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Focus On Cancer
TDI has selected oncology as its initial focus for Isonostics™ development, in critical applications where existing diagnostics are unavailable or inadequate. Clinical research is revealing that isoform changes are critically relevant, and there are compelling motives for improved patient outcomes and for significant health economic benefits. TDI’s first three Isonostic™ products will address prostate cancer aggressiveness, and chemotherapy selection in breast and ovarian cancer.
For 6 of the 12 most common cancers in the United States, no in-vitro diagnostic test (IVD) exists. Existing IVDs for the other 6 cancers are focused on early detection or treatment monitoring, leaving virtually unaddressed questions on how to best treat a specific patient. There is a pressing need for diagnostics that can identify aggressive cancers, to select those patients who require aggressive treatment from those who do not, and to select which chemotherapy alternative is optimal for each patient.
Clinical research is expanding the evidence that the presence and ratios of specific protein isoforms correlate to cancer diagnosis, staging, progression and therapeutic response far better than traditional immunodiagnostic measurements of protein abundance (the sum of all isoforms). Isonostic™ assays that separate and quantify the relative levels of specific protein isoforms will provide physicians and patients with improved disease insights and enable better treatment decisions.
Better Decisions About Prostate Cancer TreatmentRecent data indicates that 93% of patients with prostate cancer receive aggressive treatment, such as radical prostatectomy and/or radiation. These treatments are costly, invasive and distressing, and produce surprisingly high side effect rates for urinary incontinence and erectile dysfunction. Clinical research suggests that for 84-98% of patients such aggressive therapy is unnecessary. The absence of an effective diagnostic test to discriminate aggressive tumors versus the normally slow progression of prostate cancer has forced doctors and patients to opt for aggressive treatment in almost all cases. An effective tumor aggressiveness diagnostic could offset an estimated $0.9-2.3B in current annual US healthcare expenditures, and could dramatically improve quality of life for the majority of patients appropriately avoiding aggressive treatment.
Better Decisions About Chemotherapy in Breast CancerApproximately 65% of the 235,000 Americans diagnosed with breast cancer annually have ductal carcinomas in situ (DCIS). Due to tremendous advances in early detection, these tumors are typically pre-metastatic (non-invasive). Clinicians currently struggle with limited ability to predict which tumors are aggressive and merit a course of adjuvant chemotherapy. Consequently, about 80% of DCIS patients have traditionally elected to undergo adjuvant chemotherapy as a precautionary measure. The side effects of chemotherapy are often onerous, and clinical research suggests that less than 30% of these patients derive any survival benefit from this treatment. A diagnostic that accurately discriminates patients for whom adjuvant chemotherapy would be a net benefit from those who could safely avoid it could offset $0.4-3.1B per year in current annual US healthcare expenditures, and would spare up to 50% of DCIS patients from the debilitating side effects of chemotherapy.
Better Decisions on Ovarian Cancer Chemotherapy SelectionFor the 25,000 women diagnosed annually with ovarian cancer in the US, there are important chemotherapy alternatives to be considered. In accordance with current practice standards, nearly all patients are first treated with a platin/taxol combination, the most efficacious 1st-line chemotherapy. However, approximately 30% of patients receive no benefit and another 50% stop responding within 6 months. Surviving non-responders are advanced through subsequent rounds of alternate chemotherapy agents. Å diagnostic test that could identify non-responders preemptively would help clinicians to advance these patients on to alternative chemotherapies right away, potentially delaying disease progression, improving quality and extending life. The platin/taxol 1st-line therapies appropriately avoided would also offset an estimated $0.2-0.5B in current annual US healthcare expenditures.
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