Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the “Company” or “Telo”) is pleased to announce that it has recently completed the interim assessment of its systems and protocols for ISO 15189 certification with over 90% compliance.
Toronto, Ontario--(Newsfile Corp. - March 15, 2023) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the “Company” or “Telo”) is pleased to announce that it has recently completed the interim assessment of its systems and protocols for ISO 15189 certification with over 90% compliance. ISO 15189 is the international standard specific for clinical laboratories. The completion of this critical step qualifies Telo to advance to the external audit stage, which is the final stage of the ISO certification process.
In 2022, Telo began the adoption of the policies and the quality management system (QMS) required to qualify for ISO 15189. The process also included the implementation of a world class document control system and laboratory Information Management System (LIMS). Achieving the ISO certification will allow Telo to offer laboratory developed tests (“LDT”) commercially and issue patient reports nationally and internationally.
The interim assessment was conducted by an external ISO consultant with over 15 years of experience of successfully guiding clinical laboratories through the ISO certification process. Telo expects the external audit to be completed by the end of the second quarter of 2023.
“We are thrilled to complete the ISO interim assessment with such a high level of compliance,” said Sherif Louis, Telo Genomics President & CTO. “Achieving the ISO certification will maximize Telo’s potential to engage in partnerships with pharma and diagnostics industry and offer TeloView products as a value-added test in clinical trials for drug development.”
Telo’s lead product is designed to identify high-risk smoldering multiple myeloma (“SMM”) patients who are likely to benefit from earlier treatment intervention. The test also identifies the larger subset of low-risk SMM patients who have a more stable form of the disease and do not require immediate treatment. These patients can be regularly monitored using TeloView-MM. There are approximately 200,000 SMM patients in the US that could benefit from the TeloView test and ongoing monitoring. The Company’s second assay is designed to identify newly diagnosed multiple myeloma patients who are most likely to develop treatment resistance and relapse earlier than expected.
About Multiple Myeloma
Multiple myeloma 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 www.telodx.com.
For further information, please contact:
Kris Weinberg, CEO
678-429-5582
kris.weinberg@telodx.com
MaRS Centre, South Tower,
101 College Street, Suite 200, Toronto, ON, M5G 1L7 www.telodx.com
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.
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