Bionano Announces Publication Demonstrating Utility of OGM as an Alternative to KT and CMA for Evaluating CRISPR-Edited Cells as Part of Stem Cell Therapy Development
30 Agosto 2023 - 9:00AM
Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a
publication in Nature Communications demonstrating the utility of
optical genome mapping (OGM) as an alternative to karyotyping (KT)
and chromosomal microarray (CMA) for the evaluation of CRISPR-Cas9
edited human induced pluripotent stem cell (iPSC) lines in order to
uncover possible pathogenic structural alterations that may limit
their usefulness for stem cell therapy.
The study authors found that approximately 15% of CRISPR-Cas9
edited genomes (2 of 13) had potentially pathogenic large
chromosomal deletions at unexpected off-target sites. In addition
to those two off-target deletions, the authors reported a large,
unexpected deletion at the target site.
“This study is an example of how OGM can be used as part of
developing cell and gene therapies, including stem cell
therapies. The expansion of iPSC-mediated cell therapy faces
risks due to off-target structural variations that may be
introduced during CRISPR-Cas9 genome editing. Since genome
aberrations caused by CRISPR-Cas9 editing could lead to unforeseen
adverse effects, we believe careful and comprehensive analysis of
edited genomes is important in developing these therapies and their
manufacture," commented Erik Holmlin, PhD, president and chief
executive officer of Bionano.
The paper is available
at: https://www.nature.com/articles/s41467-023-40901-x.
About BionanoBionano 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
technology. For more information, visit www.bionano.com,
www.bionanolaboratories.com or www.purigenbio.com.
Unless specifically noted otherwise, Bionano’s OGM products
are for research use only and not for use in diagnostic
procedures.
Forward-Looking Statements of Bionano
Genomics
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as “believe,” “can,” “could,” 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 potential utility of OGM in uncovering
possible pathogenic structural alterations in CRISPR-Cas9 edited
genomes; the utility and ability of OGM to be used as part of
developing cell and gene therapies, including stem cell therapies;
the importance of comprehensive analysis of edited genomes in order
to develop cell and gene therapies, including stem cell therapies,
and their manufacture; and our ability to drive adoption of OGM and
our technology solutions to be used as part of developing cell and
gene therapies including stem cell therapies. 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 timing and amount of revenue we are able to
recognize in a given fiscal period; the impact of adverse
geopolitical and macroeconomic events, such as recent and potential
future bank failures, global pandemics and the ongoing conflict
between Ukraine and Russia, on our business and the global economy;
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; study results that differ or contradict the
results mentioned in this press release; failure of OGM to prove
useful in uncovering possible pathogenic structural alterations in
CRISPR-Cas9 edited genomes; failure of OGM to be used as part of
developing cell and gene therapies including stem cell therapies;
failure of 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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