Bionano Laboratories Announces Publication of the Analytical Validation of its OGM-Based Laboratory Developed Test for Hematological Malignancies and Additional Multi-Site Technical Evaluation of OGM
13 December 2023 - 12:00AM
Bionano Laboratories today announced the publication of a study
covering the analytical validation of its laboratory developed test
(LDT), marketed as OGM-Dx™ HemeOne. This LDT is based on optical
genome mapping (OGM) analysis of blood or bone marrow samples to
detect structural variants (SVs) of diagnostic and prognostic
utility in individuals with a new or an existing diagnosis of a
hematological malignancy. The publication also included a
multi-site peer-reviewed IRB-approved analytical validation study
of OGM for the analysis of hematological malignancy samples,
conducted by researchers at laboratories including Bionano
Laboratories, Augusta University, University of Rochester Medical
Center, and Children’s Hospital Los Angeles.
In the study, researchers collaboratively defined a workflow for
the analysis of hematological malignancies using OGM, and
established protocols for analysis and interpretation using
guidelines-based targeted variant assessment, in addition to a
whole-genome analysis. The OGM-Dx HemeOne LDT was then validated at
one site for concordance, sensitivity, specificity, lower limit of
detection, increased diagnostic yield, and assay robustness, using
samples from 60 cases with hematological malignancies (with various
disease subtypes), 2 cancer cell lines, and 18 controls, generating
a total of 215 datasets. Subsequently, the OGM workflow was applied
at the other three sites, showing high levels of reproducibility
across the sites.
The study authors found that OGM is a viable alternative to
traditional cytogenetic methods, such as KT, FISH, and CMA, due to
its ability to detect all classes of SVs, with the highest
resolution of any cytogenetic method in clinical research use, and
to improve diagnostic yield. The authors also noted OGM’s simple
and efficient end-to-end workflow, which may offer researchers
streamlined analysis and lab adoption.
Key findings of the analytical validation of the LDT:
- The OGM-Dx HemeOne LDT demonstrated
100% concordance with traditional methods in the detection of SVs
and 100% concordance in the detection of more complicated
aberrations, such as translocations and inversions, at or
above a 5% variant allele fraction (VAF) threshold
- The OGM-Dx HemeOne LDT was 100%
specific and 100% sensitive for the detection of the set of Tier 1
and Tier 2 variants, as defined by World Health Organization (WHO)
and National Comprehensive Cancer Network (NCCN) guidelines for
comprehensive evaluation of hematologic malignancies
- The OGM-Dx HemeOne LDT resolved
structures in complex genomes, effectively consolidating the
results of three orthogonal technologies (KT, FISH and CMA)
- In 28% of cases (17 out of 60), OGM
identified additional pathogenic variants not previously reported
by traditional methods
Finally, as part of the multi-site analytical study of OGM
performance,14 cases and 10 controls were run and analyzed using
the same OGM workflow at three outside laboratories. The results of
this evaluation showed reproducible concordant performance of 96.4%
across all sites, operators, and samples.
“We are pleased to see the clinical validation of Bionano
Laboratories' OGM-Dx™ HemeOne LDT, analyzing its potential to serve
as a first-tier cytogenetic test for heme malignancies. We believe
that our LDT can provide a comprehensive evaluation of genome wide
SVs that will allow oncologists to assess the best potential
therapies for their malignancy patients,” stated Justin Leighton,
vice president of laboratory business at Bionano Laboratories. “The
study authors also noted that OGM can be easily implemented in the
clinical setting and can substantially reduce operational
complexity and improve the detection rate of pathogenic SVs and may
provide a reproducible and robust alternative to traditional
cytogenetic methods in routine workup of most hematological
malignancies.”
The publication can be viewed here.
About Bionano Laboratories:
Bionano Laboratories provides access to genetic answers and
support utilizing cutting-edge technologies to advance the way you
see the genome. Our clinical services offer a genetic testing
experience that combines a comprehensive testing portfolio with
thoughtful and accessible support options for the diagnostic
journey. Bionano Laboratories also offers direct access to optical
genome mapping for applications across basic, translational and
clinical research. For more information, visit
www.bionanolaboratories.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 “believe,” “can,” “may,” “potential,” “will,”
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 the OGM-Dx™ HemeOne
LDT for the diagnostic and prognostic utility in individuals with a
new or an existing diagnosis of a hematological malignancy; the
ability and utility of the OGM-Dx HemeOne LDT to allow oncologists
to assess the best potential therapies for their malignancy
patients; the ability of the OGM-Dx HemeOne LDT to detect
structural variants (SVs) as compared to traditional cytogenetic
techniques; the ability of OGM to be easily implemented in clinical
settings; and the ability of OGM-based LDTs to remove barriers for
OGM adoption in clinical and research settings. 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 adverse geopolitical and
macroeconomic events, such as recent and potential future bank
failures, potential global pandemics and the ongoing conflicts
between Ukraine and Russia and Israel and Hamas, on our business
and the global economy; general market conditions; the failure of
the OGM-Dx HemeOne to prove useful for the diagnostic and
prognostic utility in individuals with a new or an existing
diagnosis of a hematological malignancy; the failure of the OGM-Dx
HemeOne LDT to detect SVs as compared to traditional cytogenetic
techniques; the failure of the OGM-Dx HemeOne LDT to allow
oncologists to assess the best potential therapies for their
malignancy patients; the failure of OGM to be easily implemented in
clinical settings; the failure of OGM-based LDTs to remove barriers
for OGM adoption in clinical and research settings; the ability of
the OGM workflow to offer the anticipated benefits for and
contributions to the areas reported in the study results referenced
in this press release; future study results contradicting the study
results reported in the publication referenced in this press
release; 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 the
ability of our parent corporation, Bionano Genomics, Inc., to
continue as a “going concern”; the ability of medical and research
institutions to obtain funding to support adoption or continued use
of our services and technologies; and the risks and uncertainties
associated with our business and financial condition in general,
including the risks and uncertainties described in the filings of
our parent corporation, Bionano Genomics, Inc., with the Securities
and Exchange Commission, including, without limitation, its Annual
Report on Form 10-K for the year ended December 31, 2022 and in
other filings subsequently made by them 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.
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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