Abstract
Biomarkers are fundamental to nearly every step in the drug discovery and development process, from target validation in the laboratory, to patient stratification in the clinic. Recently, genomic discovery tools have had success in this area, but MS-based proteomic methods less so. This is due to difficulties in developing high throughput assays (ELISA, etc.) for triaging biomarker candidates against large clinical sample collections. However, the SomaLogic proteomics platform is ideally suited to this task. At the heart of the detection technology are SOMAmers (Slow Off-rate Modified Aptamers). They are modified DNA aptamers with high affinity (10∧–9 to 10∧–12 M) and high specificity for their cognate analytes. The assay is highly multiplexed, quantifying >1100 proteins simultaneously from a single 65 uL sample. Sensitivity of the array is generally comparable to sandwich ELISA performance (median LLOQ 100 fM, LoD 40 fM). Samples from a wide variety of sources are amenable to analysis – from serum to CSF, cell/tumor extracts, synovial fluid, etc. Biomarker signatures can be defined in as little as 5 weeks and clinically actionable diagnostics in as little as 6 months. We are currently engaged in a number of clinical discovery applications (Phase 0–4) and have a large number of additional studies completed, in design or sample accrual. The technology and these applications will be discussed.