Fast MDx was delighted to read an excellent article in Genome Web by Justin Petrone, that explains how the platform is being validated by Public Health Wales, which will complete Fast MDx’s UKCA and CE-IVDr regulatory approvals program.

The article explains that the Fast MDx platform will be open and so pathology labs can use both Laboratory Developed Tests (LDTs), as well as assays from independent assay manufacturers. These assays will be sold directly to the labs by the assay manufacturers, and will enable for the first time, independent assay manufacturers, who don’t sell instrumentation, to sell their assays for use on a high-throughput automated platform.