Bionano Announces Peer-Reviewed Publication on the Utility of Combining OGM and WES for Evaluation of Pediatric Leukemia
06 Setembro 2023 - 9:00AM
Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a
peer-reviewed publication from researchers at the German Cancer
Consortium (DKTK) showing the utility of optical genome mapping
(OGM) and whole-exome sequencing (WES) in better understanding the
mutational landscape of pediatric B-cell precursor acute
lymphoblastic leukemia (BCP-ALL). Researchers compared the analysis
of 60 pediatric BCP-ALL samples using traditional cytogenetic
methods against OGM and WES, finding that OGM and WES may provide
novel insights into disease development and progression.
Key Takeaways
- OGM and WES identified 19 recurrently
altered regions with novel potential leukemic drivers
- OGM and WES identified double hits of
structural variants (SVs) and single-nucleotide variants (SNVs)
(ETV6, BTG1, STAG2, MANBA, TBL1XR1, NSD2) in the same sample,
demonstrating the power of the combined approach of OGM and WES to
identify compound events relevant to risk stratification and
treatment of hematological malignancies
- OGM identified 95% of SVs (526 out of
552) detected by karyotyping (KT), fluorescence in situ
hybridization (FISH) and/or single nucleotide polymorphism (SNP)
array, including all hallmark translocations and chromosomal gains
in hyperdiploid (HD) BCP-ALL
- OGM identified 677 additional SVs of
potential clinical relevance not identified by traditional methods,
including SVs in known leukemia development genes and
subclonal IKZF1 deletions missed by SNP-array
- Overall, OGM detected three times more
deletions than were detected by a SNP-array at a 50kb detection
limit
- OGM identified 3 novel fusion genes
(SFMBT2::DGKD, PDS5B::STAG2, and TDRD5::LPCAT2)
- PacBio long-read sequencing was
performed on 11 tumor samples where sufficient material was
available to validate selected SVs that were newly detected by
OGM
- The combination of KT, FISH and
SNP-array detected only 43% of SVs that OGM detected
“This peer-reviewed publication from a leading German cancer
consortium outlines the utility of OGM for detecting SVs that
current methods identify and for revealing ones that current
methods miss. It also shows the potential of combining OGM with WES
to identify double hits, which are highly significant. It’s
noteworthy that long-read sequencing confirmed the fusions detected
by OGM once OGM revealed the regions in which to look for them,
highlighting the possibility that OGM can be a primary tool used
alongside short-read next-generation sequencing (NGS). Altogether,
the findings may result in meaningful revisions to various risk
classifications and disease stratifications, which are known to
affect outcomes,” commented Erik Holmlin, president and chief
executive officer of Bionano.
The publication can be viewed here:
https://journals.lww.com/hemasphere/fulltext/2023/08000/optical_genome_mapping_identifies_novel_recurrent.4.aspx
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 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
This press release contains forward-looking statements contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as “can,”
“may,” “potential,” and similar expressions (as well as other words
or expressions referencing future events, conditions or
circumstances and the negatives thereof) 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 ability of OGM and WES to provide novel insights into disease
development and progression; the performance of OGM compared to
traditional cytogenetic methods including KT, FISH, and SNP-arrays
for the identification of SVs; the ability and utility of OGM to
detect SVs in BCP-ALL samples; the potential of combining OGM with
WES to identify double hits; the ability and utility of combining
OGM with WES for the analysis of BCP-ALL samples; the ability and
utility of OGM to be adopted as an analysis method for BCP-ALL
samples; the possibility that OGM can be a primary tool used
alongside NGS; whether the findings discussed in this press release
will result in meaningful revisions to various risk classifications
and disease stratifications; and other statements that are not
historical facts.
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 future bank
failures, the ongoing Ukraine-Russia conflict, related sanctions,
and any global pandemics, on our business and the global economy;
challenges inherent in developing, manufacturing and
commercializing products; our ability to further deploy new
products and applications and expand the markets for our technology
platforms; failure of OGM and WES to provide novel insights into
disease development and progression; failure of our OGM solutions
to be adopted for analysis of BCP-ALL samples; the failure of OGM
to be combined with WES for the analysis of BCP-ALL samples and to
detect double hits; the failure of OGM to detect SVs consistent
with the study results described in this press release; the failure
of OGM to be used as a primary tool alongside NGS; the failure of
the study results discussed in this press release to result in
meaningful revisions to various risk classifications and disease
stratifications; future study results that contradict the study
results described in this press release; future study results that
do not support the study results described in this press release;
our expectations and beliefs regarding future growth of the
business and the markets in which we operate; 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”; and 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 are under no duty to update any of these
forward-looking statements after the date they are made to conform
these statements to actual results or revised expectations, except
as required by law. You should, therefore, not rely on these
forward-looking statements as representing our views as of any date
subsequent to the date the statements are made. Moreover, except as
required by law, neither we nor any other person assumes
responsibility for the accuracy and completeness of the
forward-looking statements contained in this press release.
CONTACTS
Company 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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