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 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
- With this NMPA registration, A-smart can sell OGM reagents to independent clinical laboratories and Chinese hospitals
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
“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
Bionano 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. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. The Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. The Company additionally offers nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. For more information, visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.com.
Unless specifically identified, Bionano’s OGM products are for research use only and not for use in diagnostic procedures.
Forward-Looking Statements of Bionano
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “can,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations, concerning, among other things: the impact and utility of OGM in the analysis of samples for in vitro fertilization or other reproductive health purposes; the impact of NMPA approvals or the adoption of our OGM solutions for reproductive health or other purposes; the anticipated benefits of Bionano’s platform for our OEM partners in
+1 (858) 888-7610
+1 (858) 888-7625
Source: Bionano Genomics