The National Institute of Standards and Technology (NIST) and the National Cancer Institute (NCI) of the National Institutes of Health have begun a program to develop measurement assessment materials needed to evaluate and assess advanced proteomic technologies, such as mass spectrometry, that will play a large role in the discovery and validation of cancer-related proteins found in readily accessible body fluids.
The discovery that the appearance of specific proteins (or changes in the structure or concentration of a protein) in body fluids could be associated with the presence of particular cancers goes back to the 19th century, but actually identifying and validating these proteins has been difficult. Humans are estimated to have roughly 400,000 different proteins, with the specifics constantly changing with age, health and environment. In the 159 years since the discovery of the first protein cancer biomarker, only nine proteins have been approved by the Food and Drug Administration as diagnostic markers for cancer.
The rapidly developing field of proteomics—the large-scale study of proteins and their interactions through methods such as multidimensional separations, mass spectrometry and protein arrays—could significantly advance the search for novel cancer-related proteins. However, there is a shortage of rigorous measurement quality assurance tools for proteomics to ensure reliable and reproducible research results. NCI has begun a $104 million, 5-year program called the Clinical Proteomic Technology Initiative for Cancer to refine and standardize proteomic technologies, reagents and methods to establish the measurement technology needed to validate protein discoveries and move these technologies into a clinical setting.
Under an agreement finalized on May 5, NIST will develop a measurement assessment material composed of proteins mimicking the complexity and dynamic range of the human plasma proteome. The mixtures will be used as references by the network of research centers organized by the NCI to evaluate existing proteomic technologies and develop new ones. NIST also will assist in the overall study design and, as research progresses, develop more advanced proteomic reference materials. Examples may include well-characterized human plasma and other clinical specimens, standard test data sets and a mass spectra library of peptides from human plasma proteins.