Telo Genomics Corp. 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 83% and specificity (accuracy in identifying stable patients) of 76%. The validation was recently published by the American Journal of Hematology (AJH).

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.