C2N DIAGNOSTICS LLC — Department of Health and Human Services SBIR Phase I: NIA

Description

PROJECT SUMMARY ABSTRACT For a long timethe study of Alzheimer s diseaseADin humans has been hampered by the fact that absolute AD diagnosis could only be ascertained by assessment of brain pathology upon autopsyMore recentlyimaging agents have become available that allow direct imaging of the two hallmarks of ADamyloid plaques and tau tanglesin living humansHoweverthese imaging agents are expensive and invasive for use in routine diagnosticsThe need for low cost blood based diagnostic assays has never been greaterC N Diagnostics has been developing mass spectrometry based assays that investigate amyloid beta peptides in biofluids sinceRecent advances in sample cleanuppurification of amyloid betaand mass spectrometry instrumentation have made it possible to reliably quantify amyloid beta in human plasma samplesPreliminary data from DrRandall Bateman s laboratory at Washington University shows that the ratio of two amyloid beta peptides in plasma can predict the presence of amyloid plaques in the brainThis technology could revolutionize the field of AD diagnosticsand when presented at the Alzheimer s Association International Conference in Julythis discovery was pronounced asby far the biggest news of the meetingby one of the key opinion leaders in AD clinical researchThe specific aims of this SBIR Fast Track application are to analytically and clinically validate C N s plasma assay for use as a diagnostic test for predicting brain amyloidosis NARRATIVE C N Diagnostics seeks to commercialize a blood test for detection of Alzheimer s disease brain pathologyAmyloid plaques accumulate in the brain early in the progression of Alzheimer s diseaseand C N has preliminary data showing that measurement of proteins in blood can predict the presence of these plaques in the brain