Bionano Announces Publication of First Multi-Site Study to Analyze the Utility of OGM in Multiple Myeloma
July 23 2024 - 8:00AM
Bionano Genomics, Inc. (Nasdaq: BNGO), today
announced the publication of the
first multi-site study in multiple
myeloma (MM) comparing optical genome mapping (OGM)
to traditional cytogenetic methods for the detection of
structural variants (SVs).
Multiple myeloma is a type of blood cancer originating in the
plasma cell, known as a plasma cell neoplasm (PCN), and though
sensitive and accurate identification of genetic abnormalities in
MM samples is critical for patient risk stratification, predication
of response to therapy options, and understanding of pathogenesis,
many genome analysis methodologies, including fluorescence in situ
hybridization (FISH) and chromosomal microarray (CMA), are limited
in their ability to detect complex gene rearrangements in PCN
samples. Additionally, karyotype (KT) fails for PCNs at a higher
rate than for leukemias because plasma cells are fragile and grow
poorly in culture, leaving additional unmet need. Because OGM
doesn’t require culture, it may be well suited to fill this
gap.
In this study, conducted by researchers at University of Texas
MD Anderson Cancer Center and The Johns Hopkins Hospital,
researchers concurrently analyzed 45 PCN samples using KT, FISH,
OGM, and next-generation sequencing (NGS). OGM uniquely identified
complex genomic rearrangements that are associated with cancer
proliferation and progression, resulting in a change in
prognostication beyond that indicated by traditional cytogenetic
analysis in 18% of cases. In at least five cases (11%), OGM’s
unique findings provided precise information to predict response to
target therapies like BCMA monoclonal antibody, CAR-T, or GPRC5D
targeted therapies, which may have therapeutic implications. The
study results highlight OGM’s ability to provide researchers with a
highly sensitive, accurate genome-wide analysis that can lead to a
more comprehensive understanding of genetic subtypes in PCN when
compared with FISH and KT.
Key findings:
- Compared to FISH, OGM achieved 100%
sensitivity, specificity, and accuracy in cases after CD138
selection and 96.6% sensitivity, 100% specificity, and 98.3%
accuracy in unselected cases
- OGM detected gains of chromosome 1q in
several samples, a known high-risk factor in MM
- OGM revealed 18 hyperdiploidy, 4
hypodiploidy, and 9 IGH or MYC rearrangements undetected by
FISH
- In 18% of cases (8 out of 45), OGM
identified chromoanagenesis that was undetected by FISH
- In 18% of cases (8 out of 45), OGM
changed the prognostication beyond that indicated by standard
cytogenetics/FISH analysis
- OGM detected 366 novel structural
variants and copy number variants that are potentially relevant to
the formation and development of MM
“Though many research studies demonstrate OGM’s utility in
leukemias and other blood cancers, we were pleased to see robust
findings from the first multi-site study of OGM in multiple
myeloma, which is a blood cancer that is more difficult for
researchers to assess. OGM has the potential to identify
pathogenically relevant variants missed by other methods that
further our understanding of MM, which we believe may lead to
greater adoption of the workflow in labs focused on cancer
research,” commented Erik Holmlin, PhD, president and chief
executive officer of Bionano.
The publication can be viewed here.
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 optical genome
mapping (OGM) solutions, diagnostic services and software. The
Company offers OGM solutions for applications across basic,
translational and clinical research. The Company also offers an
industry-leading, platform-agnostic genome analysis software
solution, and nucleic acid extraction and purification solutions
using proprietary isotachophoresis (ITP) technology. Through its
Lineagen, Inc. d/b/a Bionano Laboratories business, the Company
also offers OGM-based diagnostic testing services.
For more information,
visit www.bionano.com or www.bionanolaboratories.com.
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 “ability,”
“believe,” “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 and utility of OGM to detect SVs
missed by other cytogenetic methods, including KT, FISH, and CMA;
the ability and utility of OGM to provide highly sensitive,
accurate genome-wide analysis, that can lead to a more
comprehensive understanding of genetic subtypes in PCN when
compared with FISH and KT; the ability and utility of OGM to detect
SVs relevant to multiple myeloma; the ability of OGM to provide
results that are concordant traditional methods, including FISH and
KT; the ability of OGM to detect SVs that are relevant to
prognostication; 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 conflicts between Ukraine and Russia and
Israel and Hamas, and related sanctions, and any global pandemics,
inflation, or supply disruptions, 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; the failure of OGM to detect SVs missed by other
cytogenetic methods, including KT, FISH, and CMA; the failure of
OGM to provide highly sensitive, accurate genome-wide analysis,
that can lead to a more comprehensive understanding of genetic
subtypes in PCN when compared with FISH and KT; the failure of OGM
to detect SVs relevant to multiple myeloma; the failure of OGM to
provide results that are concordant traditional methods, including
FISH and KT; the failure of OGM to detect SVs that are relevant to
prognostication; future study results that contradict or 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; our ability
to effectively manage our uses of cash, and our ability to continue
as a “going concern”; the ability of institutions to obtain funding
to support adoption or continued use of our technologies; 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, 2023 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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