Intrinsic Bioprobes Inc. ("IBI") today announced the launch of its first mass spectrometry-based protein assays for in-vitro diagnostic testing. The assays for beta-2-microglobulin, cystatin C, and retinol binding protein are performed on IBI's MASSAY® platform at the CLIA-certified and College of American Pathology (CAP) accredited diagnostic laboratory of the Institute of Genomics Medicine, UMDNJ-New Jersey Medical School.
"The assays are based on IBI's proprietary Mass Spectrometric Immunoassay (MSIA™) technology that in addition to quantification, provides a unique insight into the structural heterogeneity of each protein biomarker," says Dobrin Nedelkov, Ph.D., the CEO and Scientific Director of Intrinsic Bioprobes. The three target proteins - beta-2-microglobulin, cystatin C, and retinol binding protein - are FDA approved clinical markers for in-vitro diagnosis of kidney disease and renal failure. However, all three proteins exhibit structural microheterogeneity that gives rise to protein variants that are not detected by conventional tests. "With these new assays, clinical studies can be initiated to delineate the importance of structural variants in the onset and progression of disease," adds Nedelkov. "We are pleased that we can offer the quality and reproducibility of centralized testing and certify that the assays are performed to the rigorous standards established by CLIA."
"We are excited to perform these assays at our molecular diagnostics laboratory," says Peter Tolias, Ph.D., Professor and Executive Director of the Institute for Genomics Medicine ("IGM"). The Institute is dedicated to biomarker discovery and the clinical evaluation of biomarkers and operates research, development, as well as CLIA-certified CAP-accredited clinical diagnostic testing laboratories. "We have substantial access to patients through our affiliated hospitals and clinics and are interested in undertaking a clinical trial to evaluate structural heterogeneity within these three clinical markers in patients with renal dysfunction," adds Tolias.
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