Telo Genomics Announces Its TeloViewSMM Test Is Accepted as Laboratory Developed Test by CAP
Telo Genomics Corp. announced that its TeloViewSMM test for smoldering multiple myeloma (SMM) has been accepted as a Laboratory Developed Test (LDT) by the College of American Pathologists (CAP). This test, validated with Mayo Clinic and Dana Farber Cancer Institute, identifies high-risk SMM patients with 83% sensitivity and 76% specificity, helping to manage treatment intervention. The test will be added to Telo's CAP-approved menu, allowing it to be offered to US hospitals and cancer centers. CAP's approval was granted without an onsite assessment, reflecting Telo's prior demonstrated excellence.
- TeloViewSMM test accepted by CAP as a Laboratory Developed Test (LDT).
- Test validation demonstrated 83% sensitivity and 76% specificity.
- Collaboration with Mayo Clinic and Dana Farber Cancer Institute for validation.
- CAP approval expands test availability to hospitals, cancer centers, and clinics in the US.
- Accelerated approval without onsite assessment by CAP reflects previous excellence.
- Publication of validation in the American Journal of Hematology boosts credibility.
- Potential for investor concern if the test does not gain wide adoption despite CAP approval.
- Financial impact if the cost of test implementation and monitoring is high.
- Risk of competitive tests entering the market and overshadowing TeloViewSMM.
- Sensitivity and specificity, while high, are not 100%, leaving room for diagnostic errors.
Toronto, Ontario--(Newsfile Corp. - June 18, 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 College of American Pathologists (CAP) has recently accepted Telo Genomics' submission to add Telo's test for smoldering multiple myeloma (SMM), TeloViewSMM, as a Laboratory Developed Test (LDT) on Telo's-CAP approved menu of clinical tests.
The TeloViewSMM test addresses a critical unmet need in the management of SMM patients. The test is capable of identifying SMM patients with the highest risk of progression to full stage multiple myeloma disease, an incurable deadly blood cancer. These patients will benefit from immediate treatment intervention. More importantly, the TeloViewSMM test can also confirm disease stability in low risk SMM patients. These patients can be monitored over time using the TeloViewSMM test without being exposed to unnecessary and uncomfortable expensive treatment.
The validation of TeloViewSMM as a clinical test, was conducted in collaboration with both the Mayo Clinic and the Dana Farber Cancer Institute, and showed superior sensitivity (accuracy in identifying high risk patients) of
Recognized for its rigorous and robust standards, and as one of the world's most prestigious certifying bodies - CAP is mandated to elevate quality and mitigate risk in diagnostic tests to assure improved patient outcomes. Based on the inclusion of the TeloViewSMM test in CAP approved Telo's testing menu, the test can now be offered to hospitals, cancer centers and clinics in the US. CAP has granted TeloViewSMM an accelerated approval waiving the onsite assessment, reflecting and confirming the excellence that Telo has demonstrated during the previous CAP onsite assessment that took place in March 2024.
"Adding the TeloViewSMM to Telo's CAP approved tests menu is the official inauguration of this critical prognostic solution for smoldering myeloma patients as a clinical test," said Sherif Louis, Telo's President & CTO. "We capitalize on developing value added prognostic tests to offer high quality actionable solutions for clinical unmet needs, such as risk-stratifying patients with smoldering multiple myeloma. We look forward to enriching the management of myeloma disease with our MRD tests to monitor post treated patients and accurately identify those with highest risk of relapse prior to the relapse event."
About the College of American Pathologists
As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The CAP has over 23,000 laboratory participants, in addition to accreditation, the CAP offers proficiency testing/external quality assessment (PT/EQA) programs, quality improvement tools, and protocols and guidelines to ensure excellence in all areas across the laboratory. Built on a foundation of pathologist expertise, the College of American Pathologists (CAP) partners with laboratories worldwide to elevate the quality of laboratory medicine with best-in-class solutions designed to drive operational excellence, achieve diagnostic confidence, and ensure the best patient care. For more information on CAP, please visit the CAP Newsroom, CAP.org and yourpathologist.org to see how pathologists work and observe the stories of the patients who trust them with their care.
About Lab Developed Tests
Lab-developed tests are a type of in vitro diagnostic (IVD) tests, which test samples of blood, saliva, or tissue to diagnose and monitor for diseases and conditions. LDT is the most common regulatory format to introduce new innovative clinical diagnostics tests. Like other IVDs, LDTs are intended to be conducted in a professional setting by licensed providers. Many IVDs are designed by one manufacturer and offered by many different laboratories (e.g., a machine to measure blood counts sold to many facilities), but LDTs are different from these other IVDs because they are designed, manufactured, and offered by a single laboratory.
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
sherif.louis@telodx.com
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 TeloViewSMM test?
What is the significance of CAP acceptance for TeloViewSMM?
What are the sensitivity and specificity of the TeloViewSMM test?
Which institutions collaborated on the validation of TeloViewSMM?
Where can I find the published validation results for TeloViewSMM?
What is the impact of the TeloViewSMM test on smoldering multiple myeloma patients?
