This is a renewal application for the University of Maryland Baltimore Biomarker Reference Laboratory (UMB BRL). Over the last 5 years the UMB BRL and the PI, Sanford Stass, MD, have been very active collaborating and supporting the Early Detection Research Network (EDRN) and the PI has participated on several EDRN committees. The UMB BRL has provided resources in support for analytical and clinical validation of biomarkers, development of assays and technologies, and standardization of assay methods in collaboration with multiple investigators in the EDRN. The UMB BRL is organized to include a team of directors/co-investigators with broad knowledge, experience, expertise and provides a wide range of core pathology laboratories with CLIA/CAP accreditation including immunohistochemistry, clinical chemistry, molecular diagnostics, flow cytometry, cytogenetics, and a CLI/VCAP, GLP compliant histopathology laboratory. There are also core laboratories including biopolymer genomics, proteomics, tissue bank (tissue microarrays and immunohistochemistry) and biostatistics. Within the UMB BRL there is a developmental study with the objective to develop diagnostic micro-RNA assays and a micro-RNA biomarker panel in sputum for the early detection of non-small-cell lung cancer. We have found that 26 miRNA genes were differentially present between NSCLC tissues and normal tissues. There are 3 specific aims: 1) develop and standardize a real time reverse transcriptase PCR assay to measure multiple miRNAs in sputum, 2) optimize a panel of sputum miRNA markers and 3) validate the miRNA panel for early detection of lung cancer. This study should provide a profound impact for early detection of NSCLC. The UMB BRL leverages the EDRN experience of the investigators and considerable expertise of the leadership to provide flexible support for standardized procedures, high throughput, robust assays, clinical translation, design and conduct analytical validation studies, a variety of laboratory and platform assays, GLP compliance, and adherence to regulatory requirements including CLIA/CAP, FDA, AABB etc. Numerous collaborations are within and outside UMB guaranteeing maximum responsiveness to the EDRN. Lines of authority and organizational structure have been established in the UMB BRL to ensure timely performance, efficient communication and rapid translation of findings from the development phase into clinical application
The UMB BRL has extensive experience in various laboratory technology and testing. This experience includes translation of biomarkers from a research setting into direct clinical laboratory testing in a stringent environment as required by regulatory agencies including federal and state to assure quality testing for patients. A study for early detection of non-small-cell lung cancer will help improve prognosis/survival.
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