Klinefelter Syndrome

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/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

SALT LAKE CITY, Oct. 31, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced a license, development and supply agreement with to SPC Korea granting exclusive rights to market TLANDO® in South Korea. Under the terms of the distribution and license agreement, Lipocine will receive an upfront payment and is also eligible to receive certain regulatory and sales milestone payments, including a payment upon regulatory approval of TLANDO in South Korea. Lipocine is entitled to royalties on net commercial sales. Lipocine will supply TLANDO to SPC Korea and will receive a supply price. SPC Korea will assume responsibility for obtaining regulatory approval within the territory. "We are very pleased to partner TLANDO with SPC Korea," said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. "This license agreement represents a strategic opportunity to expand the global reach of TLANDO and to address the significant unmet medical need in South Korea. It underscores Lipocine's commitment to strategic partnerships that have the potential to drive growth and create value for our shareholders while advancing our goals to deliver innovative therapies to patients." About TLANDO TLANDO is approved by the US FDA as a testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). It was developed using Lipocine's proprietary Lip'ral drug delivery technology platform. For full prescribing information, please visit . About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in chronic weight management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for chronic weight management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit . Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product development efforts, our strategic plans for developing products, our ability to monetize product candidates, including through entering into partnering arrangements, our product candidates and related clinical trials, the achievement of milestones within and completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The early days of any foundational technology are characterized by overhype and skepticism. When the Internet first hit the scene in the 1990s, enthusiasts were awed by the potential to search for nearly anything online – even if nascent webpages weren’t entirely useful – and imagined opportunities for a more connected world. Skeptics saw the Internet as a fad that would never take over traditional means of communication or research. As time went on, there was a boom and a bust – but eventually, Internet applications turned from cool novelties to practical solutions to real problems. We’ve seen comparable cycles play out with mobile phones and social media. Today, we’re at a similar juncture for artificial intelligence (AI) in healthcare. When most people think about AI in healthcare, they envision futuristic applications like “AI doctors” helping to diagnose cancer and AI agents that automatically scan your body for cardiovascular events before they happen. While these innovations show the promise of AI for the future, most have yet to be deployed and validated at scale. If we want to find useful AI applications in healthcare today, we need to look further upstream to where it can be transformative in solving long-standing, complex problems. Clinical research is one such field that is ripe for AI’s impact. Today, data management remains a significant challenge, and clinical researchers rely on manual processes to organize and analyze mass amounts of health data. While in most areas of our lives we’re accustomed to typing queries into a search engine and receiving rapid answers, most clinical researchers are still stuck using spreadsheets to store, exchange, access, and analyze data. As the quantity and complexity of multimodal health data has grown with the rise of omics, the tools we used to use for analysis are not working. Outdated processes lead to research delays and stall innovation. presented by Health Tech The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani This is where AI comes in – not with hype, but with a real solution to clinical researchers’ data management woes. AI systems – particularly large language models (LLMs) – can help researchers organize data into ready-to-use formats and empower them to interact with their data more efficiently. Let’s dive a bit deeper into how these technologies are already enabling scientific breakthroughs in clinical research. One area where we’re seeing AI add value today is in accelerating data harmonization. In its source form, clinical data is very messy. Researchers typically spend months parsing through digital silos and disparate data formats to harmonize information into a common, research-ready structure. With the advent of LLMs, researchers can speed up this process by 100 times through AI-powered automation. LLMs harmonize mountains of data from registries, research databases, and electronic medical records (EMRs) into a controlled vocabulary that’s primed for analysis. Downstream, researchers can forgo time-consuming data wrangling and get straight to the science. Another high-value application is in extracting structured data from previously unusable “unstructured” data, such as the free-text notes from an EMR. Because this information – which includes important details on a patient’s medication usage, for example – isn’t organized into a structured format, it’s often excluded from research databases. LLMs can map this text from clinical notes to more structured fields, answering questions like “did this patient receive radiotherapy” or “did this person have a cancer recurrence.” This works with images as well. For example, we use AI-powered computer vision to extract metadata from histopathology images like cell counts, cell types, staining, and more. Once it’s structured, all of this data can then be made available for research – accelerating the time to insight. presented by Health IT Accelerating Claim Processing: Strategies to Shorten the Life of a Claim These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. By Greenway Health AI-powered user interfaces are also radically improving the accessibility of data, creating a new paradigm for interactions between researchers and datasets. Rather than needing to learn the technical intricacies of databases – or working with data specialists who know how to write code – AI-powered interfaces allow researchers to “chat with data” using natural language. Rather than writing a line of code, researchers can simply type, “Find me all patients that have had breast cancer of pathological stage II or higher and that have pathogenic variants on the genes associated with Lynch’s Syndrome,” into the AI-powered user interface. The LLM understands the request and converts it into a query on the harmonized dataset, returning an answer in seconds instead of weeks. Not only does this accelerate time to insight, it democratizes access to data, opening the door for even more medical experts to get involved in research – especially those without coding expertise. I believe hype and skepticism are both good when it comes to AI. These points of view will push the boundaries of what’s possible while reeling in the less effective use cases. But it’s important that we focus attention on the areas where AI is already having a significant impact. These are the practical applications that will allow the best and brightest researchers to focus on science rather than data munging. Let’s get to work on those.