Telo Genomics Receives CLIA Certification
Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) has received CLIA certification from the US Centers for Medicare & Medicaid Services. This important milestone allows Telo to offer its clinical laboratory services within the USA and develop and validate its TeloView prognostic products for distribution in the USA and other international jurisdictions recognizing International CLIA accreditation.
The CLIA certification, combined with the recently achieved CAP accreditation, enables Telo to demonstrate the viability of its TeloView prognostic products to potential US partners. This achievement is expected to advance Telo's platform of prognostic tests across oncology and empower ongoing partnership development efforts with key industry players, particularly in smoldering and minimal residual disease (MRD) in multiple myeloma.
Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) ha ricevuto la certificazione CLIA dai Centri statunitensi per Medicare e Medicaid Services. Questo importante traguardo consente a Telo di offrire i suoi servizi di laboratorio clinico negli Stati Uniti e di sviluppare e convalidare i suoi prodotti prognostici TeloView per la distribuzione negli USA e in altre giurisdizioni internazionali che riconoscono l'accreditamento CLIA internazionale.
La certificazione CLIA, unita all'accreditamento CAP recentemente ottenuto, permette a Telo di dimostrare la validità dei suoi prodotti prognostici TeloView a potenziali partner statunitensi. Questo risultato si prevede che potenzi la piattaforma di test prognostici di Telo in oncologia e favorisca gli sforzi in corso di sviluppo di partnership con attori chiave del settore, in particolare per quanto riguarda la malattia in fase smouldering e la malattia minima residua (MRD) nel mieloma multiplex.
Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) ha recibido la certificación CLIA de los Centros de Servicios de Medicare y Medicaid de EE. UU. Este importante hito permite a Telo ofrecer sus servicios de laboratorio clínico dentro de EE. UU. y desarrollar y validar sus productos pronósticos TeloView para la distribución en EE. UU. y otras jurisdicciones internacionales que reconocen la acreditación CLIA internacional.
La certificación CLIA, combinada con la acreditación CAP recientemente lograda, permite a Telo demostrar la viabilidad de sus productos pronósticos TeloView a posibles socios estadounidenses. Se espera que este logro avance la plataforma de pruebas pronósticas de Telo en oncología y fortalezca los esfuerzos de desarrollo de asociaciones con actores clave de la industria, particularmente en enfermedad smouldering y enfermedad mínima residual (MRD) en mieloma múltiple.
Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF)는 미국 Medicare 및 Medicaid 서비스 센터로부터 CLIA 인증을 받았습니다. 이 중요한 이정표는 Telo가 미국 내에서 임상 실험실 서비스를 제공하고, TeloView 예측 제품을 개발하고 검증하여 미국 및 국제적으로 CLIA 국제 인증을 인정하는 다른 법역에서 유통할 수 있도록 합니다.
CLIA 인증은 최근에 달성한 CAP 인증과 결합되어 Telo가 TeloView 예측 제품의 실행 가능성을 잠재적인 미국 파트너에게 증명할 수 있도록 합니다. 이 성과는 온코로지 분야에서 Telo의 예측 테스트 플랫폼을 더욱 발전시키고 주로 다발성 골수종에서 미열과 최소 잔여 질병(MRD)을 포함한 주요 산업 플레이어와의 지속적인 파트너십 개발 노력에 도움을 줄 것으로 기대됩니다.
Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) a reçu la certification CLIA des Centres américains de Medicare et Medicaid Services. Ce jalon important permet à Telo d'offrir ses services de laboratoire clinique aux États-Unis et de développer et valider ses produits pronostiques TeloView pour une distribution aux États-Unis et dans d'autres juridictions internationales reconnaissant l'accréditation CLIA internationale.
La certification CLIA, combinée à l'accréditation CAP récemment obtenue, permet à Telo de démontrer la viabilité de ses produits pronostiques TeloView à des partenaires américains potentiels. Cet accomplissement devrait faire progresser la plateforme de tests pronostiques de Telo en oncologie et renforcer les efforts en cours de développement de partenariats avec des acteurs clés de l'industrie, notamment dans le cas de la maladie d'évolution lente et de la maladie résiduelle minimale (MRD) dans le myélome multiple.
Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) hat die CLIA-Zertifizierung von den US-amerikanischen Zentren für Medicare und Medicaid Services erhalten. Dieser wichtige Meilenstein ermöglicht es Telo, seine klinischen Laborleistungen in den USA anzubieten und seine TeloView-Prognoseprodukte für den Vertrieb in den USA und in anderen internationalen Rechtsordnungen, die die internationale CLIA-Akkreditierung anerkennen, zu entwickeln und zu validieren.
Die CLIA-Zertifizierung in Verbindung mit der vor kurzem erreichten CAP-Akkreditierung ermöglicht es Telo, die Einsatzfähigkeit seiner TeloView-Prognoseprodukte potenziellen US-Partnern zu demonstrieren. Diese Errungenschaft wird voraussichtlich dazu beitragen, die Plattform von Telo für prognostische Tests in der Onkologie voranzubringen und die fortlaufenden Partnerschaftsentwicklungsbemühungen mit wichtigen Akteuren der Industrie, insbesondere bei schwelenden und minimalen Restkrankheiten (MRD) bei multiplem Myelom, zu stärken.
- Received CLIA certification, allowing clinical laboratory services in the USA
- Can now develop and validate TeloView prognostic products for US and international distribution
- CLIA certification combined with CAP accreditation enhances credibility with potential US partners
- Enables commercialization of TeloView diagnostic tests
- None.
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.
For further information, please contact:
Sherif Louis,
President & CTO
Telo Genomics
416-673-8487
www.telodx.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as such term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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 (TDSGF) receiving CLIA certification?
How does the CLIA certification impact Telo Genomics' (TDSGF) business prospects?
What is TeloView and how does it relate to Telo Genomics' (TDSGF) CLIA certification?
What other accreditation does Telo Genomics (TDSGF) have besides CLIA?
