Bionano Genomics Announces Publication of Landmark Research Study in Myelodysplastic Syndrome Showing OGM Data would Result in Revised Prognostic Risk Classification or Additional Actionable Variants in 28% of Study Participants
August 01 2022 - 4:05PM
Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the
publication of the first study to evaluate the utility of optical
genome mapping (OGM) for myelodysplastic syndrome (MDS)
prognostication. In the peer-reviewed study, published in Leukemia,
researchers from The University of Texas MD Anderson Cancer Center
reported that when OGM was used instead of karyotyping, 17 to 21%
of study subjects had different prognostic risk scores and in 13%
of study subjects additional pathogenic variants were revealed. The
OGM results were also compared to results of a next-generation
sequencing (NGS) panel used for molecular pathology. The comparison
to NGS showed that the utility of OGM above and beyond that of
karyotyping is not provided by NGS.
Corresponding author, Dr. Rashmi
Kanagal-Shamanna, from MD Anderson commented, “The results of
this study demonstrate that we are grossly under-evaluating the
degree of genomic aberrations. Most patients with high-risk MDS are
not responsive to available therapies, pointing to the urgent need
for new therapeutic alternatives that will improve the clinical
outcomes of these patients and better tools to help in that
pursuit. This study underscores the potential for OGM to become a
single-platform cytogenetic tool for structural variant profiling
in indications such as MDS, and shows that when OGM and NGS are
combined, the success rate of finding pathogenic variants is higher
than with any traditional methods in use today."
The study analyzed 101 consecutive, newly diagnosed MDS patients
from a single center within MD Anderson. Multiple analysis methods,
including OGM, karyotyping, fluorescence in situ hybridization
(FISH), chromosomal microarray analysis (CMA) and an 81-gene NGS
panel were used to detect pathogenic structural variants (SVs) and
single nucleotide variants (SNVs) in the samples. The findings
showed that OGM detected nearly twice the number of pathogenic SVs
compared to traditional cytogenetic methods. When the OGM results
were used to calculate prognostic risk scores by the comprehensive
cytogenetic scoring system (CCSS), the risk scores were different
for 21% of study subjects and when the international prognostic
scoring system (IPSS) was used, the risk scores were different for
17% of study subjects. Prognostic risk is a component of disease
management protocols outlined in treatment guidelines followed by
oncologists on a global basis. Proper risk classification can help
improve outcomes, including overall survival.
In addition to driving the reclassification of prognostic risk
in up to 21% of subjects, the results showed that OGM detected
pathogenic variants that traditional methods missed in 13% of
subjects. The researchers suggest that these previously undetected
SVs could provide additional information that oncologists could use
to select therapies and to monitor therapeutic response and disease
progression. Taken together, use of OGM resulted in a different
cytogenetic analysis for 28% of subjects in the study.
The authors also evaluated the utility of combining OGM with NGS
on the same MDS subjects and found that the combination of OGM and
NGS resulted in the detection of at least one clinically
significant clonal abnormality in 97 of 101 cases. In one subject,
the researchers reported detecting a pathogenic SV that otherwise
had no clinically relevant variants detected by NGS or traditional
methods.
“We are thrilled to see the remarkable results from the study,
which we believe illustrate the clinical utility of OGM in MDS.
This study shows that OGM can have higher resolution, be faster and
reveal far more variants than traditional methods alone, attributes
that could impact people’s lives and play a role in disease
management. It also shows that combining OGM with NGS can offer a
workflow that reveals SVs and SNVs in a way that the standard
combination of tools in use today cannot,” commented Erik Holmlin,
PhD, president and chief executive officer of Bionano
Genomics.
The publication is available at:
https://www.nature.com/articles/s41375-022-01652-8
About Bionano Genomics
Bionano 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
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 “can,” “may,” “could, “potential,” “believe,”
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 complement
next generation sequencing NGS in the detection of SVs and SNVs in
MDS, the utility of OGM in determining prognostic scores for MDS,
and the ability of OGM to detect clinically relevant SVs that
traditional cytogenomic methods cannot. 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 the COVID-19 pandemic 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 OGM
to achieve useful complementarity with NGS or to be useful in
determining prognostic scores for MDS; failure of future study
results to support those demonstrated in the paper referenced in
this press release; 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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