Bionano Laboratories Announces New Category I CPT Code for OGM Use in Hematological Malignancy Analysis
17 Juni 2024 - 10:05PM
Bionano Laboratories, a clinical laboratory services business of
Bionano Genomics, Inc. (Nasdaq: BNGO), today announced the
editorial panel of the American Medical Association (AMA)
established a new Category I Current Procedural Terminology (CPT®)
code for the use of optical genome mapping (OGM) in cytogenomic
genome-wide analysis to detect structural and copy number
variations related to hematological malignancies. The CPT code is a
key component in obtaining reimbursement for the OGM-Dx™ HemeOne
laboratory developed test (LDT) from third party payers. The
Category I CPT code is expected to be included in the next CPT
codebook and to be effective January 1, 2025.
The establishment of a new Category I CPT code for OGM implies
that it has met the standards of acceptance by the medical
community, in contrast to a Category III code, which is generally
applied to emerging technologies. As part of the application review
process, the panel collects input from stakeholders across the
health care community to ensure CPT content reflects the coding and
data-driven demands of modern health care.
“We believe this approval of a Category I CPT code for OGM is a
game changer for clinical OGM testing. The criteria that the AMA
uses for Category I CPT code approval is rigorous, and this
approval is significant,” said Donna Polizio, global head of market
access at Bionano Laboratories. “OGM-Dx HemeOne is used to detect
all classes of structural variants that are traditionally tested by
multiple methods such as karyotyping, chromosomal microarray, and
fluorescence in situ hybridization (FISH) analysis. We believe the
CPT code is an important step forward for Bionano Laboratories and
its efforts to obtain reimbursement for this assay and that
establishing a Category I CPT code will raise the awareness and
utility of OGM.”
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 diagnostics services offer
optical genome mapping (OGM) testing that combines a comprehensive
testing portfolio with thoughtful and accessible support options.
Bionano Laboratories also offers direct access to OGM 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 optical genome
mapping (OGM) solutions, diagnostic services and software. The
Company offers OGM solutions for applications across basic,
translational and clinical research. The Company also offers an
industry-leading, platform-agnostic genome analysis software
solution, and nucleic acid extraction and purification solutions
using proprietary isotachophoresis (ITP) technology. Through its
Lineagen, Inc. d/b/a Bionano Laboratories business, the Company
also offers OGM-based diagnostic testing services.
For more information,
visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.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 “believe,” “expect,” 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 Category I CPT code to drive use and adoption of the
OGM-Dx HemeOne test and other OGM-based tests; the ability of the
OGM-Dx HemeOne test to obtain coverage and reimbursement; whether
the Category I CPT code will ultimately be important for clinical
OGM testing; and any other statements that are not of historical
fact. 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 conflicts between Ukraine and Russian
and Israel and Hamans, and related sanctions, and any global
pandemics, on our business and the global economy; the failure of
the Category I CPT code to drive use and adoption of the OGM-Dx
HemeOne test and other OGM-based tests; the failure of the OGM-Dx
HemeOne test to obtain coverage and reimbursement; the failure of
the Category I CPT code to ultimately be important for clinical OGM
testing 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, 2023 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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