Bionano Announces Publication of a Breast Cancer Study Showing that the Number of SVs Detected with OGM May Be Related to Prognosis, Tumor Progression and Chemotherapy Resistance

Rhea-AI Summary

Bionano Genomics, Inc. (BNGO) announced a study on optical genome mapping in hereditary breast and ovarian cancer, revealing correlations between structural variations, mutated genes, and poor prognosis. OGM detected chromothripsis events and novel gene fusions accurately, potentially aiding in therapy decisions. The study sheds light on the impact of SV heterogeneity in HBOC-related cancers.

Insights

Medical Research Analyst

The study published by Bionano Genomics on optical genome mapping (OGM) in hereditary breast and ovarian cancer (HBOC) syndrome presents significant insights into the relationship between structural variations (SVs) and cancer prognosis. From a medical research perspective, the ability of OGM to detect chromothripsis events and novel gene fusions—some of which were previously undetected—marks a notable advancement in genomic technologies. This could potentially lead to the development of more targeted therapies and diagnostic tools, thereby influencing the biotech sector's approach to precision medicine.

Understanding the SVs in cancer cells is important for developing personalized treatment plans. The categorization of breast cancer samples into SVhigh and SVlow groups based on OGM results illustrates a potential method for stratifying patients, which may inform treatment decisions. The higher Ki-67 expression and homologous recombination deficiency (HRD) scores in SVhigh samples suggest that these biomarkers could be integrated into clinical practice to predict treatment outcomes. However, the clinical application of these findings will require validation in larger, diverse populations and the development of standardized OGM protocols.

Oncology Doctor

As an oncologist, the implications of Bionano Genomics' study for patient care are substantial. The ability to detect SVs and their correlation with disease severity could enhance our prognostic models for hereditary breast and ovarian cancer syndrome. The detection of novel gene fusions, which may play a role in drug resistance, is particularly intriguing as it opens the door for new therapeutic targets. It's important to note that while OGM appears promising, its integration into clinical settings will require careful consideration of cost-effectiveness, scalability and the establishment of clear guidelines for interpretation and actionability of the results.

The study's findings could also influence the design of future clinical trials, focusing on patients with high SVs and altered signaling pathways. This precision approach could lead to more effective trial outcomes and expedited drug development. Nonetheless, the transition from research to clinical practice involves numerous regulatory and logistical hurdles that must be navigated before patients can benefit from these discoveries.

Financial Analyst

In terms of business impact, Bionano Genomics' publication on the use of OGM in detecting structural variations in HBOC syndrome could have meaningful implications for the company's market position. The ability to identify novel gene fusions and SVs positions Bionano as a potential leader in the genomic analysis market. This technological edge could attract partnerships with pharmaceutical companies interested in developing new cancer therapies, potentially leading to increased revenue streams.

Investors should monitor Bionano's progress in translating these research findings into commercially viable products or services. The company's capacity to secure patents for its unique detection methods could provide a competitive advantage. However, investors should also consider the time and capital required to achieve regulatory approvals and widespread clinical adoption. The long-term financial impact will depend on the company's success in overcoming these challenges and establishing OGM as a standard practice in cancer diagnostics.

SAN DIEGO, March 19, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the publication of a study of optical genome mapping (OGM) in hereditary breast and ovarian cancer (HBOC) syndrome showing that when tumors exhibited higher overall numbers of structural variations (SVs) they tended to have more mutated genes and altered signaling pathways, which may correlate with poor prognosis, tumor progression and chemotherapy resistance. Researchers also found that OGM was able to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods.

HBOC syndrome is estimated to cause 5-10% of all breast cancers and is commonly characterized by harmful germline mutations in the BRCA1 or BRCA2 genes. Due to limitations inherent in common methods of genome analysis, researchers have limited knowledge regarding the potential impact of structural abnormalities and SV heterogeneity in HBOC-related cancers. The study authors selected OGM for this analysis due to its ability to detect multiple classes of SVs with genome-wide coverage, high resolution and accuracy.

Study authors categorized the HBOC-related breast cancer samples into two groups, SV^high and SV^low, based on the number of SVs detected by OGM, high or low Ki-67 expression, and the number of mutated genes and altered signaling pathways. The authors noted that SV^high samples were associated with higher Ki-67 expression and higher homologous recombination deficiency (HRD) scores, indicating that genetic alterations may have potential predictive and therapeutic significance. The SV^high samples also showed higher numbers of chromothripsis events and novel gene fusions than the SV^low samples. Eight novel gene fusions were identified by OGM, including three that had not previously been detected by other methods of analysis. These gene fusions may be involved in drug resistance and tumor development.

“We are pleased to see the publication of this study, which highlights OGM as a promising tool for detecting novel variants in HBOC-related breast cancer that have oncogenic potential. We believe the comprehensive assessment of the role SVs play in breast cancers with abnormal DNA repair functions might expand our current understanding of disease progression and precision medicine in breast cancer," commented Erik Holmlin, PhD, president and chief executive officer of Bionano.

The paper is available at: https://www.imrpress.com/journal/FBL/29/1/10.31083/j.fbl2901002/htm

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 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. 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. The Company additionally offers nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. For more information, visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.com.

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

Forward-Looking Statements of Bionano

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “may,” “potential” 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 OGM to detect SVs in samples suspected of HBOC syndrome; and the ability and utility of OGM to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods. 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 geopolitical and macroeconomic developments, such as recent and potential future bank failures, supply chain disruptions, global pandemics, inflation 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 OGM to detect SVs in samples suspected of HBOC syndrome; the failure of OGM to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods; study results that differ or contradict the results reported in the study referenced in this press release; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our need and ability to obtain sufficient financing to fund our strategic plans and commercialization efforts, our ability to effectively manage our uses of cash, and our ability to continue as a “going concern”; 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, 2023 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@bionano.com

Investor Relations:
David Holmes
Gilmartin Group
+1 (858) 888-7625
IR@bionano.com

FAQ

What did Bionano Genomics announce regarding a study on hereditary breast and ovarian cancer?

Bionano Genomics announced a study on optical genome mapping in hereditary breast and ovarian cancer, focusing on the correlation between structural variations, mutated genes, and poor prognosis.

What is the significance of optical genome mapping (OGM) in the study?

OGM was able to accurately detect chromothripsis events and novel gene fusions in cancer tissues, including those not detected by other methods, potentially aiding in therapy decisions.

What is the estimated percentage of breast cancers caused by HBOC syndrome?

HBOC syndrome is estimated to cause 5-10% of all breast cancers.

Why was OGM selected for the analysis in the study?

OGM was selected for its ability to detect multiple classes of structural variations with genome-wide coverage, high resolution, and accuracy.

What were the key findings regarding SVhigh and SVlow breast cancer samples in the study?

SVhigh samples showed higher Ki-67 expression, higher homologous recombination deficiency scores, more chromothripsis events, and novel gene fusions compared to SVlow samples.