SAN DIEGO, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Bionano Laboratories today announced the publication of a study covering the analytical validation of its laboratory developed test (LDT), marketed as OGM-Dx™ HemeOne. This LDT is based on optical genome mapping (OGM) analysis of blood or bone marrow samples to detect structural variants (SVs) of diagnostic and prognostic utility in individuals with a new or an existing diagnosis of a hematological malignancy. The publication also included a multi-site peer-reviewed IRB-approved analytical validation study of OGM for the analysis of hematological malignancy samples, conducted by researchers at laboratories including Bionano Laboratories, Augusta University, University of Rochester Medical Center, and Children’s Hospital Los Angeles.

In the study, researchers collaboratively defined a workflow for the analysis of hematological malignancies using OGM, and established protocols for analysis and interpretation using guidelines-based targeted variant assessment, in addition to a whole-genome analysis. The OGM-Dx HemeOne LDT was then validated at one site for concordance, sensitivity, specificity, lower limit of detection, increased diagnostic yield, and assay robustness, using samples from 60 cases with hematological malignancies (with various disease subtypes), 2 cancer cell lines, and 18 controls, generating a total of 215 datasets. Subsequently, the OGM workflow was applied at the other three sites, showing high levels of reproducibility across the sites.

The study authors found that OGM is a viable alternative to traditional cytogenetic methods, such as KT, FISH, and CMA, due to its ability to detect all classes of SVs, with the highest resolution of any cytogenetic method in clinical research use, and to improve diagnostic yield. The authors also noted OGM’s simple and efficient end-to-end workflow, which may offer researchers streamlined analysis and lab adoption.

Key findings of the analytical validation of the LDT:

• The OGM-Dx HemeOne LDT demonstrated 100% concordance with traditional methods in the detection of SVs and 100% concordance in the detection of more complicated aberrations, such as translocations and inversions, at or above a 5% variant allele fraction (VAF) threshold
• The OGM-Dx HemeOne LDT was 100% specific and 100% sensitive for the detection of the set of Tier 1 and Tier 2 variants, as defined by World Health Organization (WHO) and National Comprehensive Cancer Network (NCCN) guidelines for comprehensive evaluation of hematologic malignancies
• The OGM-Dx HemeOne LDT resolved structures in complex genomes, effectively consolidating the results of three orthogonal technologies (KT, FISH and CMA)
• In 28% of cases (17 out of 60), OGM identified additional pathogenic variants not previously reported by traditional methods

Finally, as part of the multi-site analytical study of OGM performance,14 cases and 10 controls were run and analyzed using the same OGM workflow at three outside laboratories. The results of this evaluation showed reproducible concordant performance of 96.4% across all sites, operators, and samples.

“We are pleased to see the clinical validation of Bionano Laboratories' OGM-Dx™ HemeOne LDT, analyzing its potential to serve as a first-tier cytogenetic test for heme malignancies. We believe that our LDT can provide a comprehensive evaluation of genome wide SVs that will allow oncologists to assess the best potential therapies for their malignancy patients,” stated Justin Leighton, vice president of laboratory business at Bionano Laboratories. “The study authors also noted that OGM can be easily implemented in the clinical setting and can substantially reduce operational complexity and improve the detection rate of pathogenic SVs and may provide a reproducible and robust alternative to traditional cytogenetic methods in routine workup of most hematological malignancies.”

The publication can be viewed here.

About Bionano Laboratories:

Bionano Laboratories provides access to genetic answers and support utilizing cutting-edge technologies to advance the way you see the genome.  Our 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

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,” “may,” “potential,” “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 OGM-Dx™ HemeOne LDT for the diagnostic and prognostic utility in individuals with a new or an existing diagnosis of a hematological malignancy; the ability and utility of the OGM-Dx HemeOne LDT to allow oncologists to assess the best potential therapies for their malignancy patients; the ability of the OGM-Dx HemeOne LDT to detect structural variants (SVs) as compared to traditional cytogenetic techniques; the ability of OGM to be easily implemented in clinical settings; and the ability of OGM-based LDTs to remove barriers for OGM adoption in clinical and research settings. 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 adverse geopolitical and macroeconomic events, such as recent and potential future bank failures, potential global pandemics and the ongoing conflicts between Ukraine and Russia and Israel and Hamas, on our business and the global economy; general market conditions; the failure of the OGM-Dx HemeOne to prove useful for the diagnostic and prognostic utility in individuals with a new or an existing diagnosis of a hematological malignancy; the failure of the OGM-Dx HemeOne LDT to detect SVs as compared to traditional cytogenetic techniques; the failure of the OGM-Dx HemeOne LDT to allow oncologists to assess the best potential therapies for their malignancy patients; the failure of OGM to be easily implemented in clinical settings; the failure of OGM-based LDTs to remove barriers for OGM adoption in clinical and research settings; the ability of the OGM workflow to offer the anticipated benefits for and contributions to the areas reported in the study results referenced in this press release; future study results contradicting the study results reported in the publication referenced in this press release; 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 the ability of our parent corporation, Bionano Genomics, Inc., to continue as a “going concern”; the ability of medical and research institutions to obtain funding to support adoption or continued use of our services and technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in the filings of our parent corporation, Bionano Genomics, Inc., with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2022 and in other filings subsequently made by them 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.

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