Cancer is a highly individualized disease

The American Cancer Society estimates that close to 1.5 million people are diagnosed with cancer annually in the U.S. and more than 550,000 die as a result of the disease. In 2009, the National Institutes of Health estimated the 2008 direct medical costs (total of all health expenditures) were $93.2 billion with the total cost (including lost productivity due to illness and death) of $228.1 billion. These costs are growing, driven by increases in early detection and an aging population.

Cancer is a highly individualized disease. Since every tumor has distinct characteristics, targeted drug treatment is the preferred approach. Effective treatment relies on selecting a specific drug that targets a patient’s unique tumor(s). Unfortunately, there are often significant side effects, as well as costs that can exceed $30,000 per year for one patient.

The need for multiple target identification is critical. It is no longer sufficient to merely identify a person who may or may not have cancer. Now, the challenge is to develop individualized treatment regimens that will effectively treat that patient’s disease.

Modest success rate of anticancer drugs

Anticancer drugs are approved by FDA on the basis of the clinical trial results from a population of cancer patients. A 20-30% response rate may win a drug regimen FDA approval. These population-based results cannot be applied directly to individual patients because cancer is a highly individualized disease.

Currently, there is no standard procedure for optimal anticancer therapy treatment selection.

DirectHit®: Targeted Diagnostics for Breast Cancer Therapy

Clinical trial results show that DirectHit Test Panel for Breast Cancer predicts both resistance and sensitivity to four commonly prescribed classes of breast cancer treatments with a high degree of accuracy.

Drug Class	Biomarker	Our accuracy when we predict the tumor will be sensitive	Our accuracy when we predict the tumor will be resistant
Antiestrogens	Estrogen Receptor (ER)	94%	100%
Trastuzumab	HER-2	100%	100%
Taxanes/Vinca Alkaloids	Beta Tubulin III	86%	100%
5-FU/Capecitabine	Thymidylate Synthase (TS)	80%	100%

In addition, the following are currently in development: Anthracyclines (topoisomerase IIa), Platinum Drugs (ERCC-1) and Gemcitabine (ribonucleotide reductase).