Telo Genomics Completes International Standards Organization ("ISO") 15189 Final Accreditation
Telo Genomics Completes International Standards Organization ("ISO") 15189 Final Accreditation
Authorizes Telo to Offer its Laboratory Developed Tests ("LDT") from its Central Lab
授權Telo在其中心實驗室提供實驗室開發的測試(LDT
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.
安大略省多倫多-(Newsfile Corp.-2023年10月26日)-Telo基因公司(TSXV：TELO)(OTCQB：TDSGF)(“公司“或”Telo)很高興地宣佈，它已經通過了所有要求並獲得了ISO 15189認可證書。重要的是，嚴格的ISO 15189是專門針對醫學實驗室的國際標準，也是TELO基因組公司新型癌症檢測平臺商業化的關鍵完成，該平臺基於測量基因組不穩定性的端粒3D分析。
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.
加拿大診斷認證(ACD)評估提供了對能力的認可，並強調了該設施的經驗、卓越的技術能力和可靠性。此外，國際實驗室認可協會是國際實驗室認可合作組織及其亞太區域認可合作組織相互承認安排的簽署國(國際標準化組織15189)。根據這一MRA頒發的證書得到了世界範圍的認可，包括105個國家和地區的Ilac的104個簽字國。
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.
該認證還驗證了護理點測試(POCT)，該測試授權Telo在多倫多的中心實驗室提供其開發的測試，該中心位於火星發現區，是世界上最大的致力於醫學和相關科學的創新中心。
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.
Telo Genology最初的商業啟動將專注於測試陰燃多發性骨髓瘤(SMM)，這是多發性骨髓瘤(MM)的先兆，MM是一種致命的血源性骨髓癌。美國有超過300,000名SMM患者，每年有可能測試SMM進展為MM兩次或更多次的可能性。
"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."
TELO公司首席執行官克裡斯·溫伯格說：“在我們的TELOVIEW-SMM測試在美國商業推出的同時，獲得了我們的國際標準化組織15189認證證書，為骨髓瘤護理社區的實驗室和醫生提供了對我們平臺的額外一層信心。國際標準化組織15189認證證實了Teloview作為一個綜合平臺的效用，它能夠提供關於多種適應症和用例的資訊。我們期待著將我們的努力貨幣化，並通過合作夥伴關係與製藥公司和臨床研究機構充分利用機會。“
About TeloView-SMM
關於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.
TeloView-SMM有可能成為醫生管理診斷為陰燃多發性骨髓瘤患者護理的重要工具。這種專有的檢測(以及相關的平臺技術)通過測量端粒的3D結構和空間組織來量化個體患者轉化/進展的風險。這一分子特徵確定了可能從早期治療幹預中受益的高危SMM患者。較大的低風險患者亞群可能不需要立即治療，可以使用TeloView-SMM分析和標準表型測量一起定期監測。美國目前有超過20萬名患者患有陰燃的多發性骨髓瘤。TeloView-SMM測試的潛在總市場每年超過500,000次測試。
About Telo Genomics
關於Telo基因組學
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 .
Telo基因公司是一家生物技術公司，憑藉強大的應用程式和預測/預測解決方案，開創了業內最全面的端粒平臺。這些包括腫瘤學和神經系統疾病的液體活組織檢查和相關技術。液體活檢是一個迅速增長的領域，醫學界對此非常感興趣，因為它比傳統的診斷方法侵入性更小，更容易複製。通過將我們團隊在3D端粒定量分析方面的豐富專業知識與分子生物學和人工智慧相結合，以識別與疾病相關的遺傳不穩定性，Telo正在開發簡單而準確的產品，通過服務於病理學家、臨床醫生、學術研究人員和藥物開發商的需求，改善對患者的日常護理。我們的專利技術的好處已經在160多篇同行評議的出版物和30多項臨床研究中得到證實，這些研究涉及3000多名患有多發性癌症和阿爾茨海默病的患者。我們的領先應用程式TeloView-MM正在開發中，旨在為治療多發性骨髓瘤(一種致命的血癌)的醫療專業人員提供重要的、可操作的資訊。欲瞭解更多資訊，請訪問。
For further information, please contact:
如需更多資訊，請聯繫：
Kris Weinberg, CEO
678-429-5582
kris.weinberg@telodx.com
MaRS Centre, South Tower,
101 College Street, Suite 200, Toronto, ON, M5G 1L7
首席執行官克裡斯·溫伯格
678-429-5582
郵箱：kris.weinberg@telodx.com
火星中心，南塔，
安大略省多倫多大學街101號200套房，郵編：M5G 1L7
Cautionary Note Regarding Forward-Looking Statements
有關前瞻性陳述的注意事項
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.
根據加拿大證券法，本文中包含的某些資訊可能構成“前瞻性資訊”。一般而言，前瞻性資訊可以通過使用前瞻性術語來識別，例如“打算”、“將”，或這些詞語和短語的變體，或關於某些行動、事件或結果“將”發生的陳述。關於產品的臨床療效、產品的商業可行性、收益的使用以及TeloView的能力的前瞻性陳述提供個性化藥物以帶來更好的治療和結果的平臺是以公司的估計為基礎的，受已知和未知的風險、不確定性和其他因素的影響，這些因素可能會導致公司的實際結果、活動水準、業績或成就與這些前瞻性陳述或前瞻性資訊中明示或暗示的內容大不相同，包括資本支出和其他成本。不能保證這些陳述將被證明是準確的，因為實際結果和未來事件可能與這些陳述中預期的大不相同。因此，讀者不應過分依賴前瞻性陳述和前瞻性資訊。除非適用的證券法要求，否則公司不會更新任何通過引用納入本文的前瞻性陳述或前瞻性資訊。
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