Multi-Center Research Study Illustrates How OGM Can Potentially Result in More Patients Qualifying for Treatments in Leukemia
09 Dezembro 2022 - 10:00AM
Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the
publication of a multi-institutional peer-reviewed study initiated
by the Cancer Genomics Consortium evaluating the performance of
optical genome mapping (OGM) for detection of cytogenetic
abnormalities in acute myeloid leukemia (AML) samples. OGM
identified structural variants (SVs) and copy number variants
(CNVs) with 100% concordance to traditional cytogenetic methods,
added important pathogenic findings in 13% of findings, and
uncovered additional genomic events in 12% of samples that may
change risk stratification and alter recommended clinical care,
including access to clinical trials.
Given the consistent correlation of clinical outcomes with
specific genomic aberration classes, the World Health Organization
(WHO), National Comprehensive Cancer Network (NCCN) and European
Leukemia Net (ELN) have developed recommendations for diagnosis and
management of AML in adults based on the spectrum of CNVs, SVs and
somatic single nucleotide variants (SNVs) detected by traditional
cytogenetic methods. In the study published in Blood Advances,
researchers used OGM to evaluate its performance in the detection
of cytogenetic abnormalities in 100 AML samples that had previously
been analyzed using methods including karyotyping (KT),
fluorescence in situ hybridization (FISH) and chromosomal
microarray analysis (CMA).
Key findings were:
- In five subjects,
analysis by OGM resulted in a change in risk stratification score
compared to the scores determined by KT
- In eight subjects,
OGM identified additional genomic events that would have rendered
those subjects eligible to participate in research studies
evaluating the effectiveness of experimental treatments
- In three of the
subjects that would be eligible to participate in research studies
evaluating the effectiveness of experimental treatments, OGM also
showed that potential adverse risks would be independent of TP53,
which may allow for them to be safely enrolled in multiple trials
with known TP53-related adverse effects
Overall, the research study supports the view that OGM analysis
may be useful to assemble a more accurate and complete karyotype by
refining cytogenetic breakpoints, resolving unknown cytogenomic
elements and detecting additional significant variants.
“We are excited to see the findings from this study, which was
conducted by a multi-site consortium led by renowned pathologists
who, through their memberships in various medical societies, are
responsible for defining standards of care and testing throughout
pathology. We are gratified to see the authors’ recommendation of
OGM as a methodology with the potential to become standard-of-care
for cytogenomic evaluation of AML samples,” commented Erik
Holmlin, PhD, president and chief executive officer of Bionano
Genomics.
The publication is available here.
About Bionano GenomicsBionano Genomics 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 business, the Company also provides diagnostic
testing for patients with clinical presentations consistent
with autism spectrum disorder and other neurodevelopmental
disabilities. Through its BioDiscovery business, 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. For more information, visit
www.bionanogenomics.com, www.lineagen.com or
www.biodiscovery.com
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 “may,” “potential,” “would” 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 ability and utility of OGM to detect cytogenetic abnormalities,
including SVs and CNVs, in AML samples, the ability of OGM to
produce concordant results with traditional cytogenetic methods or
to uncover additional genomic events, the ability and utility of
OGM to analyze genomes and reveal answers in genetic disease and
cancer research, and the potential for OGM to become the standard
of care. 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: global and macroeconomic
events, such as the impact of the COVID-19 pandemic and the ongoing
Ukraine-Russian conflict and related sanctions, 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; failure of
future study results to support those reported in the publication
referenced in this press release; future study results that
contradict the results reported in the publication referenced in
this press release; failure of OGM to produce concordant results
with traditional cytogenetic methods; failure of OGM to uncover
additional genomic events when compared to traditional cytogenetic
methods; failure of OGM to be adopted as a standard of care for
cytogenomic evaluation of AML samples; changes in our strategic and
commercial plans; our ability to obtain sufficient financing to
fund our strategic plans and commercialization efforts; the ability
of medical and research institutions to obtain funding to support
adoption or continued use of our technologies; 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, 2021 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@bionanogenomics.com
Investor Relations:Amy ConradJuniper Point+1
(858) 366-3243amy@juniper-point.com
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