Bionano Laboratories Announces Publication of the Analytical Validation of its OGM-Based Laboratory Developed Test for Hematological Malignancies and Additional Multi-Site Technical Evaluation of OGM
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
The publication can be viewed here.
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Forward-Looking Statements of
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
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