Researchers have been attempting to develop noninvasive, blood-based clinical diagnostics for over 100 years. Remarkably, less than 30 new biomarkers have been approved since that time. The vast majority of these tests are relatively nonspecific or insensitive and few are effective early markers. In addition, there is growing concern that regular screening with these biomarkers may do more harm than good, since the large number of false positives translates to unnecessary therapeutic interventions that carry increased risk to the patient and increased cost to the healthcare system.
ImmunoSignature™ Technology may detect a broad range of diseases, patient stratification, and response to therapies.
Any disease that affects the immune response (autoimmune, cancer, infectious disease, metabolic and neurologic diseases) can potentially be measured using the ImmunoSignature™ Test. The basis for this unique platform is a high-density peptide array that is specially designed to query the myriad of antibodies present in a human blood sample. The fabrication of these arrays leverages equipment and processes similar to those used in the manufacturing of silicon-based electronics, making it scalable. Additional indications do not require a new product development process, rather a new algorithm.