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.

Bionano原始设备制造（OEM）合作伙伴Ecobono获得了来自中国国家医疗产品管理局（NMPA）的Bionano用于光学基因组图谱（OGM）的DNA分离试剂盒的I类试剂注册和批准试剂可用于中国的体外诊断（IVD）使用通过此NMPA注册，Ecobono可以将OGM试剂出售给独立的临床实验室和中国医院圣地亚哥，9月。

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.

212023（GLOBE NEWSWIRE）-Bionano Genomics，Inc。（纳斯达克股票代码：BNGO）今天宣布，其中国OEM合作伙伴Ecobono是一家专注于生殖健康产品的分销公司，已获得中国NMPA的试剂I类注册Bionano的DNA分离产品。Ecobono是Bionano的第三个中国OEM合作伙伴，获得NMPA批准Bionano的OGM解决方案。

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.

NMPA已向Ecobono发布了Bionano的SP-G2 DNA分离试剂盒的批准。Ecobono获得IVD I类标签，使试剂能够在中国用于IVD。“Ecobono是一家专注于生殖临床和核酸检测的公司，目前生殖临床研究中的结构变异检测主要包括核型分析，荧光原位杂交（FISH）和其他细胞遗传学方法，以及拷贝数变异等分子微阵列芯片。

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.

新的光学绘图技术或超长分子的第三代测序可以统一临床领域的细胞和分子遗传学方法。高分子量核酸检测已成为新方法成功的关键。由于临床样品的特殊性，所用的试剂和仪器需要经过NMPA的注册和批准。

We are very pleased to work with Bionano on the IVD registration o.

我们非常高兴与Bionano合作进行IVD注册。