share_log

Telo Genomics Advances to the Final Stage of Accreditation From The College of American Pathologists

Telo Genomics Advances to the Final Stage of Accreditation From The College of American Pathologists

Telo Genomics 進入美國病理學家學會認證的最後階段
newsfile ·  2023/11/07 21:45

An Important Accreditation Milestone Achieved Towards Full Commercial Availability

邁向全面商業化的重要認證里程碑

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.

安大略省多倫多--(新聞文件公司-2023 年 11 月 7 日)- Telo Genomics Corp.(多倫多證券交易所股票代碼:TELO)(場外交易代碼:TDSGF)(FSE:3D0A),( “公司” 要麼 “Telo”), 一家開創最全面的人工智能基因組醫學測試的生物技術公司很高興地宣佈,美國病理學家學會(CAP)認證辦公室已通知該公司,其認證申請已成功完成。

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.

該公司現在可以進行外部評估審計,這是獲得高價值的CAP認證的最後一步。CAP 認證流程旨在確保爲所有實驗室患者提供最高標準的護理,在此期間,檢查員會檢查實驗室的記錄並對程序進行質量控制。CAP 檢查員還檢查實驗室工作人員的資格、設備、設施、安全計劃和記錄以及整體管理。

Telo Genomics expects to complete the CAP audit within the first quarter of 2024.

Telo Genomics預計將在2024年第一季度內完成CAP審計。

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.

CAP 開展的認證程序還將包括向Telo授予 《臨床實驗室改善修正案》 (CLIA) 稱號。CLIA指定的實驗室有權在美國提供臨床測試,特別是實驗室開發的測試(LDT)。這是使TeloView診斷測試廣泛用於商業用途的必要步驟。

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.

Telo 的實驗室設施及其 TeloView 系統將有資格成爲 基因組學分子病理學 CAP/CLIA 測試類別組合中的測試平台。

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.

爲了進入認證過程的最後階段,Telo在過去的一年中一直與CAP認證辦公室辛勤工作。Telo還進行了嚴格的內部差距分析,以滿足認證要求。

"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."

Telo總裁兼首席技術官謝里夫·路易斯說:“經過大量的工作,我們很高興進入CAP和CLIA認證程序的最後階段。”“除了我們最近獲得的ISO 15189臨床實驗室認證外,我們還準備在商業上提供符合並超出治療醫生、製藥合作伙伴和CRO期望的最高標準的TeloView測試。CAP/CLIA認證應促進Teloview-SMM預測測試在美國的廣泛採用。”

About CAP & CLIA

關於 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.

美國病理學家學會(CAP)成立於1946年,是獲得董事會認證的病理學家的領先組織。CAP 通過促進和倡導全球病理學和實驗室醫學的卓越實踐,爲患者、病理學家和公衆提供服務。1988年臨床實驗室改進修正案(CLIA)(42 USC 263a)和相關法規(42 CFR 493)由美國食品和藥物管理局制定,爲臨床實驗室和實驗室測試的認證和監督提供了權力。

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 有可能成爲醫生管理被診斷患有悶燒性多發性骨髓瘤患者的護理的重要工具。專有檢測(及相關的平台技術)通過測量端粒的三維結構和空間組織來量化個體患者的轉化/進展風險。這種分子特徵可以識別可能從早期治療干預中受益的高危SMM患者。較大部分的低風險患者可能不需要立即治療,可以使用 TeloView-SMM 測定法以及標準表型測量進行定期監測。目前,美國有超過20萬名患者患有悶燒的多發性骨髓瘤。Teloview-SMM測定的潛在潛在潛在市場每年超過50萬次測試。

About Multiple Myeloma

關於多發性骨髓瘤

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.

多發性骨髓瘤是一種具有挑戰性且可能致命的血液癌,它涉及漿細胞,一種有助於抵抗感染的血細胞。它是第二常見的血液癌,在美國每年有35,000例新發病例,在任何給定時間都有大約18萬名患者接受治療。下一代療法(包括靶向治療)的引入使中位存活率提高到5年以上,但多發性硬化症仍被認爲是無法治癒的。兩種無症狀前體,即意義未知的單克隆丙種球蛋白病(“MGUS”)和 SMM 通常先於典型症狀性 MMM 的進展風險。儘管 MGUS 的穩定進展風險爲每年 1%,而 SMM 則更爲複雜,近 40% 的患者在前 5 年內進展,15% 在未來 5 年內進展,10 年後達到與 MGUS 相同的低風險。迄今爲止,確定能夠更快地發展爲多發性硬化症的患者仍然是一項重要的臨床需求。多發性硬化症治療包括各種藥物組合,每位患者每年的費用高達15萬美元。由於大多數患者將在中位數的2年內出現對治療的耐藥性並復發,因此主動識別他們仍然是另一項重要的臨床需求。值得注意的是,在美國,這兩種MM檢測的總潛在市場每年超過75萬次檢測。

About TELO

關於 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 .

Telo Genomics Corp. 是一家生物技術公司,憑藉強大的應用程序和預測/預測解決方案,開創了業內最全面的端粒平台。其中包括腫瘤學和神經系統疾病的液體活檢和相關技術。液體活檢是一個快速增長的領域,引起了醫學界的濃厚興趣,因爲與傳統的診斷方法相比,液體活檢的侵入性更小,更容易複製。通過將我們團隊在三維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能相結合,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,通過滿足病理學家、臨床醫生、學術研究人員和藥物開發人員的需求,改善患者的日常護理。我們專有技術的益處已在 160 多篇同行評審出版物和 30 多項臨床研究中得到證實,涉及 3,000 多名患有多種癌症和阿爾茨海默病的患者。我們的主要應用程序TeloView-mm正在開發中,旨在爲治療多發性骨髓瘤(一種致命的血液癌)的醫療專業人員提供重要、可操作的信息。欲了解更多信息,請訪問。

For further information, please contact:

欲了解更多信息,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

首席執行官克里斯·溫伯格
678-429-5582
kris.weinberg@telodx.com
MarS 中心、南塔、
安大略省多倫多市學院街 101 號 200 號套房,M5G 1L7

Cautionary Note Regarding Forward-Looking Statements

關於前瞻性陳述的警示說明

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.

根據加拿大證券立法,此處包含的某些信息可能構成 “前瞻性信息”。通常,前瞻性信息可以通過使用前瞻性術語來識別,例如 “打算”、“意願”,或者某些行動、事件或結果 “將” 發生的詞語和短語或陳述的變體。關於產品臨床療效、產品的商業可行性、收益用途和TeloView能力的前瞻性陳述 提供個性化藥物以改善治療和療效的平台基於公司的估計,受已知和未知的風險、不確定性和其他因素的影響,這些因素可能導致公司的實際業績、活動水平、業績或成就與此類前瞻性陳述或前瞻性信息(包括資本支出和其他成本)所表達或暗示的結果存在重大差異。無法保證此類陳述會被證明是準確的,因爲實際結果和未來事件可能與此類陳述中的預期存在重大差異。因此,讀者不應過分依賴前瞻性陳述和前瞻性信息。除非適用的證券法要求,否則公司不會更新此處以引用方式納入的任何前瞻性陳述或前瞻性信息。

To view the source version of this press release, please visit

要查看本新聞稿的源版本,請訪問

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論