Biomarkers Seeing Increased, But Not Routine, use in Cancer Diagnostics, finds Kalorama Information

NEW YORK, NY, September 12, 2010 (Press-News.org) New biomarkers for cancer detection are emerging using several different approaches, and many of these technologies are still in the early phases of development according to a diagnostics industry market research report from Kalorama Information. They can play an important role in detecting early forms of disease, in monitoring a patient's disease and in response to therapy. However, biomarkers have a long way to go before they are routinely applied in clinical settings. Still, Kalorama believes they will be one of many factors that will drive growth in cancer diagnostics. The following are examples of biomarkers being researched for use in cancer diagnostics:

• Caveolin-1 - The absence of stromal caveolin-1 has been associated with advanced tumor stage, early recurrence and metastasis of prostate and breast cancer.

• Cotinine/NNAL - Research has found that smokers with the highest urine levels of the tobacco metabolites: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) and cotinine in their urine were 8.5 times more likely to develop the lung cancer. The researchers anticipate that the test could be used to motivate people to stop smoking.

• Exosomes - Exosomes are small microvesicles precipitously shed by all solid tumors into blood. They contain virtually the entire cancer tumor transcriptome.

• Fibricytes - Fibricytes are normal blood cells that play a role in healing wounds. They may also be cell promoters that help prepare distant tissue to accept metastasis.

• Histones - Histone modification patterns appear to have broad potential uses in the development of cancer prognostic assays including response predictions to therapeutics as well as research tools and reagents.

• Midkine - Blood midkine levels are greatly elevated in the early stages of cancer formation and poor prognosis for patients has also been closely linked to high midkine levels in a number of cancers.

• Phosphorylation - Determination of protein phosphorylation in blood or biopsied tissue specimens might replace biopsies for cancer diagnosis and response to treatment.

• STAT3 - The STAT3 protein has been found to play a major role in the change of normal cells into cancerous cells. STAT3, which has a role in the cell nucleus regulating gene expression.

According to the report, a number of groups are working on the scientific and utilization foundations for new biomarker commercialization. In April 2007, the American Association for Cancer Research (AACR), the Food and Drug Administration (FDA), and the National Cancer Institute (NCI) formed a collaboration aimed at creating a regulatory pathway for biomarkers that establishes guidelines for taking biomarkers from the research phase through the FDA approval process and then on to use in clinical laboratories. The Cancer Biomarkers Collaborative (CBC) is focused on developing recommendations on assay validation and bioinformatics that would integrate biomarkers into drug development and clinical trials. This initiative is expected to provide the standardization needed for the use of new biomarkers in the clinical lab. More about biomarkers and their future use in cancer diagnostics can be found in Kalorama Information's "The Worldwide Market for Cancer Diagnostics, 4th Edition" (http://www.kaloramainformation.com/Worldwide-Cancer-Diagnostics-2504623/).

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