– New in-vitro diagnostic kits help patients fight cancer in
the EU –
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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