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Invitae Garners CE-IVD Mark for Two Comprehensive Genomic Profiling Tests

NEW YORK – Invitae on Wednesday said it has garnered CE-IVD marking for its FusionPlex Dx and LiquidPlex Dx genomic profiling panels and is now launching these tests in European markets.

FusionPlex Dx is a 41-gene panel that analyzes formalin-fixed, paraffin-embedded tumor samples and detects structural variants, including fusions, in RNA. The test can help guide treatment decisions for patients with solid tumors and is specifically intended to be used as a companion diagnostic to identify targeted treatment opportunities for non-small cell lung cancer patients who harbor MET exon 14 skipping alterations, and ALK, ROS1, RET, and NTRK fusions.

LiquidPlex Dx is a 29-gene liquid biopsy test that gauges indels in cell-free circulating tumor DNA. This test can also guide treatment decisions for patients with solid tumors and can be specifically used as a CDx to identify target treatment opportunities for NSCLC patients with MET exon 14 skipping alterations.

Both panels came to Invitae through its acquisition of ArcherDx in 2020 and can be adopted within European facilities with sequencing capabilities. Both tests use Illumina's next-generation sequencing platforms.

"This is a major step toward our mission to bring comprehensive genetic information into mainstream medicine," Vishal Sikri, Invitae's president of oncology, said in a statement. "[These] tests will enable more patients access to the right cancer therapies at the right time, which is especially critical in Europe where the majority of molecular testing is performed locally in decentralized hospital settings."