Abstract:
A method for the discovery, development and clinical application of multidimensional multiplex synthetic biomarker assays based on patterns of cellular response.After stimulation or inhibition, a selected multiplicity of cell types are assayed for a multiplicity of cellular or molecular responses, and known machine learning techniques are used to synthesize the cellular responses into an optimized clinical biomarker. The computationally derived algorithm includes the relationships within and between the component steps so as to produce an optimized synthetic clinical biomarker. During discover of the assay one or more of the component steps are repeated iteratively until a final clinically optimized algorithm is produced.Such a multidimensional multiplex cell response assay may provide improved diagnostic performance with respect to entities such as immune status, infection, and antibiotic and vaccine efficacy, among others.
Abstract:
A method for deriving a multiplex cell response assay (MCRA), the method comprising: obtaining at least one specimen that has been phenotyped and classified with respect to the disease of interest using existing diagnostic techniques; adding of at least one stimulatory or inhibitory agent; isolating or separating at least one cell type; performing a multiplex measurement of cellular responses in each of the at least one cell type; and computationally deriving a clinically useful biomarker algorithm.
Abstract:
A method for determining multiplex biomarker algorithms based on optical, physical and/or electromagnetic patterns, and applying the multiplex biomarker algorithms so as to provide a single diagnostic result indicative of a medical condition, the method comprising: measuring multiple physical, electromagnetic or optical patterns in the setting of experimentally induced or clinically occurring disease using at least one of physical, electromagnetic and optical sensors; using known mathematical or machine learning algorithms to compile the measured parameters, or their signal transformed versions, into a uniplex scale or index using a clinical classifier, such that the uniplex scale or index has better clinical performance in identifying a medical condition than any of the input parameters individually; optimizing the algorithm iteratively using additional clinical data sets and inputting patient characteristics and laboratory derived measurements; using the uniplex scale or index to identify a medical condition; and displaying to a user the single diagnostic result indicative of a medical condition.