Clinical and Analytical Validation of Cancer Biomarkers

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DESCRIPTION (provided by applicant): This proposal is a renewal of our EDRN Biomarker Reference Laboratory (BRL) which is located within the Clinical Chemistry Division (CCD) of the Johns Hopkins Medical Laboratories (JHML) at the Johns Hopkins Medical Institutions. The BRL will continue to serve as a network resource for clinical and laboratory validation of biomarkers, which includes technological developments and assay refinement. The JHML are certified by the College of American Pathologist (CAP) and regulated by CLIA (Clinical Laboratory Improvement Amendments of 1988). As such, the JHML follow stringent, good laboratory practice (GLP) guidelines for quality control and quality assurance. The proposed developmental project will be conducted at the Center for Biomaricer Discovery (CBD), The Johns Hopkins University. The project goal is to validate glycoproteins as biomarkers for the early detection of aggressive prostate cancer using cutting edge technologies such as mass spectrometry, protein/lectin microarrays, bioinformatics, and immunoassays. We have assembled a strong team of research and clinical scientists based on many years of experience with cancer biomarkers and in technology development, study design, bioinformatics, validation, and translation. Dr. Chan, the PI, is the Director of both CCD and CBD. He has over 30 years of experience in clinical chemistry and has conducted many (> 50) research studies funded by industry on cancer diagnostics leading to the approval by the FDA for clinical use. Most recently, the first in vitro diagnostic multivariate index assay (IVDMIA) was cleared by the FDA for clinical use. This test, OVAl, was based on our original multiplex proteomic study published in Cancer Research. In addition, several leading scientists from the diagnostics industry will serve as consultants to provide expertise and facilitate the development and validation of cancer diagnostics. In this renewal, we plan to continue our strong commitment to the EDRN mission through network collaborations, and provide leadership in biomarker validation and technology/assay improvement. With this multi-disciplinary team of scientists, the BRL at Johns Hopkins offers the best opportunity for the success of cancer biomarker validation and translation into the clinic for the early detection of cancer.