Bionano Genomics Announces Launch of CLIA-Certified Bionano Laboratories, and Expands its Clinical Testing Menu with Launch of First OGM-Based LDT for FSHD
September 23 2022 - 8:00AM
Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the launch of
Bionano Laboratories, a new organization that combines Bionano’s
optical genome mapping (OGM) data services with the clinical
testing services previously offered by Lineagen, and the launch of
Bionano Laboratories’ first OGM-based laboratory developed test
(LDT). Bionano Laboratories recently received CLIA-certification
for its lab in San Diego. This certification will enable Bionano
Laboratories to offer services to customers seeking to implement
OGM into their diagnostic routines and for research applications
with hospitals, pharmaceutical companies, and other parties that
may desire a more robust regulatory structure for their projects.
A key strategic objective of Bionano Laboratories’ CLIA lab is
to develop a menu of LDTs based on OGM. The first OGM-based LDT
developed by Bionano Laboratories is a test for facioscapulohumeral
muscular dystrophy (FSHD), which is the second leading cause of
muscular dystrophy and an important marker in the evaluation of
muscular disorders.
“We are excited to launch Bionano Laboratories, which will
enable the ability to scale OGM LDT and research services to meet
increasing market testing demands. We believe our CLIA-certified
lab will help streamline the diagnostic odyssey for clinicians and
their patients, as it will have the potential to detect many
different types of genomic variants in a single diagnostic
environment. This launch is an important milestone for
Bionano, and something we have been working towards since our
acquisition of Lineagen,” commented Dr. Alka Chaubey, chief medical
officer of Bionano Genomics.
Erik Holmlin, PhD, president and chief executive officer
of Bionano Genomics added, “We want to congratulate Alka along
with her outstanding team for all the work they’ve done. The
development of LDTs will allow Bionano Laboratories to introduce
OGM-based assays to interested physicians and to seek reimbursement
from insurance companies for these testing services. We believe our
ability to offer CLIA-certified services will enable us to execute
our growth strategy and to fulfill our vision of changing the way
the world sees the genome.”
More details on Bionano Laboratories is available at:
https://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.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,” “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 utility of OGM-based LDTs, and the ability of Bionano
Laboratories to be successful in the market development of
OGM-based LDTs. 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-based LDTs to provide meaningful
diagnostic utility; failure of clinicians or researchers to add
OGM-based LDTs into their diagnostic routine; 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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