Lung cancer is the leading cause of cancer death

Lung cancer is the leading cause of cancer death in the western world and accounts for more deaths than breast cancer, prostate cancer and colon cancer combined.  Lung cancer is the number two most common cancer afflicting over 213,000 individuals per year in the United States alone. Approximately 85% of all lung cancers are of the non-small-cell variety (NSCLC).  LungExpress Dx™ is targeted towards early-stage NSCLC (stage I and II), a disease which afflicts over 74,000 persons annually in the United States alone (Jemal, Cancer Statistics, 2008).

Approximately $9.6 billion is spent annually in the United States on lung cancer diagnosis and treatment (NCI Cancer Trends Progress Report – 2007 Update).  The value of life lost in the United States from all cancer deaths in the year 2000 was $960.6 billion; lung cancer alone represented more than 25% of this value (Yabroff, K.R., 2008).

Clinical staging alone is inadequate; better prognostic tools are urgently needed

Early-stage NSCLC patients are treated primarily by surgical removal of their tumours.  Recent clinical trials have established that adjuvant chemotherapy, administered after tumour removal, significantly improves the survival of stage II patients, but does not significantly improve the survival of stage I patients. 

As a result, the American Society of Clinical Oncology and National Comprehensive Cancer Network recommend adjuvant chemotherapy for stage II patients but not for stage I patients.  However, 30% to 55% of stage I and II patients still die as a result of the disease, implying that patients diagnosed with the same stage of disease can have markedly different treatment responses and overall outcomes.  Currently, tumor stage (determined by the size and location of the tumour and lymph node involvement) remains the strongest predictor of survival but fails to account for this difference in patient outcomes.  A more accurate means of prognostication is needed to improve the selection of patients for adjuvant chemotherapy. GeneFx® Lung is expected to help address this critical unmet need.