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 genome mapping (OGM) from China's National Medical Products Administration (NMPA)
• Reagents can be utilized for in vitro diagnostics (IVD) use in China
• With 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 NMPA approvals can help make OGM available for research into reproductive health in China, an important market for both Bionano and Ecobono."

About Bionano

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 ,  or .

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 ability of new optical mapping technologies or third-generation sequencing of ultra-long molecules to unify cellular and molecular genetic approaches in the clinical field; the achievement of future milestones by Ecobono in its partnership and registration strategy with Bionano; 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 China and the ultimate success of our OEM partners; and the expected growth of sales of the Company’s OGM systems in China. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as recent and potential future bank failures, the ongoing Ukraine-Russian conflict, and related sanctions, and any global pandemics, on our business and the global economy; execution of our stated strategies and plans, including those related to our OEM partners in China; general market conditions; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts and our ability to continue as a “going concern”; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; failure of our OGM solutions to be adopted for the analysis of samples for reproductive health applications; failure of our OGM solutions to provide the anticipated benefits in the identification of structural variants relevant to reproductive health; failure of our OEM partners to execute on their commercial plans; failure of NMPA approvals to drive adoption or use of our OGM solutions for reproductive health applications; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2022 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACTS

Company Contact:

Erik Holmlin, CEO

Bionano Genomics, Inc.

+1 (858) 888-7610

Investor Relations:

David Holmes

Gilmartin Group

+1 (858) 888-7625