Invitae Launches its First CE-IVD Cancer Testing Kits In Europe
Invitae (NYSE: NVTA) announced the launch of its first CE-IVD cancer testing kits, FusionPlex Dx® and LiquidPlex Dx™, in Europe on February 16, 2022. These in-vitro diagnostic products are designed to enhance precision oncology, enabling pathologists and oncologists to deliver key information for cancer therapy efficiently. The tests support comprehensive genomic profiling for non-small cell lung cancer (NSCLC) and are compatible with Illumina's Next Generation Sequencing platforms. This initiative aims to make genomic testing more accessible in decentralized hospital settings across Europe.
- Launch of FusionPlex Dx and LiquidPlex Dx expands product offerings in the European market.
- Tests align with ESMO guidelines for NSCLC, enhancing their credibility and applicability.
- Collaboration with Illumina strengthens market position and technology capabilities.
- The company has a history of losses, which may hinder future growth and stability.
- Dependence on rapid changes in genetic data may pose challenges in test result accuracy.
SAN FRANCISCO, Feb. 16, 2022 /PRNewswire/ -- 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."
About Invitae
Invitae Corporation (NYSE: NVTA) is a leading medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time and lower prices. For more information, visit the company's website at invitae.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the availability, features and potential impact of the company's products; the company's belief that its tests will enable more patients access to the right therapies at the right time; and the company's beliefs regarding the shift towards precision oncology and the importance of genomic testing. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company's history of losses; the company's ability to compete; the company's failure to manage growth effectively; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.
Contact:
pr@invitae.com
(628) 213-3283
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