An Important Accreditation Milestone Achieved Towards Full Commercial Availability
Toronto, Ontario--(Newsfile Corp. - November 7, 2023) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (FSE: 3D0A), (the "Company" or "Telo"), a biotech company pioneering the most comprehensive A.I. based genomic medical testing, is excited to announce that the College of American Pathologists (CAP) Accreditation Office has informed the company that its certification application has been successfully completed.
The company may now proceed to an external assessment audit, the final step to receiving the highly valued CAP accreditation. The CAP accreditation process is designed to ensure the highest standard of care for all laboratory patients, during which inspectors examine the laboratory's records and quality control of procedures. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and overall management.
Telo Genomics expects to complete the CAP audit within the first quarter of 2024.
The accreditation process conducted by CAP will also include granting Telo the "Clinical Laboratory Improvement Amendment" (CLIA) designation. CLIA-designated laboratories are authorized to offer clinical testing in the US, particularly laboratory developed tests (LDTs). This is a crucial step necessary in making the TeloView diagnostic tests widely available for commercial use.
Telo's laboratory facility and its TeloView system will qualify as a genomics molecular pathology testing platform within the CAP/CLIA portfolio of testing categories.
To reach this final stage of the accreditation process, Telo has worked diligently with the CAP Accreditation Office over the past year. Telo has also conducted rigorous internal gap analysis to address the requirements of the accreditation.
"After a great deal of work, we are thrilled to reach the final stage of the CAP & CLIA accreditation process," said Sherif Louis, Telo's President & CTO. "Along with our recently achieved ISO 15189 clinical laboratory certification we are ready to offer our TeloView tests commercially to the highest level of standards that meet and exceeds the expectation of treating Physicians, Pharma partners and CROs. The CAP/ CLIA accreditation should facilitate a wide adoption of the TeloView-SMM prognostic test in America."
About CAP & CLIA
Founded in 1946, the College of American Pathologists (CAP) is the leading organization of board-certified pathologists. CAP serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 USC 263a) and the associated regulations (42 CFR 493) was established by FDA of the United States and provides the authority for certification and oversight of clinical laboratories and laboratory testing.
About TeloView-SMM
TeloView-SMM has the potential to be an important tool for physicians managing the care of patients diagnosed with Smoldering Multiple Myeloma. The proprietary assay (and associated platform technology) quantifies individual patients' risk of transformation/progression by measuring the 3D structure and spatial organization of telomeres. This molecular signature identifies high-risk SMM patients who are likely to benefit from earlier treatment intervention. The larger subset of low-risk patients may not require immediate treatment and can be regularly monitored using the TeloView-SMM assay along with standard phenotypic measures. Over 200,000 patients in the United States are currently living with smoldering Multiple Myeloma. The TeloView-SMM assay has a potential total addressable market of over 500,000 tests per year.
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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