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Bionano Genomics Announces Pre-Clinical Evaluation of Optical Genome Mapping by the Foundation for Embryonic Competence

Wed 14th April, 2021 1:00pm
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SAN DIEGO, April 14, 2021 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq:
BNGO) announced the launch of an IRB-approved preclinical evaluation study
using optical genome mapping (OGM) by the Foundation for Embryonic Competence
(FEC) based in Basking Ridge, NJ. FEC is a nonprofit organization providing
preimplantation embryo diagnostic tests for patients who are undergoing in
vitro fertilization (IVF).

In the study, FEC will use OGM with the Saphyr system as a research tool to
analyze the genomes of couples who have experienced recurrent pregnancy loss
or recurrent embryo implantation failure. The study’s objective is to
determine whether the improved resolution of OGM, compared to traditional
methods, can identify structural rearrangements that could form the basis of
downstream targeted testing the embryos before implantation, and thereby
potentially lead to improved outcomes of the IVF procedure.

Richard T. Scott, Jr, MD, HCLD FACOG, Founding Partner of IVIRMA Global and
the Clinical Director, Andrology and Endocrinology Laboratory Director, of
RMANJ said, “This study is anticipated to demonstrate the improvements in
the structural variation detection in couples when there is difficulty to
conceive, or where there is recurrent pregnancy loss or unexplained failure
during embryo preimplantation. In such cases, the genome of the parents is
usually analyzed to identify structural variants in the genome that can
predispose to failed pregnancies after which embryos created through IVF can
be screened for unbalanced derivatives”.

Better preimplantation testing can reduce the risk of having a child with a
genetic condition and may improve significantly the pregnancy and delivery
rate per embryo transfer. Currently, karyotyping is the standard of care
method to identify structural variants in the parents, but this methodology
has a low resolution and is imprecise. “The utility of OGM is being
evaluated to comprehensively characterize the structural variations in the
genome, including balanced translocations and inversions. The added advantage
is the ability to identify cryptic structural variations typically missed by
standard of care methods,” said Chaim Jalas, CTO of FEC labs.

“The preclinical IRB approved validation study of OGM by FEC for IVF
applications is an example of what we are seeing as continued, ongoing growth
of the numerous applications for OGM”, commented Erik Holmlin, PhD, CEO of
Bionano Genomics. “FEC’s plan to evaluate the utility of OGM for IVF
procedures adds yet another application for OGM, one that may help the
thousands of couples in the US that undergo IVF procedures every year to have
a successful pregnancy and a healthy child, despite a family history of
genetic disease, infertility or pregnancy loss.”

About Bionano Genomics
Bionano is a genome analysis company providing tools and services based on its
Saphyr system to scientists and clinicians conducting genetic research and
patient testing, and providing diagnostic testing for those with autism
spectrum disorder (ASD) and other neurodevelopmental disabilities through its
Lineagen business. Bionano’s Saphyr system is a research use only platform
for ultra-sensitive and ultra-specific structural variation detection that
enables researchers and clinicians to accelerate the search for new
diagnostics and therapeutic targets and to streamline the study of changes in
chromosomes, which is known as cytogenetics. The Saphyr system is comprised of
an instrument, chip consumables, reagents and a suite of data analysis tools.
Bionano provides genome analysis services to provide access to data generated
by the Saphyr system for researchers who prefer not to adopt the Saphyr system
in their labs. Lineagen has been providing genetic testing services to
families and their healthcare providers for over nine years and has performed
over 65,000 tests for those with neurodevelopmental concerns. For more
information, visit www.bionanogenomics.com or www.lineagen.com.

Forward-Looking Statements

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: improvements in IVF procedures attributable to
research conducted with OGM; the results of the FEC’s study; potential
improvements in preimplantation testing and overall results of such
improvements; and the execution of Bionano’s strategy. 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 actual study results may not
demonstrate the anticipated benefits; 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; 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; the loss of key members of management and
our commercial team; 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.

CONTACTS
Company Contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
eholmlin@bionanogenomics.com

Investor Relations and 
Media Contact:
Amy Conrad
Juniper Point
+1 (858) 366-3243
amy@juniper-point.com



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