NextGen Sciences and Expression Pathology Develop Quantitative Protein Biomarker Assay
News Apr 22, 2009
NextGen Sciences and Expression Pathology, Inc. have announced that they have a protein biomarker assay methodology that provides, for the first time, reproducible, quantitative measurement of protein expression in formalin fixed paraffin embedded (FFPE) tissue samples.
The assay methodology uses Expression Pathology’s Liquid Tissue® reagents and protocols for sample preparation and to solubilize the entire protein content from standard FFPE tissue. The solubilized proteins are then assayed by NextGen Sciences using Multiple Reaction Monitoring (MRM), a method for quantitation of proteins using mass spectrometry.
The results correlate directly with those obtained by current immunohistochemistry techniques, but the new method is faster, straightforward, and provides accurate and quantitative measurement of protein biomarkers.
The companies began collaborating in June 2008, and have demonstrated the utility of the FFPE MRM assay methodology by measurement of the Her2 protein, which has become an important marker for breast cancer diagnosis and therapy.
Formalin fixation of tissue samples which are subsequently embedded in paraffin is the gold standard for biopsy and surgical tissue preservation. However, proteins within the tissue samples are heavily cross-linked as a result of the formalin fixation and therefore, until now, options for analyzing them have been limited.
“The development of this assay shows that FFPE tissue can be used for direct measurement of clinically important protein biomarkers by mass-spectrometry-based protocols,” said Michael Pisano, CEO, NextGen Sciences. “As MRM assays can be multiplexed, we have the potential to develop assays where multiple proteins are measured simultaneously, for example cancer therapy targets or cell signalling pathway proteins.”
Peter Tunon, Vice President Sales and Marketing, Expression Pathology, commented: “Her2 is the prototype diagnostic, prognostic and therapeutic target for the personalized medicine approach to disease treatment. Precise quantitation of such protein biomarkers in FFPE tissue will have a major impact on the advancement of personalized medicine.”