Mayo Clinic inked a deal with Rheonix to assess the performance of the company’s genotyping test for warfarin sensitivity in clinical and research settings. The test will be available for all Mayo Clinic patients and will be offered through the clinic’s reference laboratory, Mayo Medical Laboratories, to clients throughout the world.
The cost and expertise required to perform currently approved warfarin-sensitivity tests has prevented routine use, according to the collaborators. Rheonix is developing a rapid, fully integrated, and automated genotyping test for individualized dosing of Warfarin based on its Rheonix CARD (chemical and reagent device) system. It is designed to detect genotypes related to 2C9*2, 2C9*3, and VKORC1 from a raw buccal swab.
EDTA anticoagulated whole blood is transferred to proprietary transport media that can be either stored at room temperature or immediately applied to the Rheonix CARD. Once applied to the Rheonix CARD, the following required steps are automatically performed without intervention by an analyst: cell lysis, DNA purification, PCR amplification, denaturation, annealing of amplicons to filter-linked primer extension probes, primer extension in the presence of biotintylated dUTP, incubation with streptavidin-coupled HRP, and color detection. Only an exact match between the immobilized primer-probe and the amplicon template will allow an extended product to be generated.