Bionano Laboratories Receives College of American Pathologists (CAP) Accreditation for its Clinical Laboratory
16 Agosto 2023 - 9:00AM
Bionano Laboratories, a laboratory services business of Bionano
Genomics, Inc. (Nasdaq: BNGO), today announced that it has received
Laboratory Accreditation from the College of American Pathologists
(CAP) for its Clinical Laboratory Improvement Amendments
(CLIA)-certified reference lab. CAP accreditation is awarded to
laboratories that meet stringent requirements and maintain the
highest standards for laboratory operations of quality, accuracy,
and consistency, as outlined by CAP.
CAP accreditation is often required for a clinical service
provider to become part of insurance companies’ preferred provider
networks for reimbursement. It is also a credential that is
frequently sought after by pharmaceutical and biotechnology
companies who desire their projects to be conducted under a more
robust regulatory structure, especially if the data are intended to
be used for a submission to the U.S. Food and Drug
Administration.
“I’m proud of the work our team has conducted to first develop
CAP and CLIA compliant policies, procedures and practices with the
highest level of quality, and then to be able to successfully pass
such a rigorous inspection like the one CAP conducts,” commented
Alka Chaubey, PhD, FACMG, chief medical officer of Bionano.
“I want to congratulate Alka and the team at Bionano Labs for
achieving this milestone. I believe it will help us support the
proliferation of optical genome mapping (OGM) in a number of
markets, including the cell and gene therapy markets where we
believe OGM can offer significant value as part of the quality
control for cell bioprocessing,” added Erik Holmlin, PhD, president
and chief executive officer of Bionano.
About Bionano Laboratories:
Bionano Laboratories provides access to genetic answers and
support utilizing cutting-edge technologies to advance the way the
world sees the genome. Its clinical services offer a genetic
testing experience that combines a comprehensive testing portfolio
with thoughtful and accessible support options for the diagnostic
journey. Bionano Laboratories also offers direct access to optical
genome mapping for applications across basic, translational and
clinical research. For more information, visit
www.bionanolaboratories.com
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.
Except as otherwise specifically identified, 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,” “will” 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 ability and utility of the CAP accreditation for Bionano
Laboratories to result in being added to the preferred provider
networks of any insurance companies; the ability and utility of the
CAP Accreditation to drive additional business with pharmaceutical
or biotechnology companies; whether the CAP accreditation will
support the proliferation of OGM in any markets, including the cell
and gene therapy markets; and whether OGM will offer significant
value as part of the quality control for cell bioprocessing. 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 potential future
bank failures, the ongoing Ukraine-Russian conflict and related
sanctions, and any global pandemics, on our business and the global
economy; the failure of the CAP accreditation to impact Bionano
Laboratories being added to additional preferred provider networks;
the failure of the CAP accreditation to drive additional business
with pharmaceutical or biotechnology companies; the expansion and
utility of OGM; 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; 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.
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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