Deoxyribonucleic acid (DNA) typing kit cleared in US
This article was originally published in Clinica
Executive Summary
Gen Trak (US) has received FDA clearance to market the CQuentials DR DNA typing kit for bone marrow and solid organ transplants. The first such product cleared for IVD use in the US, the PCR-based test is used for typing alleles in genes. Single-base mismatches are detected by using sequence-specific probes covalently bound to a microtitre tray. The patient sample is tested by amplifying the DNA and matching with the bound probe.