– Personalized tumor-informed assay helps
patients get ahead of cancer –
SAN
FRANCISCO, March 17, 2022 /PRNewswire/ -- Invitae
(NYSE: NVTA), a leading medical genetics company, today announced
full access to its Personalized Cancer Monitoring
(PCMTM) platform to help detect minimal or molecular
residual disease (MRD) in patients with solid tumors. Invitae PCM
uses a novel set of personalized assays based on a patient's tumor
to detect circulating tumor DNA (ctDNA) in blood, offering the
ability to perform risk stratification, response assessment to
treatment and detection of cancer recurrence, based on recent
studies.
"Relapse risk stratification is a clinical need for many
patients undergoing treatment for solid tumors and is best served
by up-to-date molecular tools to complement and improve upon the
standard of care methods for recurrence detection," said
Robert Nussbaum, M.D., chief medical
officer, Invitae. "The PCM platform complements current monitoring
methods, and has the ability to determine a cancer therapy's
effectiveness earlier than those methods for many patients,
allowing clinicians the opportunity to refine treatment
options."
Over the past several years, research from Invitae and the
greater scientific community, including the TRACERx study led
by Professor Charles Swanton at the
Francis Crick Institute and University College London (UCL), and
funded by Cancer Research UK, has shown that MRD monitoring can
reliably identify lung cancer patients at high risk of relapse,
detect post-surgical recurrence often earlier than standard
imaging, assess therapy response, and potentially act as a
surrogate for clinical trial endpoints. With these capabilities,
MRD monitoring promises to shorten clinical trials and accelerate
the development of potentially life-saving new drugs. Invitae PCM
is a pan-cancer, tumor-informed liquid biopsy assay, co-developed
with the TRACERx consortium, that uses a next generation sequencing
(NGS) to analyze ctDNA in a patient's plasma.
"MRD is an important biomarker in the adjuvant and surveillance
period," said Professor Charles
Swanton, MBPhD, FRCP, FMedSci, FRS, FAACR, at the Francis
Crick Institute and UCL Cancer Institute and Chief Clinician of
Cancer Research UK. "As we've seen in the TRACERx study, PCM
provides prognostic information, can aid in cases of radiographic
ambiguity, and demonstrates high clinical sensitivity and
specificity."
Liquid biopsy tests have been available for therapy selection,
but to identify MRD at an earlier stage than conventional methods
before patients clinically relapse, the technology must be
sensitive enough to detect ctDNA at very low levels. Additionally,
an MRD test with high specificity is also needed to reduce the
likelihood of false positive results. The PCM test utilizes
advanced technologies to arrive at high levels of sensitivity and
specificity, detecting tumor DNA at very low levels of
concentrations in peripheral blood. Validation studies
demonstrate greater than 99.9% sensitivity in detecting ctDNA
at a 0.008% variant allele frequency.
"We are excited about PCM availability globally, as this is an
evolving area where we have invested over the last year and we
believe has the potential to give patients the information needed
to understand their recurrence risk to fight and beat the disease,"
said Sean George, Ph.D., co-founder
and CEO of Invitae.
Each assay is custom designed to detect a patient's unique tumor
signature, allowing for personalized results to guide treatment
decisions. Invitae PCM requires both blood and tumor tissue samples
from the patient to conduct tumor-normal whole exome sequencing
(WES). Based on the results, Invitae's proprietary algorithm
selects 18-50 tumor-specific variants to include on the patient's
custom-designed ctDNA panel. This range of variants allows for a
balance of highly sensitive and specific MRD detection in cancers
that have lower or higher mutational burdens.
If an MRD-positive result is obtained at any point in a cancer
patient's journey, the clinician and patient can discuss the
implications of the result and the most appropriate treatment or
clinical trial options. "This molecular knowledge impacts cancer
patients throughout their cancer journey, making this a mainstay in
precision oncology," said George.
Invitae is actively expanding the research portfolio globally to
continue to gather data on PCM clinical utility as well as
MRD-guided studies. Invitae anticipates multiple publications this
year across its PCM studies in lung, breast, head and neck, and GI
tumors as well as several prospective studies kicking off in the
first half of the year. These prospective studies include a
pan-tumor study (MARIA) and several studies in breast and GI
cancers, including ARTEMIS, a study examining Invitae's PCM
offering specifically for patients with pancreatic cancer. The
study will be conducted in partnership with a high profile
institution near Tokyo, the
National Cancer Center Hospital East, Kashiwa, Chiba, Japan. Sample collection will begin in
Q2 2022.
For more information about Invitae PCM, visit Invitae.
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.
About TRACERx Study
TRACERx (TRAcking Cancer Evolution
through therapy (Rx)) lung study is the single biggest investment
in lung cancer research by Cancer Research UK. Taking place over
nine years, we believe the translational research programme is the
first study to look at the evolution of cancer in real time and in
immense detail. Researchers follow patients with lung cancer all
the way from diagnosis through to either disease relapse or cure
after surgery, tracking and analysing how their cancer develops.
TRACERx is led by the University College London via the Cancer
Research UK Lung Cancer Centre of Excellence and also supported by
the National Institute for Health Research, University College
London Hospitals Biomedical Research Centre, Francis Crick
Institute and the Rosetrees Trust.
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 PCM platform; the company's beliefs regarding the
benefits of MRD monitoring; and the company's plans to continue to
gather data on PCM clinical utility and conduct MRD-guided studies.
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 Annual Report on Form 10-K for the
year ended December 31, 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/invitae-launches-full-access-to-its-liquid-based-personalized-cancer-monitoring-platform-to-help-detect-disease-earlier-301504532.html
SOURCE Invitae Corporation