Clinical Trial Assay
A Clinical Trial Assay is designed according to Insight Genetics’ strict Quality Standards, outfitted with enhanced controls, and subsequently validated under CLIA guidelines. These assays are generally a larger investment than Research Assays. However, they are appropriate for robust prospective or retrospective analysis of either Phase I or Phase II data. Clinical Trial Assays are run within our CLIA certified laboratory, Insight Molecular Labs, or manufactured and commercialized as a set of products through our partnerships with contract manufacturers as a Research Use Only (RUO) assay.
Mature assays, including Clinical Trial Assays and Companion Diagnostics, require additional components such as working with regulatory firms to ensure a smoother regulatory path from pre-submission through Pre-Market Approval (PMA).