Bionano Announces Second OEM Partner has Received China NMPA Approval for DNA Extraction and Labeling Products for IVD Use of OGM in Reproductive Health
August 28 2023 - 8:00AM
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 China.”
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 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 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.
CONTACTSCompany Contact:Erik
Holmlin, CEOBionano Genomics, Inc.+1 (858)
888-7610eholmlin@bionano.com
Investor Relations:David HolmesGilmartin
Group+1 (858) 888-7625IR@bionano.com
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