Thursday, January 19, 2006

Biomarkers – Lab Testing in the Next Generation

According to the Biotech dictionary a Biomarker is a “pharmacological or physiological measurement which is used to predict a toxic event in an animal.” Typing “Biomarker definition” into Google provides a host of associated definitions. Biomarkers are part of the new health model based on the human genome which provides predictive, preventive health care by searching for molecular signs of infectious agents or environmental toxins, or defective genes.

Biomarkers have application in disease management and modification. For example biomarkers drawn from a simple blood test for amniocentesis would eliminate the invasive procedure currently used. Cancer therapy could be greatly enhanced with biomarkers.

According to the LabSoft News Blog, biomarkers are different from analytes which detect chemicals in the blood stream in that biomarkers correlate to a particular perturbation of a biological system. The blog goes on to discuss how biomarkers are typically used in followup cases of conditions such as cancer rather than in prediction or screening for those conditions. In another post at this site, the blog predicts biomarkers will bring differentiation to a lab’s test offering and thus, increased revenue streams.

As an emerging technology, Biomarkers now have their own conference focused on applying biomarkers in clinical trials. The Fuji-Keizai market research report pegs the Biomarker market at $6B covering Academic, Government, Private segments.

Techniques for measuring biomarkers include DNA adducts, protein adducts, immunoaffinity chromatography and immunohistochemistry. These techniques employ chromatography/mass spectrometry (GC/MS), GC/high resolution Mass Spectrometry, fluorescence, diode array and radioactivity detection, and immunohistochemistry.

Let’s look at some of these techniques more closely. An adduct is a complex that forms when a chemical binds to a biological molecule such as DNA or protein. For example, DNA adducts are altered forms of DNA that occur from exposure to carcinogens. A DNA adduct can be repaired to return to its original state or can be turned into a mutation.

Immunoaffinity chromatography is a method of purifying plasma proteins using monoclonal antibodies.

Immunohistochemistry is the use of antibodies or antisera as histological tools for identifying patterns of antigen distribution within a tissue or an organism. An antibody (or mixture of antibodies) that binds to a specific protein or other antigen is tagged with a fluorescent chemical or an enzyme that can convert a substrate to a visible dye.

Virtual Instrumentation brings tools to support the biomarker discovery process. This team in China used LabVIEW to improve the sample flow process. Another team in China used LabVIEW to control a microfluidic system seeking Interleukin-8 (IL-8) mRNA and protein biomarkers for oral cancer. A team from the University of Basel created a liquid handling system driven by LabVIEW for biomarker discovery.

Numerous companies are working in this space. Nanosphere makes biomarkers for protein detection which they call Biobarcode. Biomarkers Inc uses biomarkers for age-related diseases. BioVisioN created a process for analyzing peptides and proteins for biomarker discovery.

The discovery of the human genome brought a new age to biological testing. The biomarker is one example of an emerging technology that is coming to fruition.

Best regards,
Hall T.

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