPT) obtained reagent class I registration and approval for DNA isolation and labeling kits from China's National Medical Products Administration (NMPA)Reagents can be utilized for in vitro diagnostics use in hematologic malignancies in ChinaWith this NMPA registration, BGPT can sell optical genome mapping (OGM) reagents to independent clinical laboratories (ICLs) while it seeks approval for Bionano’s Saphyr® system SAN DIEGO, Feb. 22, 2023 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (BNGO) today announced that its Chinese original equipment manufacturing (OEM) partner, Beijing Genome Precision Technology (BGPT), a comprehensive molecular diagnostics company, has obtained reagent class I registrations from China's National Medical Products Administration (NMPA) for Bionano's DNA extraction kit and labeling products. NMPA issued three approvals to BGPT: two for Bionano’s direct label and stain (DLS) DNA labeling kits and one for Bionano’s bone marrow aspirate (BMA) DNA isolation kit. The NMPA registrations for Bionano’s products enable these reagents to be used for in vitro diagnostics in China. Eventually, they are expected to help sales and placements of both Bionano’s instruments and reagents in China. “As a molecular diagnostic product company focused on blood tumors, we are very happy to establish a cooperative relationship with Bionano and to jointly explore the blood tumor market. Obtaining the NMPA Class I certificate is only a starting point,” stated Ye Feng, PhD, president and chief executive officer of BGPT. Erik Holmlin, PhD, president and chief executive officer of Bionano, commented, “We are really excited to see our OEM partner BGPT receive NMPA approval for our reagents, which can help make optical genome mapping (OGM) available in China. We look forward to seeing continued progress in the Chinese market.\" About Bionano Genomics Bionano Genomics is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. ...