AM BIOTECHNOLOGIES, LLC — Department of Health and Human Services SBIR Phase I: 400

Description

ABSTRACTReflecting a particular physiological statebiomarkers are very important for earlier diagnosis of diseasesrealizing personalized medicineas well as facilitating drug development and discoveryFor these reasonssignificant research efforts are currently being directed towards biomarker discovery and transitioning them into clinical useAM Biotech is developing a new discovery proteomics platform calledUnified Process for Discovering Protein Biomarkers and their X AptamersUnified ProcessThis technology is a unique proteomics tool created from the combination of AM Biotechandapos s bead based X Aptamer selection platformmulticolor flow cytometryand liquid chromatography tandem mass spectrometryThis Unified Process is highly attractive in that it allows for multiplexingdetection of low abundance differences and relatively quick and efficient processingHowevermost importantlyit integrates the major stages of the protein biomarker pipelinediscoverysometimes separated into candidate identification and prioritizationverificationandclinical validation into a more efficient pipelineUnlike typical protein biomarker discovery techniques such asshotgunproteomics andDD gels coupled with MSwhich includes difference gel electrophoresisDIGEthe Unified Process identifies an X AptamerXAaffinity reagent for every candidate biomarkerThe availability of an affinity reagent to each candidate biomarker from the earliest stage of discovery is transformative to the pipeline because there are no assays for the vast majority of human proteins and such assays must be developed de novoThe XAsselected against native proteins in their native environment enable multiplexed downstream assaysprotein concentration from samples for more precise identification of the candidates using MSand the ability to quickly develop an affinity enrichment multiple reaction monitoring MS assayAEMRM MSThe Unified Process consists of four key stepsand of thesethe most important of which is the initial flow cytometry analysis of beads bound to differentially labeled proteomesTo dateAM Biotech has established flow cytometry conditions that will allow differences between two proteomes labeled with different fluorophores to be analyzedIn this applicationan optimizedcolor process will be developedThis will require several inter related variables to be studiedOnce conditions forcolor sorting are establishedspiking experiments will be used to characterize the performance of the processSuccessful completion of the specific aims will pave the way for a Phase II investigation to integrateoptimize and fully characterize the remaining steps of the Unified Process and to use the process to analyze patient plasma samples NARRATIVE Biomarkers potentially have a greater ability to reduce healthcare costs than any other current medical research areaAs a resultthere have been more thanpublished articles pertaining to biomarker discoveryUnfortunatelythis research has resulted in fewer than one hundred biomarkers validated for routine clinical useAM Biotechandapos s new proteomics technology will make biomarker discovery more efficientlower the costsand enable faster translation of biomarkers into clinical use