The objectives of Phase II are to develop, validate, and commercialize a tool for detecting genotypes affecting patient care and safety during the perioperative interval (before, during, and immediately following surgery). Despite publications describing genetic risk factors, genetic screening is not performed before surgery. There is a need and a sizeable potential market for a method to prevent adverse clinical outcomes in surgery patients. This proposal addresses this need by expanding on Phase I to develop a cost-effective system to analyze genomic DNA from blood. This approach relies on the Invader assay, a method for detecting defined genetic variations without PCR. An innovation in Phase II is the """"""""biplex"""""""" Invader format allowing simultaneous detection of wild-type and mutant alleles in one well.
Our specific aims i nvolve: (1) genotyping 1,200 patient samples from 3 medical centers for 100 alleles using conventional methods; (2) developing biplex Invader assays for the new alleles; (3) formatting the assays for manual and automated analysis; and (4) validating them on patient samples. Successful completion of Phase II will result in a cost-effective panel suitable for point-of-care genotyping and has the potential to engender other innovative uses of genetic information.
