Bionano Laboratories Announces a Second Category I CPT Code for OGM Established by the AMA; this one for Use in Whole Genome Analysis for Constitutional Genetic Disorders
SAN DIEGO, May 19, 2025 (GLOBE NEWSWIRE) -- Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics, Inc. (NASDAQ:BNGO) that offers CLIA-certified laboratory developed tests (LDTs) based on optical genome mapping (OGM), today announced that the editorial panel of the American Medical Association (AMA) established a new Category I Current Procedural Terminology (CPT®) code for the use of OGM in cytogenomic genome-wide analysis to detect structural and copy number variations related to constitutional genetic disorders. The CPT code is a key component in obtaining reimbursement for the OGM-Dx™ Postnatal Whole Genome SV and OGM-Dx™ Prenatal Whole Genome SV LDTs 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, 2026.
The establishment of this CPT code for OGM is the second Category I CPT code issued for OGM and follows code 81195, which was established in 2024 for cytogenomic genome-wide analysis to detect structural and copy number variations related to hematological malignancies. Acceptance of the application for a Category I CPT code in another area of clinical genetic testing with OGM implies that it has met the Category I standards, which are generally considered to be more rigorous than those of Category III codes, which are commonly 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 the approval of another Category I CPT code for OGM, this time for constitutional genetic disorders like developmental delay, intellectual disabilities and other disorders where it has been shown that OGM can outperform legacy cytogenomic methods, will be a further game-changer for clinical OGM testing," said Alka Chaubey, chief medical officer of Bionano. "OGM-Dx Postnatal Whole Genome SV and OGM-Dx Prenatal Whole Genome SV are used to detect all classes of structural variants that are traditionally tested by multiple methods such as karyotyping, chromosomal microarray analysis (CMA), 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 these assays and that establishing another Category I CPT code will raise the awareness and utility of OGM not only in the oncology community but now in the clinical genetic testing community as well."
About Bionano Laboratories:
Lineagen, Inc. d/b/a 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 or www.bionanolaboratories.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," "can," 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 Postnatal Whole Genome SV, OGM-Dx Prenatal Whole Genome SV and other OGM-based tests; the ability of the OGM-Dx Postnatal Whole Genome SV and OGM-Dx Prenatal Whole Genome SV tests to obtain coverage and reimbursement; whether the Category I CPT code will ultimately be important for clinical OGM testing; the ability of OGM to outperform legacy cytogenomic methods; 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 impact of adverse geopolitical and macroeconomic events, such as bank failures, the ongoing conflicts between Ukraine and Russia and in the Middle East and related sanctions, regional or global pandemics, uncertain market conditions, including tariffs and inflation, and supply chain disruptions on our business and the global economy; the failure of the Category I CPT code to drive use and adoption of the OGM-Dx Postnatal Whole Genome SV, OGM-Dx Prenatal Whole Genome SV and other OGM-based tests; the failure of the OGM-Dx Postnatal Whole Genome SV and OGM-Dx Prenatal Whole Genome SV tests to obtain coverage and reimbursement; the failure of the Category I CPT code to prove to be important for clinical OGM testing; the failure of OGM to outperform legacy cytogenomic methods; general market conditions; changes in our strategic and commercial plans; our ability to continue as a "going concern," which requires us to manage costs and obtain significant additional financing to fund our strategic plans and commercialization efforts; the risk that if we fail to obtain additional financing we may seek relief under applicable insolvency laws; and other risks and uncertainties including those described in our filings with the Securities and Exchange Commission ("SEC"), including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2024 and in other filings subsequently made by us with the SEC. 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, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
[email protected]
Investor Relations:
David Holmes
Gilmartin Group
+1 (858) 888-7625
[email protected]
