Telo Genomics Completes International Standards Organization ("ISO") 15189 Final Accreditation
- Telo Genomics Corp. has received its Certificate of Accreditation of ISO 15189, allowing it to offer its Laboratory Developed Tests (LDT) internationally.
- None.
Authorizes Telo to Offer its Laboratory Developed Tests ("LDT") from its Central Lab
Toronto, Ontario--(Newsfile Corp. - October 26, 2023) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the "Company" or "Telo") is pleased to announce that it has passed all requirements and received its Certificate of Accreditation of ISO 15189. Importantly, the rigorous ISO 15189 is the international standard specific for medical laboratories and a key ccomplishment in the commercialization of Telo Genomic's platform of novel cancer assays, which are based-on the 3D analysis of telomeres in measuring genomic instablility.
Accreditation Canada Diagnostics (ACD) assessment provides recognition of competence and underscores the facility's experience, superior technical competence and reliability. In addition, ACD is a signatory (ISO 15189) to the Mutual Recognition Arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC) and its regional Asia Pacific Accreditation Cooperation (APAC). Certificates granted under this MRA are recognized world-wide including by ILAC's 104 signatories in 105 countries.
The certification also validates Point-of-Care Testing (POCT), which authorizes Telo to internationally offer its developed tests from its central laboratory in Toronto, located at the MaRS Discovery District, the world's largest innovation hub dedicated to medical and related sciences.
Telo Genomics initial commercial launch will focus on testing for Smoldering Multiple Myeloma ("SMM") the precursor for Multiple Myeloma ("MM") a deadly blood based bone marrow cancer. There are over 300,000 patients with SMM in the US, with the potential of testing the likelihood of SMM advancing to MM two or more times per year.
"Receiving our ISO 15189 certificate of accreditation concurrent with the commercial launch of our TeloView-SMM test in the US provides an additional layer of confidence in our platform for laboratories and physicians in the myeloma care community," stated Kris Weinberg, Telo's CEO. "The ISO 15189 accreditation confirms the utility of TeloView as a comprehensive platform capable of informing on multiple indications and use cases. We look forward to monetizing our efforts and to fully exploiting opportunities with pharma and CRO (clinical research organizations) through cooperative partnerships."
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 Telo Genomics
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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FAQ
What is the significance of Telo Genomics receiving the ISO 15189 accreditation?
What will Telo Genomics focus on initially with its commercial launch?
Where is Telo Genomics' central laboratory located?
How many patients in the US have Smoldering Multiple Myeloma (SMM)?
What is the potential of testing the likelihood of Smoldering Multiple Myeloma (SMM) advancing to Multiple Myeloma (MM)?
