Bionano Laboratories Expands its Clinical Testing Menu with Launch of its First OGM-Based Laboratory Developed Test (LDT) for Hematological Malignancies
24 Janeiro 2023 - 10:00AM
Bionano Laboratories today announced the launch of OGM-Dx™
HemeOne™, a laboratory developed test (LDT) 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. Compared to traditional cytogenetic methods, this
OGM-based assay offers a streamlined and improved workflow to
assess pathogenic SVs relevant to hematological malignancies
including Acute Lymphoblastic Leukemia (ALL), Acute Myeloid
Leukemia (AML), B-Cell Lymphoma, Chronic Lymphocytic Leukemia
(CLL), Chronic Myelogenous Leukemia (CML) and Myelodysplastic
Syndrome (MDS).
OGM-Dx HemeOne is the second OGM-based LDT launched by Bionano
Laboratories, following the laboratory’s LDT for
facioscapulohumeral muscular dystrophy (FSHD), which was released
in September 2022. The OGM-Dx HemeOne reports from this LDT will
include a targeted analysis of guidelines-based, disease specific
SVs as well as a whole genome analysis for the detection or
recurrent and novel biomarkers associated with various
hematological malignancy indications.
“We are pleased to see the launch of Bionano Laboratories' LDT
for heme malignancies, which can assist patients in their
diagnostic and prognostic journey. Our laboratory’s robust LDT
validation is designed to provide a comprehensive evaluation of
genome wide SVs that will allow oncologists to assess the best
potential therapies for their malignancy patients. We believe the
continued development of OGM-based LDTs will allow Bionano
Laboratories to help create a roadmap for how OGM might be
leveraged in a clinical setting,” stated Justin Leighton, vice
president of laboratory business at Bionano Laboratories.
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
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, 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.
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.bionanolaboratories.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 “believe,” “can,” “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 OGM-Dx HemeOne to
detect SVs of diagnostic and prognostic utility in individuals with
a new or an existing diagnosis of a hematological malignancy
including ALL, AML, B-Cell Lymphoma, CLL, CML and MDS; 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 geopolitical and macroeconomic developments, such as the
ongoing Ukraine-Russian conflict, and related sanctions, and the
COVID-19 pandemic, on our business and the global economy; the
failure of OGM-Dx HemeOne to detect SVs of diagnostic and
prognostic utility in individuals with a new or an existing
diagnosis of a hematological malignancy including ALL, AML, B-Cell
Lymphoma, CLL, CML and MDS; the failure of OGM-based LDTs to remove
barriers for OGM adoption in clinical and research settings;
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; 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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