Bionano Announces Publication of Largest Prospective Prenatal Study Comparing OGM to Chromosomal Microarray Analysis and Karyotyping
26 Dicembre 2023 - 2:00PM
Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a
publication covering the largest independent prospective prenatal
study comparing optical genome mapping (OGM) to a combined workflow
of chromosomal microarray analysis (CMA) and karyotyping (KT). The
study highlighted OGM’s high analytical concordance with the
combined workflow of CMA and KT, and its ability to detect novel
pathogenic structural variants (SVs) missed by those methods. The
study also highlighted OGM’s potential to provide additional
information about SVs and copy number variants (CNVs) compared to
CMA and KT.
The study, published by researchers from Nanjing Women and
Children’s Healthcare Hospital in China, reported that OGM
demonstrated robust performance across multiple technical and
analytical metrics when compared to CMA and KT. OGM also revealed
the location and orientation of duplication segments, refined
breakpoints of SVs and identified specific repeat contraction
disorders that were not detected by other methods.
Researchers used 200 unique prospective prenatal samples with
soft markers (including increased nuchal translucency, nasal bone
hypoplasia and mild ventriculomegaly, and structural anomalies) for
the study. Within this prospective cohort, OGM showed a 97.4%
sensitivity, 100% specificity, 100% positive predictive value (PPV)
and 99.4% negative predictive value (NPV) for detecting SVs
reported with KT and CMA. OGM identified several additional SVs not
detected by CMA and KT and defined location and orientation for
eight CNVs, which may help researchers interpret the effect of CNVs
more precisely. OGM also detected 8 D4Z4 repeat contractions on the
permissive 4qA haplotype that may indicate facioscapulohumeral
muscular dystrophy type 1 (FSHD1). The study authors concluded that
OGM has the potential to serve as a first-tier cytogenetic method
for prenatal analysis due to its ability to identify the majority
of pathogenic SVs in a single assay.
“The use of OGM for the analysis of prenatal samples is an area
where we believe our workflow can have
tremendous global impact. We believe this study
marks a milestone in the Chinese prenatal research market as it
includes the largest sample size to date for an independent
prenatal study using OGM. Additionally, it demonstrates the
workflow’s strong performance and potential ability to provide
answers from a single assay compared to the two to three assays
required with the traditional methods commonly used today,”
commented Erik Holmlin, PhD, president and chief executive
officer of Bionano.
The paper is available 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
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,” “could,” “may,”
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 potential ability and utility of OGM to
provide results highly concordant with CMA and KT from prenatal
samples; the potential ability and utility of OGM to detect
potentially pathogenic SVs in prenatal samples missed by CMA and
KT; the potential ability and utility of OGM to provide information
on SVs and CNVs not provided by CMA and KT; the potential ability
and utility of OGM to become a first-tier test for the analysis of
prenatal samples; and our ability to drive adoption of OGM and our
technology solutions to be used as part of the analysis for
prenatal samples. 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 timing and amount of
revenue we are able to recognize in a given fiscal period; the
impact of adverse geopolitical and macroeconomic events, such as
recent and potential future bank failures, global pandemics and the
ongoing conflicts between Ukraine and Russia and Israel and Hamas,
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;
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”; the ability of medical and research institutions to
obtain funding to support adoption or continued use of our
technologies; study results that differ or contradict the results
mentioned in this press release; failure of OGM to provide results
highly concordant with CMA and KT from prenatal samples; failure of
OGM to detect potentially pathogenic SVs in prenatal samples missed
by CMA and KT; failure of OGM to provide information on SVs and
CNVs not provided by CMA and KT; failure of OGM to become a
first-tier test for the analysis of prenatal samples; failure of
our ability to drive adoption of OGM and our technology solutions
to be used as part of the analysis for prenatal samples; failure of
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, 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 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@bionano.com
Investor Relations:David HolmesGilmartin
Group+1 (858) 888-7625IR@bionano.com
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