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Bionano Announces Second OEM Partner has Received China NMPA Approval for DNA Extraction and Labeling Products for IVD Use of OGM in Reproductive Health
Bionano original equipment manufacturing (OEM) partner A-smart MedTech (A-smart) obtained reagent class I registration and approval for DNA isolation and
About this update from Bionano Genomics, Inc.
[{"type":"text","content":"Bionano original equipment manufacturing (OEM) partner A-smart MedTech (A-smart) obtained reagent class I registration and approval for DNA isolation and labeling kits for optical genome mapping (OGM) from China's National Medical Products Administration (NMPA)Reagents can be utilized for in vitro diagnostics (IVD) use in reproductive health in ChinaWith this NMPA registration, A-smart can sell OGM reagents to independent clinical laboratories and Chinese hospitals SAN DIEGO, Aug. 28, 2023 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced that its Chinese original equipment manufacturing (OEM) partner, A-smart MedTech (A-smart), an assisted reproductive technology company, has obtained reagent class I registrations from China's National Medical Products Administration (NMPA) for Bionano's DNA extraction kit and labeling products. A-smart is Bionano’s second Chinese OEM partner to obtain approval from NMPA for the Company’s optical genome mapping (OGM) solutions. NMPA issued two approvals to A-smart: one for Bionano’s G2 direct label and stain (DLS) DNA labeling kit and one for Bionano’s G2 SP bone marrow aspirate (BMA) DNA isolation kit. A-smart received IVD Class I labels, enabling these reagents to be used for in vitro diagnostics in China. “As a company focused on reproductive medicine, A-smart has been exploring cutting-edge technology to help our customers to achieve a better overall success rate of in vitro fertilization. We believe Bionano’s platform can help us achieve this goal as it helps identify structural variations in a more precise way and on a much broader scale. We are happy to be off to a good start with the NMPA certificate and are looking forward to the next milestones,” commented Zhuo Li, PhD, chief technology officer at A-smart. Erik Holmlin, PhD, president and chief executive officer of Bionano, commented, “We want to congratulate A-smart, our second OEM partner to receive NPMA approval for our reagents. We believe the expansion of NMPA approvals can help make OGM available to China’s large population seeking support for reproductive health, including genetic analysis of people considering pregnancy, pre-implantation analysis of in vitro fertilized embryos, and other prenatal and postnatal genome analyses, which we believe will help Bionano grow sales of the Company’s OGM systems in...