Smoldering Multiple Myeloma

MONDAY, Sept. 23, 2024 -- The risk for severe maternal morbidity (SMM) and adverse pregnancy outcomes is increased for gestational carriers, or pregnancy surrogates, compared with women conceiving naturally or via in vitro fertilization (IVF), according to a study published online Sept. 24 in the Annals of Internal Medicine . Maria P. Velez, M.D., Ph.D., from Queen's University Kingston in Ontario, Canada, and colleagues conducted a population-based cohort study to examine the risk for SMM and severe neonatal morbidity (SNM) in gestational carriers. Of the eligible singleton births, 846,124, 16,087, and 806 (97.6, 1.8, and 0.1 percent, respectively), were via unassisted conception, IVF, and gestational carriage, respectively. The researchers found that the risks for SMM were 2.3, 4.3, and 7.8 percent for unassisted conception, IVF, and gestational carriage, respectively. The weighted relative risks were 3.30 and 1.86, respectively, comparing gestational carriage with unassisted conception and IVF. For SNM, the respective risks were 5.9, 8.9, and 6.6 percent; the weighted relative risks were not significantly increased for gestational carriage versus unassisted conception or IVF. Comparing gestational carriers with either comparison group, hypertensive disorder, postpartum hemorrhage, and preterm birth at less than 37 weeks were also significantly higher. "Given the increasing use of gestational carriers, and the potentially higher risk for SMM and other adverse pregnancy outcomes, a judicious selection of these carriers may be warranted -- something recommended within clinical practice guidelines," the authors write.

Toronto, Ontario--(News - June 18, 2024) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the "Company" or "Telo") a biotech company developing the industry's leading telomere technology platform with diagnostic and prognostic applications measuring genomic instability in oncology, is pleased to announce that the College of American Pathologists (CAP) has recently accepted Telo Genomics' submission to add Telo's test for smoldering multiple myeloma (SMM), TeloViewSMM, as a Laboratory Developed Test (LDT) on Telo's-CAP approved menu of clinical tests. The TeloViewSMM test addresses a critical unmet need in the management of SMM patients. The test is capable of identifying SMM patients with the highest risk of progression to full stage multiple myeloma disease, an incurable deadly blood cancer. These patients will benefit from immediate treatment intervention. More importantly, the TeloViewSMM test can also confirm disease stability in low risk SMM patients. These patients can be monitored over time using the TeloViewSMM test without being exposed to unnecessary and uncomfortable expensive treatment. The validation of TeloViewSMM as a clinical test, was conducted in collaboration with both the Mayo Clinic and the Dana Farber Cancer Institute, and showed superior sensitivity (accuracy in identifying high risk patients) of 83% and specificity (accuracy in identifying stable patients) of 76%. The validation was recently published by the American Journal of Hematology (AJH). The article is now available online on the Journal website at . Recognized for its rigorous and robust standards, and as one of the world's most prestigious certifying bodies - CAP is mandated to elevate quality and mitigate risk in diagnostic tests to assure improved patient outcomes. Based on the inclusion of the TeloViewSMM test in CAP approved Telo's testing menu, the test can now be offered to hospitals, cancer centers and clinics in the US. CAP has granted TeloViewSMM an accelerated approval waiving the onsite assessment, reflecting and confirming the excellence that Telo has demonstrated during the previous CAP onsite assessment that took place in March 2024. "Adding the TeloViewSMM to Telo's CAP approved tests menu is the official inauguration of this critical prognostic solution for smoldering myeloma patients as a clinical test," said Sherif Louis, Telo's President & CTO. "We capitalize on developing value added prognostic tests to offer high quality actionable solutions for clinical unmet needs, such as risk-stratifying patients with smoldering multiple myeloma. We look forward to enriching the management of myeloma disease with our MRD tests to monitor post treated patients and accurately identify those with highest risk of relapse prior to the relapse event." About the College of American Pathologists As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The CAP has over 23,000 laboratory participants, in addition to accreditation, the CAP offers proficiency testing/external quality assessment (PT/EQA) programs, quality improvement tools, and protocols and guidelines to ensure excellence in all areas across the laboratory. Built on a foundation of pathologist expertise, the College of American Pathologists (CAP) partners with laboratories worldwide to elevate the quality of laboratory medicine with best-in-class solutions designed to drive operational excellence, achieve diagnostic confidence, and ensure the best patient care. For more information on CAP, please visit the CAP Newsroom, CAP.org and yourpathologist.org to see how pathologists work and observe the stories of the patients who trust them with their care. About Lab Developed Tests Lab-developed tests are a type of in vitro diagnostic (IVD) tests, which test samples of blood, saliva, or tissue to diagnose and monitor for diseases and conditions. LDT is the most common regulatory format to introduce new innovative clinical diagnostics tests. Like other IVDs, LDTs are intended to be conducted in a professional setting by licensed providers. Many IVDs are designed by one manufacturer and offered by many different laboratories (e.g., a machine to measure blood counts sold to many facilities), but LDTs are different from these other IVDs because they are designed, manufactured, and offered by a single laboratory. About TELO Telo Genomics Corp. is a biotech company pioneering the most comprehensive telomere platform in the industry with powerful applications and prognostic solutions. These include liquid biopsies and related technologies in oncology and neurological diseases. Liquid biopsy is a rapidly growing field of significant interest to the medical community for being less invasive and more easily replicated than traditional diagnostic approaches. By combining our team's considerable expertise in quantitative analysis of 3D telomeres with molecular biology and artificial intelligence to recognize disease associated genetic instability, TELO is developing simple and accurate products that improve day-to-day care for patients by serving the needs of pathologists, clinicians, academic researchers and drug developers. The benefits of our proprietary technology have been substantiated in 160+ peer reviewed publications and in 30+ clinical studies involving more than 3,000 patients with multiple cancers and Alzheimer's disease. Our lead application, TELO-MM is being developed to provide important, actionable information to medical professionals in the treatment of multiple myeloma, a deadly form of blood cancer. For more information please visit . For further information, please contact: Sherif Louis, President & CTO sherif.louis@telodx.com Telo Genomics 416-673-8487 Neither the TSX Venture Exchange nor its Regulation Services Provider (as such term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Cautionary Note Regarding Forward-Looking Statements Certain information contained herein may constitute "forward-looking information" under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as "intends", "will", or variations of such words and phrases or statements that certain actions, events or results "will" occur. Forward-Looking statements regarding the clinical efficacy of products, commercial viability of products, use of proceeds, and the ability of the TeloView® platform to deliver personalized medicine resulting in better treatments and outcomes are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws. To view the source version of this press release, please visit

Toronto, Ontario--(News - June 12, 2024) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (FSE: 3D0A) ("Telo" or the "Company"), is pleased to announce that results of the development, validation and implementation of its machine learning and Artificial Intelligence (AI) modules, used in its TeloView myeloma diagnostic tests, were presented at the American Society of Clinical Oncology (ASCO) 2024 annual meeting that took place in Chicago, USA between May 30-June 4, 2024. The presented results described the validation and release of Telo's proprietary tool, CellSelect-Pro™, that was developed using machine learning and AI platforms, to facilitate high throughput processing of samples while enhancing consistency and accuracy. The tool will favorably impact the sample processing turn-around-time (TAT) with potential cost savings of 20-25% versus manual cell selection in our TeloView myeloma diagnostic tests. The innovative, proprietary algorithm was developed to identify, quantify and process myeloma plasma cells found in the patients' samples being tested. Over 5,000 myeloma positive and negative cells were used to train the AI algorithm, which was validated by processing over 20 myeloma patients' samples. CellSelect-Pro achieved accuracy of >90% and percision of >80% in the conducted validation. The tool was successfully implemented into Telo's testing workflows. The primary clinical application for CellSelect-Pro is Telo's flagship product for smoldering multiple myeloma (SMM) patients, TeloViewSMM, offered now in the USA through the Company's SMART program (Smoldering Multiple myeloma Assessment of Risk for Transformation). CellSelect-Pro was also implemented in the workflow of Telo's active MRD (Minimal Residual Disease) clinical trial for treated multiple myeloma patients, conducted in collaboration with the McGill University, Montreal, Canada. Telo recently announced a major publication of its key SMM clinical study, "Three-dimensional telomere profiling predicts risk of progression in smoldering multiple myeloma," in the American Journal of Hematology. The article describes the significant results achieved with Telo's prognostic test for smouldering multiple myeloma (TeloViewSMM). The article is now available online on the Journal website at . Sherif Louis, Telo's President & CTO commented, "We are very proud to introduce CellSelect-Pro to our Advisors, Collaborators and Partners at ASCO; and were encouraged by the level of interest and positive response at our booth in ASCO from some of the leading institutions in treating myeloma. The validation and implementation of this AI based tool is another milestone demonstrating the viability and readiness of TeloView technology for commercialization and partnerships with Pharma and Diagnostics industry leaders". About ASCO The American Society of Clinical Oncology, Inc. and the Association for Clinical Oncology are committed to the principle that knowledge conquers cancer and represent nearly 45,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of high quality, equitable patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. The ASCO annual meeting is considered one of the top clinical international meetings focused on clinical management of cancers and attracts more than 35,000 attendees every year. About Multiple Myeloma Multiple myeloma (MM) is a challenging and potentially deadly blood cancer that involves plasma cells, a type of blood cell that helps to fight infection. It is the second most common blood cancer with an incidence of 35,000 new cases every year in the US, and ~180,000 patients receiving treatment at any given time. The introduction of next-generation therapies (including targeted treatments) has increased the median survival rate to over 5 years, but MM is still considered incurable. Two asymptomatic precursors, Monoclonal Gammopathy of Unknown Significance ("MGUS") and SMM generally precede the progression to classic symptomatic MM. While MGUS carries a steady risk of progression of 1% per year, SMM is more heterogenous with nearly 40% of patients progressing in the first 5 years, 15% in the next 5 years, reaching the same low risk as MGUS after 10 years. To date, identifying patients who will more rapidly progress to MM remains an important clinical need. MM treatment includes various combinations of drugs with a cost as high as $150,000 per year per patient. As most patients will develop resistance to treatment and relapse within a median of 2 years, identifying them proactively remains another important clinical need. Notably, the total addressable market for both MM assays is over 750,000 tests per year in the US. About TELO Telo Genomics Corp. is a biotech company pioneering the most comprehensive telomere platform in the industry with powerful applications and predictive/prognostic solutions. These include liquid biopsies and related technologies in oncology and neurological diseases. Liquid biopsy is a rapidly growing field of significant interest to the medical community for being less invasive and more easily replicated than traditional diagnostic approaches. By combining our team's considerable expertise in quantitative analysis of 3D telomeres with molecular biology and artificial intelligence to recognize disease associated genetic instability, Telo is developing simple and accurate products that improve day-to-day care for patients by serving the needs of pathologists, clinicians, academic researchers and drug developers. The benefits of our proprietary technology have been substantiated in 160+ peer reviewed publications and in 30+ clinical studies involving more than 3,000 patients with multiple cancers and Alzheimer's disease. Our lead application, TeloView-MM is being developed to provide important, actionable information to medical professionals in the treatment of multiple myeloma, a deadly form of blood cancer. For more information, please visit . For further information, please contact: Sherif Louis, President & CTO Telo Genomics 416-673-8487 Neither the TSX Venture Exchange nor its Regulation Services Provider (as such term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Cautionary Note Regarding Forward-Looking Statements Certain information contained herein may constitute "forward-looking information" under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as "intends", "will", or variations of such words and phrases or statements that certain actions, events or results "will" occur. Forward-looking statements regarding the clinical efficacy of products, commercial viability of products, use of proceeds, and the ability of the TeloView® platform to deliver personalized medicine resulting in better treatments and outcomes are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward- looking statements and forward-looking information. The Company will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws. To view the source version of this press release, please visit