CD138

SAN DIEGO, May 02, 2025 (GLOBE NEWSWIRE) -- Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics, Inc. (Nasdaq: BNGO) that offers CLIA-certified laboratory developed tests (LDTs) based on optical genome mapping (OGM), today announced the publication in the American Journal of Hematology of expert recommendations from the International Consortium for Optical Genome Mapping (ICOGM) for the integration of OGM as a standard-of-care (SOC) cytogenetic assay for diagnostic workflows in various clinical settings. Nineteen (19) experts from the ICOGM, representing relevant multidisciplinary fields, conducted an in-depth review of the classification of hematolymphoid malignancies using the World Health Organization (WHO, 5th ed.) and ICC (International Consensus Classification) criteria and published studies of OGM performance to assess whether OGM could provide a comprehensive analysis of the genome sufficient for better diagnosis, prognosis and treatment compared to existing SOC workflows across several indications. Based on the assessment, the ICOGM developed a set of expert recommendations for OGM (A) as a first-line test in place of karyotyping, fluorescent in situ hybridization (FISH) and chromosomal microarray analysis (CMA) in some clinical settings; or (B) as an alternative to the traditional methods in other clinical settings when these traditional methods are insufficient. Summary of Key Recommendations for Clinical Use of OGM: A. OGM is recommended as a first-line test for AML, MDS, MPN, B-ALL, T-ALL, pediatric leukemias and unexplained eosinophilia and myeloid/lymphoid neoplasms with eosinophilia:OGM is recommended as a first-line cytogenetic tool in place of conventional karyotyping and FISH (except for rapid PML::RARA detection in APL) when high-resolution genome-wide structural variation (SV) detection is required. OGM allows for the identification of cryptic fusions of genes for which targeted therapy may be available (e.g. KMT2A, MECOM, NUP98)OGM avoids the need for large FISH panels or multiple orthogonal assaysOGM’s unbiased detection improves risk stratification and guides targeted therapy B. OGM is recommended as an alternative to karyotyping/FISH/CMA for CLL, Plasma cell neoplasms/Multiple Myeloma, aplastic anemia, bone marrow failure syndromes and germline predisposition syndrome: Conventional karyotyping fails or yields no metaphasesFISH/CMA do not detect known abnormalities despite clinical suspicionComplex or ambiguous chromosomal abnormalities need resolutionLow-frequency or rare hematologic malignancies require cost-effective broad analysisAdditional structural variant data may impact diagnostic clarity or therapy decisionsFor CLL/SLL; OGM as a viable alternative to FISH and CMA, except for low-level TP53 deletions.For plasma cell disorders, OGM is recommended to be effective when used with CD138 enrichment "We believe this publication is a landmark for the global clinical cytogenomics community. The consensus from a global panel of experts confirms that OGM-based assays, like the LDTs we offer at Bionano Laboratories, can replace or be used to augment tests based on traditional methods. The drivers behind these recommendations are the ability of our OGM LDTs to yield higher diagnostic clarity within a simplified laboratory workflow that is more cost effective with a faster turnaround time. These expert recommendations establish that OGM-based LDTs are aligned with the latest diagnostic (WHO5, ICC) and prognostic (comprehensive cytogenetic scoring system (CCS), revised international prognostic scoring system (IPSS-R) and molecular international prognostic scoring system (IPSS-M)) classification systems for hematologic malignancies. It’s a win for our laboratory, for clinicians and, more importantly, for patients," commented Dr Alka Chaubey, PhD, FACMG, chief medical officer of Bionano. For more information or to read the full publication, visit: https://doi-org.libproxy1.nus.edu.sg/10.1002/ajh.27688 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 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 optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services. For more information, visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.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 “ability,” “believe,” “can,” “could,” “may,” 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 be an alternative to traditional cytogenomic methods as described in the publication referenced in this press release; the ability and utility of OGM to become a SOC cytogenetic assay for diagnostic workflows in various clinical settings as described in the publication referenced in this publication; and the ability of OGM to be implemented in clinical 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 impact of adverse geopolitical and macroeconomic events, such as bank failures, the ongoing conflicts between Ukraine and Russia and in the Middle East and related sanctions, regional or global pandemics, uncertain market conditions, including tariffs and inflation, and supply chain disruptions on our business and the global economy; the failure of OGM to be an alternative to traditional cytogenomic methods as described in the publication referenced in this press release; the failure of OGM to become a SOC cytogenetic assay for diagnostic workflows in various clinical settings as described in the publication referenced in this publication; the failure of OGM to be implemented in clinical settings; the ability of the OGM workflow to offer the anticipated benefits for and contributions to the areas reported in the publication referenced in this press release; future recommendations contradicting the recommendations reported in the publication referenced in this press release; general market conditions; . 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, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionano.com Investor Relations:David HolmesGilmartin Group+1 (858) 888-7625IR@bionano.com

SAN DIEGO, April 08, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a study published in The Journal of Molecular Diagnostics that describes a method for analysis of multiple myeloma (MM) by optical genome mapping (OGM). MM is one of the most common blood cancers, or hematologic malignancies, and is understood to be a difficult sample to analyze using traditional cytogenetics. Direct analysis of MM samples, by methods such as FISH or OGM, can be problematic because it is challenging to isolate enough cells with a known MM marker (CD138) on their surface, so-called CD138-positive cells. In this paper, researchers at Institute of Medical Genetics, Lille University Hospital, Lille, France, have described a method for OGM that can overcome the hurdle of limited sample quantity and can cut in half the effective CD138-positive cell requirement for analysis by OGM. Key Findings and Takeaways Mixing CD138-positive with CD138-negative cells from the same sample at a ratio of 1:1 can be sufficient to perform OGM. Since OGM typically requires 1 million cells, this finding suggests that as few as 0.5 million of the CD138-positive cells are sufficientOGM reveals More Genetic Events: Achieving 93% (13/15) concordance with FISH, the current standard, OGM also uncovered more than 22 additional genetic variants that were previously undetected by FISHOGM Streamlines the Analysis: Consolidating multiple assessments (KT and multiple FISH assays) into a single, comprehensive approach using OGM can be more efficient and maximize the value of scarce cell samples while simplifying laboratory workflows and reducing the need for separate, time-consuming testsOGM Improves Prognostic Risk Evaluation: By capturing both primary and novel potentially pathogenic variants, OGM provides a comprehensive genomic profile that can be used to support more precise prognostic risk stratification “Multiple myeloma is one of the most requested cancer types by customers seeking to implement OGM in routine use. We believe this publication marks an important advancement for OGM research in hematologic malignancies. The senior author, Dr Daudignon, has been among the pioneers spearheading the adoption of OGM in France through the French Optical Genome Mapping Group (FrOGG) and has included OGM as an alternative to legacy cytogenetic methods on behalf of the Groupe Francophone de Cytogénétique Hématologique (GFCH) for the evaluation of MM. This simple approach to OGM analysis of MM can offer the opportunity for researchers to expand their OGM menus to include a prevalent blood cancer with a significant unmet medical need,” commented Erik Holmlin, PhD, president and chief executive officer of Bionano. The full research publication is available at: https://www.jmdjournal.org/article/S1525-1578(25)00035-2/fulltext 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 optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services. For more information, visit www.bionano.com or www.bionanolaboratories.com. Bionano’s products are for research use only and not for use in diagnostic procedures. 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” 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 describe future expectations, plans, results, or strategies, among other things, and in this release include, but are not limited to, statements regarding OGM’s ability to produce concordant results with FISH and other traditional cytogenetic methods for analyzing MM samples; the ability of OGM to identify new genetic variants for MM not identified with traditional cytogenetic methods; the ability of OGM to be more efficient than traditional cytogenetic methods; the ability to achieve results similar to those referenced in this press release using the methods described therein; the importance of the publication referenced in this press release to prove to be an important advancement in MM research; the ability and utility of the method described in this press release to further open researchers’ ability to expand their OGM menu; and other statements that are not historical fact. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. 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 impact of adverse geopolitical and macroeconomic events, such as recent and future bank failures, the ongoing conflicts between Ukraine and Russia and in the Middle East and related sanctions and any regional or global pandemics, on our business and the global economy; the failure of OGM to produce concordant results with FISH and other traditional cytogenetic methods for analyzing MM samples; the failure of OGM to identify new genetic variants for MM not identified with traditional cytogenetic methods; the failure of OGM to be more efficient than traditional cytogenetic methods; the inability to achieve results similar to those referenced in this press release using the methods described therein; the failure of the publication referenced in this press release to prove to be an important advancement in MM research; the failure of the method described in this press release to further open researchers’ ability to expand their OGM menu; future publications that contradict the findings of the publication referenced in this press release; the failure of our ability to drive adoption and utilization of optical genome mapping as a replacement to traditional cytogenetic techniques; challenges inherent in developing, manufacturing and commercializing products; 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; changes in our strategic and commercial plans; our ability to continue as a “going concern,” which requires us to manage costs and obtain significant additional financing to fund our strategic plans and commercialization efforts; our ability to consummate any strategic alternatives; the risk that if we fail to obtain additional financing we may seek relief under applicable insolvency laws; and other risks and uncertainties including those 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, 2024 and in other filings subsequently made by us with the SEC. All forward-looking statements contained in this report 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 are under no duty to update any of these forward-looking statements after the date they are made to conform these statements to actual results or revised expectations, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date the statements are made. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements contained in this press release. CONTACTSCompany Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionano.com Investor Relations:David HolmesGilmartin Group+1 (858) 888-7625IR@bionano.com

LOS ANGELES, Nov. 8, 2024 /PRNewswire/ -- Nammi Therapeutics, Inc. (Nammi), a clinical stage immuno-oncology company with a diverse pipeline created with the Masked-Immunocytokine (MIC) and Nammisome platforms, announces dosing of the first patient in the first in human Phase 1 trial (NCT06582017). The Phase 1 study is a two-part, open-label multi-center study that is expected to enroll approximately 100 patients with advanced CD138-expressing cancers. Part A of the study will evaluate the safety and tolerability of escalating doses of QXL138AM, with secondary endpoints assessing pharmacokinetics and immunogenicity. Part B of the study will involve dose expansion in three cohorts (two solid tumor indications with high CD138 prevalence and multiple myeloma) with primary endpoints focused on safety and tolerability and secondary endpoints assessing anti-tumor activity. The Company will conduct the Phase 1 study at investigator sites across the United States. While the two solid tumor indications for expansion have not yet been determined, QXL138AM has been granted Orphan Drug Designation in Pancreatic Cancer. Other factors, including prevalence of CD138 expression, preclinical efficacy, previous reports on clinical efficacy with approved Interferon alfa therapeutics, the extent of unmet need, and Nammi's clinical experience in Part A will also be used to determine the solid tumor indications for expansion. "Interferon alpha 2 is a potent anti-cancer therapeutic, but its clinical benefit is limited by significant toxicity when administered systematically. QXL138AM utilizes Nammi's masked immunocytokine technology, whereby the interferon alpha 2 is masked and fused to a tumor-targeting antibody. The antibody anchors QXL138AM on the surface of tumor cells where proteases can remove the mask thereby activating the Interferon alpha 2, facilitating a wider therapeutic window," said Dr. Dennis Kim, M.D., chief medical officer for the study. "We're very excited to have dosed the first patient with QXL138AM here at START," stated Dr. Drew W. Rasco, Associate Director at The START Center for Cancer Research in San Antonio, TX. "We believe that there is significant potential with Nammi's immunocytokine technology in the treatment of multiple cancer types, and we look forward to working with the Nammi team to develop this new therapy over the coming years." About Nammi Therapeutics, Inc. Nammi Therapeutics, Inc. is an immuno-oncology company based in Los Angeles that is developing platforms and products that selectively activate anti-tumor immunity within the tumor microenvironment while minimizing systemic activation. By reducing systemic activation of the immune system, Nammi expects to improve safety and enhance the ability to combine multiple immune modulators. In addition to the MIC platform, Nammi has also developed a nanoparticle platform to deliver Immune Modulating Prodrugs (IMPs) using their Nammisome technology. Multiple Nammisome clinical candidates have also been selected for development. For further information, visit or email [email protected]. SOURCE Nammi Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED