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THE MARKET NEED

Correct Treatment Decisions Presents An Important Healthcare Market

Incidence of cancer is growing worldwide and some cancers continue to show high mortality rates. Tests that focus on early detection as well as treatment selection therefore assume considerable importance in improving patient quality of life and providing good healthcare.

Therapy administration is common in all cancer patients. First-line therapy (first regimen of drugs given to patient) has the best chance of effectiveness measured by high five- and ten-year survival rates. Incorrect treatment choice often leads to cancer recurrence, metastasis and possible death - a high cost to patients, hospitals and insurers. Patient mortality and care in metastasis are the highest fraction of direct medical costs in cancer care. Even a modest 10% increase in complete cancer removal from choice of correct treatment can save an estimated $500 million annually in healthcare costs.

No Test Is Currently Available For Chemotherapy Selection

Breast cancer affects about 211,000 women in the US and about 1.2 million worldwide each year. About 70% of all breast cancer patients undergo chemo-treatment. Different chemo-regimens commonly used in breast cancer are effective but differ widely in cost, duration, and toxicity at comparable efficacy. Treatment selection is based on pathology measurements of tumor size, stage and grade that can be subjective. Although some single-marker tests are used in selecting specific therapies, they do not direct to a positive clinical outcome from a specific therapy. Patient response to therapies today is highly variable.

A Diagnostic Test Needs To Demonstrate Clinical Outcome
Adoption of diagnostic tests by oncologists and patients can be achieved today only from demonstration of a proven clinical outcome such as survival. A distinguishing competitive feature of Nuvera's product development approach is that the multi-gene predictor profiles are discovered from prospective IRB-approved clinical trials at MD Anderson Cancer Center. Clinical validation of predictors is being also accomplished with prospective trials at sites in the US and overseas.

Market Need