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Bionano Announces Third OEM Partner has Received China NMPA Approval for DNA Isolation Products for IVD Use of OGM
Bionano original equipment manufacturing (OEM) partner Ecobono obtained reagent Class I registration and approval for Bionano’s DNA isolation kits for optical
About this update from Bionano Genomics, Inc.
[{"type":"text","content":"Bionano original equipment manufacturing (OEM) partner Ecobono obtained reagent Class I registration and approval for Bionano’s DNA isolation 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 ChinaWith this NMPA registration, Ecobono can sell OGM reagents to independent clinical laboratories and Chinese hospitals SAN DIEGO, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced that its Chinese OEM partner, Ecobono, a distribution company focused on reproductive health products, has obtained reagent Class I registration from China's NMPA for Bionano's DNA isolation products. Ecobono is Bionano’s third Chinese OEM partner to obtain approval from NMPA for Bionano’s OGM solutions. NMPA issued an approval to Ecobono for Bionano’s SP-G2 DNA isolation kit. Ecobono received an IVD Class I label, enabling the reagents to be used for IVD in China. “Ecobono is a company that focuses on reproductive clinical and nucleic acid testing. Currently, structural variation detection in reproductive clinical research mainly includes karyotype analysis, fluorescence in situ hybridization (FISH) and other cytogenetic methods, as well as molecules such as copy number variation microarray chips. New optical mapping technologies or third-generation sequencing of ultra-long molecules can unify cellular and molecular genetic approaches in the clinical field. Detection with high molecular weight nucleic acids has become the key to the success of the new methodology. Due to the particularity of clinical samples, the reagents and instruments used need to be registered and approved by NMPA. We are very pleased to work with Bionano on the IVD registration of the Class I reagents. This approval is the first milestone of our partnership. We look forward to more potential milestones for the registration of additional reagents and instruments in the future,” stated Wenli Wang, chief executive officer of Ecobono. Erik Holmlin, PhD, president and chief executive officer of Bionano, commented, “We want to congratulate Ecobono, our third OEM partner to receive NMPA approval for our reagents. This approval is an important first step as Ecobono advances its registration strategy for Bionano products. We believe the expansion of...