University Hospitals Leuven in Belgium Outlines their Menu Expansion Plans for Optical Genome Mapping as One of their Primary Analyses in Leukemias & Lymphomas and Genetic Disease
December 23 2021 - 8:00AM
Bionano Genomics, Inc. (BNGO), pioneer of optical genome mapping
(OGM) solutions on the Saphyr® system and provider of the leading
software solutions for visualization, interpretation and reporting
of genomic data, today announced that University Hospitals Leuven
in Belgium, after previously receiving its accreditation from the
Belgian Accreditation Body (BELAC) for using OGM in analysis of
acute lymphoblastic leukemia (ALL), is expanding its
BELAC-accredited menu to include acute myeloid leukemia (AML),
chronic lymphocytic leukemia (CLL) and facioscapulohumeral muscular
dystrophy (FSHD).
“With the flexibility we now have as an accredited laboratory by
BELAC, our teams can develop OGM-based assays addressing
hematological malignancies without the need for a new audit,” said
Barbara Dewaele, PhD, supervisor of the Laboratory for Genetics of
Malignant Disorders at University Hospitals Leuven. “We are excited
to move forward using this valuable tool to analyze the genomes of
patients with cancer and rare diseases.”
At the European Cytogenomics Conference in July 2021, Dr.
Dewaele shared the results of implementing an OGM-based assay for
ALL patients that her team developed with Bionano’s Saphyr® system.
As presented by Dr. Dewaele and her team, compared to their
existing workflow, the new workflow including OGM as a primary
analysis method reduced the number of fluorescence in-situ
hybridization probes used by 90% and eliminated the need for
multiplexed ligation polymorphism assays. In their new workflow
including OGM, it is complemented with karyotyping to detect ploidy
changes and the presence of small subclones. This transformation
resulted in a turnaround time that was 14 days faster, a cost
savings of approximately 50% and higher overall success rates in
finding pathogenic variants in samples.
In parallel, as part of their menu expansion efforts, and under
the direction of Dr. Valérie Race, Center for Human Genetics at
University Hospitals Leuven, a validation of Bionano’s EnFocus™
FSHD tool will be conducted on a prospective cohort of FSHD samples
to confirm OGM’s capability to accurately measure the length of
D4Z4 repeat arrays and assess reproducibility and repeatability of
the workflow. Preliminary results were presented at the European
Society of Human Genetics conference in August 2021, and reported
that OGM can be a powerful and robust technique for FSHD testing in
genetic diagnostic laboratories by providing results that are
concordant with the current gold standard, Southern blot analysis
in a substantially simpler workflow that does not use
radioactivity.
Dr. Dewaele reported that she and her colleagues have doubled
their weekly sample volume relative to when they first started
using their Saphyr system and believe they are on track to reach
their goal of 500 samples per year with this instrument. The teams
at University Hospitals Leuven believe that the time and cost
savings from using OGM-based assays could be a competitive
advantage relative to traditional techniques. OGM is also
complementary to many of the tools used in typical molecular
pathology and cytogenomics labs and, as a result, it can be helpful
to interpretation of results from assays such as karyotyping, which
can be used to confirm OGM findings.
Erik Holmlin, PhD, President and CEO of Bionano Genomics,
commented, “We are impressed at the drive and persistence of Dr.
Dewaele and all of the teams at Leuven, which has enabled the
hospital to expand its lab testing portfolio. We are thrilled that
University Hospitals Leuven has determined its plans for menu
expansion, which are facilitated by the accreditation and formal
confirmation letter received from BELAC. We believe that the path
followed by Dr. Dewaele is indicative of what other labs can follow
along the way to making OGM an essential and widely used method in
clinical genomics research,” said Dr. Holmlin. “OGM can allow new
workflows that are faster and provide answers to questions quickly,
which may allow for treatment decisions to be taken sooner. Since
OGM has been shown to find clinically relevant variants that other
techniques may miss, it may also provide answers to questions
researchers may not know they had about these specific cancers and
genetic diseases.”
Dr. Barbara Dewaele will be presenting at Bionano’s Symposium on
January 11, 2022. At the Symposium, more than 25 esteemed speakers
from around the world will present their latest scientific findings
using Bionano’s Saphyr system for OGM in constitutional
cytogenomics, hematologic malignancies, solid tumors, and in
combination with next-generation sequencing. A link to register for
the Bionano Genomics 2022 Symposium is available at
https://www.labroots.com/ms/virtual-event/bngo2022
About Bionano Genomics
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 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 “may,” “will,” “expect,” “plan,” “anticipate,”
“estimate,” “intend” 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 inability or
delays in the University Hospitals Leuven to expand its menu; the
inability for other labs to utilize the steps taken by University
Hospitals Leuven to make OGM a widely used method; the ability for
University Hospitals Leuven to continue processing the increased
volume of samples; OGM’s ability to provide new, faster workflows;
OGM’s ability to find clinically relevant variants that other
techniques miss and to provide answers to questions not yet asked;
Dr. Dewaele’s ability to present at Bionano’s Symposium; and the
impact of the expansion of our commercial leadership team,
including our expectations regarding the growth of
Saphyr® and our ability to bolster customer
support and experience globally. 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 products,
technologies or improvements in existing technologies; failure of
OGM to accurately and consistently perform as observed by
University Hospitals Leuven or others; subsequent results could
negate the results observed by University Hospitals Leuven or
others; 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, 2020 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
Media Relations:Michael SullivanSeismic+1 (503)
799-7520michael@teamseismic.com
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