Publication Recommends OGM for Analysis of Hematological Neoplasms Due to Streamlined Structural Variant Detection and High Concordance with Traditional Cytogenetic Methods

Rhea-AI Summary

Bionano Genomics (Nasdaq: BNGO) released a validation study showcasing the effectiveness of optical genome mapping (OGM) compared to traditional cytogenetic methods in analyzing hematological neoplasms. The study involved 69 samples and revealed a 100% first-pass rate for OGM, with a sensitivity of 98.7%, specificity of 100%, and accuracy of 99.2%. OGM also identified additional structural variants, aiding better tumor classification and therapy selection. CEO Erik Holmlin expressed optimism about OGM’s potential as a primary cytogenomic test for hematologic malignancies.

Positive

• 100% first-pass rate in OGM study.
• Sensitivity of 98.7%, specificity of 100%, accuracy of 99.2%.
• Identified additional structural variants not detected by other methods.

Negative

• None.

SAN DIEGO, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the first published validation study to evaluate the performance of optical genome mapping (OGM) versus traditional cytogenetic techniques for the analysis of hematological neoplasms. According to the study, when compared to traditional cytogenetic methods, OGM showed robust technical and analytical performance, corrected misinterpretations and resolved balanced and unbalanced variants with high resolution in a single assay, streamlining the existing need to run multiple platforms.

Researchers analyzed samples from 69 individuals referred to a clinical lab for cytogenetic analysis to assess OGM as an approach to provide cytogenetic profiling in hematological neoplasms that included acute myeloid leukemia (AML), chronic myeloid leukemia (CML) and chronic lymphocytic leukemia (CLL). OGM’s technical performance resulted in a 100% first-pass rate, with concordance to traditional methods showing a sensitivity of 98.7%, a specificity of 100%, and an accuracy of 99.2%. OGM identified several additional structural variants (SVs) not detected by other methods, revealing the genomic architecture in these neoplasms that the study authors believe may provide an opportunity for better tumor classification, prognostication, risk-stratification, and therapy selection.

Erik Holmlin, PhD, president and chief executive officer of Bionano commented, “We are gratified to see study results showing how OGM may be useful in the analysis of hematological neoplasms. We believe that the study findings show OGM may alleviate the need for multiple technologies, and that it has potential to become a first tier cytogenomic test for hematologic malignancies.”

This publication can be found here: https://www.jmdjournal.org/article/S1525-1578(22)00290-2/fulltext

About Bionano Genomics

Bionano Genomics 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 OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. Through its BioDiscovery business, the Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. For more information, visit www.bionanogenomics.com, www.bionanolaboratories.com or www.biodiscovery.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,” “potential,” “may,” “believe” 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 utility of OGM to provide cytogenetic profiling in hematological neoplasms that included acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL). 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 the COVID-19 pandemic on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; failure of OGM to be adopted as a tool for cytogenetic profiling in hematological neoplasms that included acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL); future study results contradicting the results reported in the publication referenced above; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; 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, 2021 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.

CONTACTS
Company Contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
eholmlin@bionanogenomics.com

Investor Relations:
Amy Conrad
Juniper Point
+1 (858) 366-3243
amy@juniper-point.com

 

FAQ

What are the results of the Bionano Genomics validation study?

The validation study showed a 100% first-pass rate for OGM, with sensitivity at 98.7%, specificity at 100%, and accuracy at 99.2%.

How does OGM perform compared to traditional cytogenetic methods?

OGM demonstrated superior performance, correcting misinterpretations and identifying additional structural variants.

What implications does the OGM study have for hematological neoplasms?

The study indicates OGM may improve tumor classification, prognostication, risk-stratification, and therapy selection.

When was the validation study released by Bionano Genomics?

The validation study was announced on November 3, 2022.

What is the stock symbol for Bionano Genomics?

The stock symbol for Bionano Genomics is BNGO.