Toronto, Ontario--(Newsfile Corp. - August 13, 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 US Centres of Medicare & Medicaid Services (CMS) which regulates the medical laboratories in the USA, has awarded Telo its Clinical Laboratory Improvement Amendment ("CLIA") certificate of registration, as a certified medical clinical laboratory. Telo's registration is within the international stream of CLIA.
The CLIA registration and accreditation allows Telo to offer its clinical laboratory services within the USA. The CLIA accreditation also allows the Company to develop and validate its novel TeloView prognostic products and distribute them in the USA and all other international jurisdictions that recognize the International CLIA accreditation. This is a crucial step necessary in making the TeloView diagnostic tests widely available for commercial use and will help advance Telo's platform of prognostic tests across the field of oncology. The CLIA certification, together with the recently achieved CAP accreditation enables Telo to demonstrate to potential US partners the viability of the TeloView prognostic products.
Telo worked diligently with the US Centres of Medicare & Medicaid Services for over a year to achieve the CLIA certification, which will entitle the Company to validate its own laboratory tests and add them to its prognostic testing menu.
"The CLIA designation is a game changing milestone for Telo on its path towards commercialization," said Jay Wohlgemuth, MD, Managing Partner of Trusted Health Advisors, a strategic advisor to Telo. "Offering the TeloView portfolio of tests as CLIA tests will empower the ongoing partnership development efforts with key industry players in the diagnostic landscape, particularly in respect to ongoing discussions in smoldering and minimal residual disease ("MRD") in multiple myeloma."
About CLIA
The Clinical Laboratory Improvement Amendments of 1988 (42 USC 263a) and the associated regulations (42 CFR 493) were established by the US Food and Drug Association (FDA) and provides the authority for certification and oversight of clinical laboratories and laboratory testing. CLIA is the supreme US federal program, regulated by the US Food and Drug Association, to govern the quality and accuracy of clinical testing in the US and internationally. CLIA-designated laboratories are authorized to offer clinical testing in the US, particularly laboratory developed tests (LDTs).
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 www.telodx.com.
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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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