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February 17, 2022

Invitae introduces two IVD test kits for cancer in Europe

FusionPlex Dx covers several variants in a 41-gene panel to offer CGP for solid malignant neoplasms patients.

Genetic testing company Invitae has launched two in-vitro diagnostic (IVD) cancer testing kits, FusionPlex Dx and LiquidPlex Dx, in Europe.

The two tests, which have both received the CE Mark, allow comprehensive genomic profiling (CGP) and companion diagnostic (CDx) use for solid tumour neoplasms that include non-small cell lung cancer (NSCLC) in tissue biopsy.

For IVD testing, the panels are designed for use on Illumina’s next-generation sequencing (NGS) platforms.

FusionPlex Dx is designed for the detection of structural variants, including fusions in RNA that are derived from formalin-fixed, paraffin-embedded tumour specimens.

It covers several variants in a 41-gene panel to offer CGP for solid malignant neoplasms patients.

To be used as a CDx, the test supports the identification of NSCLC patients with mesenchymal-epithelial transition factor (MET) exon 14 (METex14) skipping alterations, receptor tyrosine kinase (ROS1) fusions and ros proto-oncogene 1.

Furthermore, it helps to identify individuals with anaplastic lymphoma kinase (ALK) fusions, ret proto-oncogene (RET) fusions and neurotrophic receptor tyrosine kinase 1-3 (NTRK1, NTRK2, NTRK3) fusions, as well as people who could benefit from targeted therapy.

LiquidPlex Dx is intended for the detection of insertion-deletion mutations and substitutions in cell-free circulating tumour DNA (ctDNA) isolated from plasma taken from the liquid biopsies of cancer patients.

It offers CGP that examines 29 genes for solid malignant neoplasms patients.

As a CDx, the test helps identify NSCLC patients with METex14 skipping alterations, as well as people for whom targeted therapies may be beneficial.

Invitae Oncology president Vishal Sikri said: “With Invitae’s simplified workflow and reporting solutions, both tests will enable any facility with sequencing technology, combined with our solutions, to accurately profile solid tumours using tissue or blood samples for therapy selection.

“Precision medicine has increasingly delivered better outcomes for many cancer patients over the last several years.

“Molecular pathology has never been more important as the fight against cancer shifts towards precision oncology and targeted therapies based on genomic testing.”

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