Bionano Laboratories Announces Expansion of Diagnostic Testing Based on Optical Genome Mapping for Hematologic Malignancies

SAN DIEGO, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics, Inc. (Nasdaq: BNGO) that offers CLIA-certified laboratory developed test (LDTs), today announced expansion of optical genome mapping (OGM) based testing of hematologic malignancies at Memorial Sloan Kettering Cancer Center (MSK), following approval from the New York State Department of Health (NYSDOH).

Hematologic cancers, including acute leukemias, myelodysplastic syndromes (MDS), plasma cell neoplasms (PCN), and lymphoid malignancies, frequently harbor complex genomic rearrangements that can be challenging to fully characterize using traditional cytogenetic methods. Numerous publications have shown evidence supporting the use of OGM to detect these variants and MSK is the first center in New York to offer OGM-based testing for a broad patient population with suspected hematologic malignancies.

Key highlights include:

• Independent validation from academic medicine: MSK’s OGM-based LDTs for hematologic malignancies after receiving approval from the New York State Department of Health (NYSDOH), adds to a growing body of independent clinical adoption that reinforces the evidence base supporting OGM in this setting.
• More comprehensive genomic assessment: OGM enables genome-wide detection of structural variants and copy number alterations in a single workflow, offering a more complete view of disease-relevant genomic complexity than conventional cytogenetic methods used individually.
  
  

Dr. Yanming Zhang of Memorial Sloan Kettering Cancer Center said, "Hematologic malignancies often contain complex chromosomal abnormalities that require sophisticated approaches to detect and interpret. Our clinical laboratory has implemented optical genome mapping as an additional method for genomic characterization of these abnormalities.”

"MSK's launch of OGM-based testing is a powerful validation of this technique's role in modern cancer diagnostics and provides support for our own current and future OGM-based tests," said Alex Hastie, PhD, Chief Scientific Officer of Bionano and responsible for overseeing test development at Bionano Laboratories. "When one of the world's leading cancer centers adopts OGM for hematologic malignancy testing, it reflects the strength of the clinical evidence behind it."

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 Genomics
Bionano is a provider of genome analysis solutions that 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. Bionano offers OGM solutions for applications across basic, translational, and clinical research, as well as an industry-leading, platform-agnostic genome analysis software solution and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services. For more information, visit www.bionano.com

Bionano's products are for research use only and not for use in diagnostic procedures.

Forward-Looking Statements of Bionano Genomics
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There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to: our ability to improve our margins, extend our cash runway and reach a potential pathway to profitability; our ability to continue as a going concern as disclosed in our filings with the SEC, which requires us to manage costs and obtain significant additional financing to fund our strategic plans and commercialization efforts; our ability to execute on our strategy and achieve our objectives; the impact and utility of our cost savings initiative and our recent financing; our ability to continue to drive OGM (as defined above) adoption by potential customers for routine use in genomic analysis; the impact, or lack thereof, of Category I CPT codes to accelerate or increase the adoption of OGM; continued research, presentations and publications involving OGM and its utility compared to traditional cytogenetics and our technologies; the impact of our Stratys™ system and VIA™ software to increase throughput and simplify analysis of OGM data; our ability to drive adoption of OGM and our technology solutions; our ability to further deploy new products and applications for our technology platforms; our expectations and beliefs regarding future growth of the business and the markets in which we operate; our ability to consummate any strategic alternatives including the risk that if we fail to obtain additional financing we may seek relief under applicable insolvency laws; the size and growth potential of the markets for our products, and our ability to serve those markets; the rate and degree of market acceptance of our products; our ability to manage the growth of our business and integrate acquired businesses; the fact that we are limited to “research use only” with respect to many of the materials and components used in our consumable products including our assays; our ability to expand our commercial organization to address effectively existing and new markets that we intend to target; the impact from future regulatory, judicial, and legislative changes or developments in the U.S. and foreign countries; our ability to compete effectively in a competitive industry; the introduction of competitive technologies or improvements in existing technologies and the success of any such technologies; the performance of our third-party contract sales organizations, suppliers and manufacturers; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, reimbursement rates, capital requirements and needs for additional financing; the impact of adverse geopolitical and macroeconomic developments, such as recent and future bank failures, ongoing international conflicts, and related sanctions, regional or global pandemics, inflation, tariffs, increased cost of goods, supply chain issues, and global financial market conditions; on our business and operations, as well as the business or operations of our suppliers, customers, manufacturers, research partners and other third parties with whom we conduct business and our expectations with respect to the duration of such impacts and the resulting effects on our business; our ability to realize the anticipated benefits and synergies of our prior and any future acquisitions or other strategic transactions; our ability to attract collaborators and strategic partnerships; 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 (“SEC”), including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2025, any subsequently filed Quarterly Reports on Form 10-Q and in other filings subsequently made by us with the SEC. 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CONTACTS

Company Contact:
Al Luderer, Chairman & Interim CEO
Bionano Genomics, Inc.
+1 (781) 507-4438
Aluderer@bionano.com

Investor Relations:
Webb Campbell
Gilmartin Group
+1 (415) 520-5817