Founded in 1982 in County Antrim, Northern Ireland, Randox Biosciences is a leading manufacturer of in vitro diagnostics. Their over 3300 employees include nearly 1600 R&D scientists and engineers. They particularly made a name for themselves during the COVID-19 pandemic as the developer of rapid diagnostic tool for SARS-CoV-2 infection. Along with this, they supply 12% of the world’s cholesterol tests, and 5% of the world’s diseases and conditions are diagnosed with Randox products.
The company has been developing multiplexing technologies for over 20 years. Randox’s proprietary Biochip Array technology makes use of a chemically activated 9x9mm ceramic chip. This chip can multiplex up to 49 discrete test regions for immunoassay in a 7x7 array, or 100 test regions for molecular assays in a 10x10 array. The technology can be used for fully quantitative assays, diagnostics, and research.
However, proteomics research requires further multiplexing still, which prompted Randox to scale up their number of discovery panels. With panels in the order of thousands, they can investigate hundreds of promising biomarkers at a time. To do so, Randox partnered with Olink Proteomics, utilizing their high-throughput technology that allows for extensive biomarker testing with good sensitivity and specificity.
Randox participates in Olink's concordance testing, a unique proficiency testing method for proteomics that ensures lab accuracy and facilitates validation processes. This involves the split sample analysis of 50 samples between the Olink reference lab in Uppsala and the Randox lab. The test assesses the performance between the site in terms of detectability, CV, correlation, and regression.
The presentation outlines the critical steps from biomarker identification to clinical trial assays (CTAs) and the importance of optimisation and validation in developing a companion diagnostic (CDx). Huguent stressed the need for early decisions on assay components and validation processes to transition from research use assays to commercial IVDs.
The presentation discusses the necessity of regulatory registration, and the logistics involved in ensuring assays are available for diagnostics across various countries. Randox offers support in market awareness and education to facilitate the commercialization of developed assays.
