www.fdanews.com/articles/206692-invitae-gets-ce-ivd-mark-for-its-cancer-testing-kits
Invitae Gets CE-IVD Mark for Its Cancer Testing Kits
February 23, 2022
Medical genetics company Invitae has received a CE-IVD mark for its FusionPlex Dx and LiquidPlex Dx molecular tests for nonsmall-cell lung cancer.
FusionPlex Dx provides genomic profiling for patients with solid malignant growths while LiquidPlex Dx can identify circulating tumor DNA from a liquid biopsy, to identify patients who may benefit from a targeted therapy.
The panels are intended to be used on Illumina's next-generation sequencing platforms for in-vitro diagnostic testing. The company expects the diagnostic tests to be in high demand in Europe, where most of the molecular testing is performed in decentralized hospital settings.