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Invitae Launches its First CE-IVD Cancer Testing Kits In Europe

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Invitae Launches its First CE-IVD Cancer Testing Kits In Europe | Pharmtech Focus

Invitae (NYSE: NVTA), a leading medical genetics company, today announced the availability of FusionPlex Dx® and LiquidPlex Dx in Europe, part of its industry-leading Anchored Multiplex PCR chemistry in-vitro diagnostic (IVD) products. Invitae is delivering essential high quality innovation for precision oncology in the fight against cancer.

With this announcement, Invitae provides the highest quality CE-IVD products to enable European pathologists and oncologists to efficiently provide vital information, in a timely manner, to guide cancer therapy for patients.

“This is a major step toward our mission to bring comprehensive genetic information into mainstream medicine,” said Vishal Sikri, President of Oncology at Invitae. “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 decentralized 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 tumor 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.

“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,” said Joydeep Goswami, Chief Strategy and Corporate Development Officer at Illumina. “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 tumor 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 tumor 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.

“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 tumors using tissue or blood samples for therapy selection,” said Sikri. “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.”

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