Mayo Clinic

Study 1 – A retrospective study designed to stratify patients between those with stable SMM and those with high-risk SMM

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.

Study 2 – A retrospective study designed to stratify multiple myeloma patients between those who failed initial therapy from those who went into remission

There are dozens of combinations of therapies that are used to treat multiple myeloma including combinations of; chemotherapy, immunotherapy, proteasome inhibitors, stem cell therapy and radiation.

Multiple myeloma is a challenging form of blood cancer and patients don’t always respond to therapy. Patients will build up resistance to treatment, forcing them to switch the combination of therapies multiple times over the course of the disease.

In this validation study, TeloView^® will be used to predict whether patients will respond to the proposed first-line therapy. Importantly, treating multiple myeloma is expensive, ranging from $125,000 to $250,000 per year. Choosing an effective initial therapy is important to control the disease and to save costs.

There are approximately 32,000 new cases of multiple myeloma per year in the US. TeloView^® could ultimately be applicable when choosing initial therapy and for any further changes in the combination therapy for patients going forward. The addressable market for predicting the effectiveness of a proposed therapeutic combination is estimated to be up to 100,000 tests per year.

Collaborative Clinical Studies - The Mayo Clinic

Study 1 – A retrospective study designed to stratify patients between those with stable SMM and those with high-risk SMM

Study 2 – A retrospective study designed to stratify multiple myeloma patients between those who failed initial therapy from those who went into remission