Invitae announces availability of two IVD oncology products

Invitae, a medical genetics company, has announced the availability of FusionPlex Dx and LiquidPlex Dx in Europe, part of its Anchored Multiplex PCR chemistry in-vitro diagnostic (IVD) products. Invitae specialises in innovation for precision oncology in the fight against cancer.

Vishal Sikri, president of oncology at Invitae, said: "This is a major step toward our mission to bring comprehensive genetic information into mainstream medicine. Our best-in-class FusionPlex and LiquidPlex 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 decentralised hospital settings."

In line with ESMO guidelines for non-small cell lung cancer (NSCLC), Invitae's FusionPlex Dx and LiquidPlex Dx allow comprehensive genomic profiling (CGP) and companion diagnostic (CDx) use for solid tumour neoplasms including NSCLC in tissue biopsy and where tissue is a limiting factor. The panels are intended to be used on Illumina's Next Generation Sequencing (NGS) platforms for IVD testing.

Joydeep Goswami, chief strategy and corporate development officer at Illumina, said: "Increasing patient access to content on our instrument fleet through partnerships such as those with Invitae speaks to our mission to improve human health by unlocking the power of the genome. We congratulate Invitae on its first CE-IVD cancer testing kits, a significant milestone."

FusionPlex Dx identifies structural variants including fusions in RNA derived from formalin-fixed, paraffin-embedded tumour specimens. FusionPlex Dx covers multiple actionable variants in a 41-gene panel to provide CGP for patients with solid malignant neoplasms. FusionPlex Dx is intended to be used as a CDx to aid in identifying patients diagnosed with NSCLC with mesenchymal-epithelial transition factor (MET) exon 14 (METex14) skipping alterations, anaplastic lymphoma kinase (ALK) fusions, ros proto-oncogene 1, receptor tyrosine kinase (ROS1) fusions, ret proto-oncogene (RET) fusions, neurotrophic receptor tyrosine kinase 1-3 (NTRK1, NTRK2, NTRK3) fusions, and for whom treatment with a targeted therapy may be beneficial.

LiquidPlex Dx identifies substitutions and insertion-deletion mutations in cell-free circulating tumour DNA (ctDNA) isolated from plasma derived from whole blood of cancer patients (liquid biopsy). LiquidPlex Dx interrogates 29 genes to provide CGP for patients with solid malignant neoplasms. LiquidPlex Dx is intended to be used as a CDx to aid in identifying patients diagnosed with NSCLC with METex14 skipping alterations, and for whom treatment with a targeted therapy may be beneficial.

Sikri added: "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. Yet globally, access to the exponentially increasing therapy options is not guaranteed."