Astute Medical takes an innovative approach to biomarker development.
Traditional biomarker discovery programs often begin with a lead-candidate biomarker, then assays are developed and the search for a clinical application begins—often with limited success.
The Astute approach is to, first and foremost, identify the unmet clinical need. We then begin work to find the solution and the biomarkers that will meet these criteria. Our process yields a detailed understanding of key clinical variables including epidemiology, patient care outcomes and economic ramifications for health care. We employ a systems biology approach which integrates information from pathway analysis, proteomics and genomics, and then tailor internally developed pilot clinical studies to include the patient population that most accurately represents clinical practice. The samples obtained in these studies permit early identification of the best-performing target biomarkers. Using a proprietary computational analysis, we optimize the selection of individual novel biomarkers and performance of biomarker panels. Larger multisite validation studies are used to confirm and extend the pilot results. The test is then launched on a bench-top analyzer—the Astute140® Meter.