Machaon Diagnostics is a preferred laboratory partner to pharmaceutical firms conducting clinical trials in the areas of thrombosis, hemostasis, nephology and rare disease. We offer both CAP/CLIA and GLP testing and regulatory-compliant method validation solutions for submission to the FDA and other regulatory bodies. Machaon Diagnostics has emerged as a leading laboratory for complement gene sequencing and other testing, due to our rapid turnaround and expedited study capabilities. Machaon was founded in 2003.
Kypha is a clinical diagnostic company driven by the need for reliable and accessible diagnostic testing for immune system activation, particularly surrounding the complement system. Since its founding in 2010, Kypha’s comprehensive complement activation diagnostics program has focused on sample workflows in various clinical settings in order to reduce sample management requirements and preanalytical variability. Kypha took another step in this direction with the acquisition of Biosensia and its proprietary next generation diagnostic platform, RapiPlex, designed for low complexity, CLIA-waived protocols and multiplex assay formats for disease specific testing panels. Biosensia also brings custom assay development expertise, regulatory support, and ISO13485-certified diagnostics manufacturing services with a track record of delivering custom assays for infectious disease, autoimmunity, cancer, allergy, and drugs of abuse with support for regulatory filings.