The standard of care for patients that have been diagnosed with SMM has been to monitor but not treat. There is a movement toward treating patients identified in the high-risk category to delay the onset of active multiple myeloma and its debilitating symptoms. However, this therapeutic approach has been limited by the lack of a reliable, non-invasive prognostic test for high-risk SMM.
Current diagnosis for SMM is a simple blood test followed by an invasive bone marrow biopsy. TeloView® has demonstrated in previous clinical studies to have the potential to fill this void (see publications); it is non-invasive and can be used repeatedly for monitoring.
The incidence of SMM in the US is 250,000 and between 10-15% of these SMM patients transition to active multiple myeloma per year. The addressable market for prognostic testing and monitoring of SMM is estimated to be up to 500,000 tests per year.
There are significant benefits to providing a reliable, non-invasive prognostic test for SMM patients. Most SMM patients are in the low to intermediate category and will not require treatment. This vital information would significantly improve the quality of life and provide peace of mind for these patients.
For patients categorized as high-risk, increased monitoring and the possibility of early treatment offers the probability of better clinical outcomes and the delay of the painful, life altering symptoms of active multiple myeloma.
