ProteoSep® 2D Microarrays 

A “Bedside to Bench” Clinical Biomarker Discovery Technology

The Problem:

The discovery of “clinically meaningful” biomarkers for any particular disease is one of the most important goals for optimum management of a patient from diagnosis to care and treatment. Ideally these biomarkers are best identified and measured from blood, urine, saliva and the like because they are the least invasive samples to obtain from patients. While it is rather easy to obtain high quality samples with good clinical information about the patient from which they were obtained, how to actually find and validate meaningful markers in these extraordinarily complex samples has proven far from easy or cost effective. It is the reason for the explosion of the "Omics" field of technologies.

The Promigen Solution:

To overcome this complexity hurdle, Promigen Life Sciences has developed a novel ProteoSep® 2D Protein Microarray concept that uses a patient's own protein "signature" as the means to mine for new markers.  The approach is based on the established notion that surveying a patient’s humoral response (autoantibody profile) can serve as a sentinel for over- or under-expression of proteins particular to a disease state and its expression. 

To accomplish this we take a large complex "Haystack" of proteins (cell line,  tissue sample or biofluid) containing "Needles" (protein biomarkers) of interest and, using our 2D ProteoSep liquid separation technique, orthogonally separate them into hundreds of smaller liquid fractions [mini-haystacks]. These liquid fractions are then used to prepare hundreds of identical protein microarrays to miniaturize detection of the "needles" using known antibodies or autoantibody response from patient serum or plasma samples.  This lends to far more efficient use of valuable patient samples as well as miniaturizing the whole serological assay process. Using this 2D microarray approach gives researchers the ability to survey very large populations of well-defined patient cohorts rapidly and much more cost effectively.

 

Comparing the humoral response profiles (autoantibody signatures) of well-defined patient cohorts with the disease to those without the disease [controls, benign disease, etc.] and then determining which liquid fractions truly separates the patients into their respective cohort class, identifies those that truly contain protein markers of clinical interest. Further analysis of these particular liquid fractions will provide the identity of clinically relevant biomarkers sought after. This approach now has the patients themselves telling us where to look for important disease and disease progression markers. Patients (Bedside) now inform researchers (Bench) of potentially better, more clinically relevant markers because they have already been vetted by the patients themselves at the outset. 

The Benefit:

The unique features this “Bedside-to-Bench” approach offer, and the efficiencies it will introduce in both time and cost savings, will have a significant impact on how biomarker and drug discovery research as well as clinical trials are performed in the future. Moreover, if the same process can be used in both drug development efforts and monitoring of patients before, during and after the drug treatment, it will save enormous amounts of time, effort and money in drug and biomarker development as well as validation costs.  It would also serve as a significant aid to clinicians dealing with patients throughout the course of diagnosis and treatment.

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