American College of Medical Genetics and Genomics Includes OGM in Latest Edition of Technical Laboratory Standards for Solid Tumor Analysis
February 22 2024 - 8:00AM
Bionano Genomics, Inc. (Nasdaq: BNGO), today announced that
optical genome mapping (OGM) was included for the first time in the
American College of Medical Genetics and Genomics (ACMG) technical
laboratory standards documentation for solid tumor analysis. The
section, which was last updated in 2016, includes an overview of
current cytogenomic techniques for solid tumor analysis and
guidelines for their use, providing structure and standardization
to laboratory geneticists as they perform cytogenomic studies for
solid tumors.
The technical laboratory standards were developed by a working
group of laboratory geneticists performing cytogenetic studies. The
working group conducted a comprehensive review of publications,
current guidelines from organizations including ACMG, National
Comprehensive Cancer Network, Children’s Oncology Group, and the
World Health Organization (WHO), as well as the authors’ own
expertise and empirical data, and their recommendations were voted
on by the ACMG general membership and approved by the
organization’s laboratory quality assurance committee and board of
directors. The authors describe OGM’s utility for genome-wide
analysis, due to its ability to detect and validate structural
variants (SVs) at high resolution in a single assay, as compared to
traditional cytogenetic methods.
“We are thrilled to see OGM included in the newest section of
the ACMG technical laboratory standards for solid tumor studies,
which provides a standardized guide for laboratory geneticists who
are conducting this cytogenomic analysis. ACMG’s laboratory
standards documentation plays an important role in directing the
cancer laboratory community toward emerging techniques, and in
comparing different methods of genome analysis,” commented Alka
Chaubey, PhD, FACMG, chief medical officer of Bionano.
“Inclusion in the ACMG lab standards for solid tumor analysis is
a significant milestone for OGM and for people in the field of
cancer cytogenomics who are looking for ways to move the community
forward. We were pleased to see the authors note OGM’s
ability to detect relevant variants that other methods, including
sequencing, may miss, while citing OGM’s efficient and sensitive
analysis. We believe that cytogenomic analysis of solid tumor
samples is critically important for clinical research,”
added Erik Holmlin, PhD, president and chief executive
officer of Bionano.
The publication can be found here.
About Bionano
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, 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.
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. The Company additionally offers
nucleic acid extraction and purification solutions using
proprietary isotachophoresis technology. For more information,
visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.com.
Unless specifically noted otherwise, Bionano’s OGM products
are for research use only and not for use in diagnostic
procedures.
Forward-Looking Statements of
Bionano
This press release contains forward-looking statements contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as “believe,”
“may,” “potential” and similar expressions (as well as other words
or expressions referencing future events, conditions or
circumstances and the negatives thereof) 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: t
OGM’s ability to detect and validate SVs at high resolution in a
single assay, as compared to traditional cytogenetic methods; the
impact that the inclusion of OGM in the ACMG standards
documentation may have on our business or our opportunities; the
ability and utility of OGM to detect relevant SVs in solid tumor
samples; the ability and utility of OGM to detect relevant variants
that other methods, including sequencing, may miss, and OGM’s
efficient and sensitive analysis; and other statements that are not
historical facts.
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 recent and future bank
failures, the ongoing Ukraine-Russia conflict, related sanctions,
the Israel-Hamas war, and any global pandemics, on our business and
the global economy; challenges inherent in developing,
manufacturing and commercializing products; our ability to further
deploy new products and applications and expand the markets for our
technology platforms; failure of OGM to detect and validate SVs at
high resolution in a single assay, as compared to traditional
cytogenetic methods; failure of the inclusion of OGM in the ACMG
standards documentation to have an impact on our business or our
opportunities; failure of OGM to detect relevant SVs in solid tumor
samples; failure of OGM to be included in other standards
documentation; failure of OGM to detect relevant variants that
other methods, including sequencing, may miss; and failure of OGM
to provide efficient and sensitive analysis; future standards that
contradict or do not support the inclusion of OGM in laboratory
standards; our expectations and beliefs regarding future growth of
the business and the markets in which we operate; changes in our
strategic and commercial plans; our ability to obtain sufficient
financing to fund our strategic plans and commercialization efforts
and our ability to continue as a “going concern”; and 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, 2022
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 are under no duty to update any of these
forward-looking statements after the date they are made to conform
these statements to actual results or revised expectations, except
as required by law. You should, therefore, not rely on these
forward-looking statements as representing our views as of any date
subsequent to the date the statements are made. Moreover, except as
required by law, neither we nor any other person assumes
responsibility for the accuracy and completeness of the
forward-looking statements contained in this press release.
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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