Cancer drug research is gradually shifting from traditional cytotoxic chemotherapies toward higher specificity immunological and biological approaches that target unique biochemical receptors and signalling pathways. These new drugs will be more cancer- and patient-specific and will have the potential for slowing cancer growth and inhibiting disease progression, with fewer adverse effects on the patient. As these drugs come to market, in vitro diagnostics will become critical to matching drug to cancer and to patient and then the monitoring of the drug's action on the disease.

The demand for more sophisticated diagnostics continues to grow and synergies between tests and new therapeutics emerge. In vitro diagnostic tests for cancer will continue to grow at a rate of 13 per cent per year for the next several years. The worldwide market for in vitro cancer diagnosis is expected to reach $7.4 billion by 2009, as the demand for such tests will continue to increase as new cancer cases soar toward the 10 million mark.

Cancer patients undergo many different types of tests to accurately diagnose their disease, determine their prognosis, and monitor their cancer for progression or recurrence. Diagnostic tests may be used to:

• Diagnose primary disease — identify the disease the first time it occurs
• Identify cancer subtype — some cancers are divided into subtypes that are more or less aggressive; identification of a more aggressive subtype may influence the type of treatment proposed
• Predict prognosis — test results may indicate the chance of cure, based on outcomes of other patients with similar results
• Direct treatment — cancer is many different diseases, all of which respond differently to various treatments. A diagnosis that accurately identifies the type of cancer and predicts prognosis will also help to identify the type of treatment that maximizes the chance of cure.
• Predict response to treatment — some tests predict whether a specific therapy is likely to be effective
• Evaluate response to treatment — some tests show whether the cancer is responding to treatment
• Detect minimal residual disease — cancer cells that remain after treatment is completed are called minimal residual disease (MRD). Detection of MRD may indicate a higher likelihood of recurrence.
• Monitor remission or progression — if a cancer is in remission, frequent tests may help detect the cancer if it returns and/or determine whether it is progressing
• Screen at-risk individuals — identifying biomarker levels in blood, or abnormalities in cells or the DNA of cells of asymptomatic (healthy) individuals may indicate an increased risk (although not a certainty) of developing disease

Our facilities are fully compliant with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).