– Helps to detect circulating tumor DNA
(ctDNA) as a biomarker in clinical research and clinical trials for
solid tumor malignancies –
– May provide real-time data on therapy
response, support patient prognostic stratification and enable
early detection of residual disease –
SAN
FRANCISCO, Nov. 6, 2023 /PRNewswire/ -- Invitae
(NYSE: NVTA), a leading medical genetics company, today
announced enhanced chemistry of its Invitae Personalized Cancer
Monitoring™ platform that helps detect
circulating tumor DNA (ctDNA) as a biomarker for solid tumor
malignancies. ctDNA can provide real-time insights on patient
response or disease progression, support patient prognostic
stratification and enable early detection of residual
disease.
The enhanced assay, which received Clinical Laboratory
Improvement Amendments (CLIA) approval, features a flexible
patient-specific panel design of between 18 and 50 variants,
demonstrating a sensitivity of >99% for detecting ctDNA at
variant allele frequencies as low as 0.005%. In addition, the
company has also received CLIA approval on the whole exome
sequencing component of PCM as a stand-alone comprehensive genomic
profiling (CGP) assay to permit reporting of tumor
profiles.
In our commitment to continual innovation, the enhanced
assay achieves a number of benefits. Compared to our prior version,
the enhanced assay permits a new lower mass input limit that
results in the same sensitivity as the prior version with less
cell-free DNA (cfDNA), enabling Invitae to test samples that might
have been previously rejected. The enhanced assay also involves
fewer steps that will increase capacity and reduce the burden of
materials and labor costs. Lastly, the enhanced chemistry is
automation friendly enabling scale and supporting future
growth.
"This focused launch and enhanced chemistry will enable
biopharma partners to detect recurring disease early," said
Bob Daber, Ph.D., chief scientific
officer of Invitae. "This will potentially help set MRD as a
standard practice in clinical studies and increase the velocity of
drug development. Our vision is that insights gained from Invitae
Personalized Cancer Monitoring will lead to research breakthroughs
that positively influence patient journeys."
"With Invitae Personalized Cancer Monitoring, biopharma
researchers will have information they need to inform clinical
trial design and study patient outcomes, ultimately to help bring
new cancer therapies that benefit patients to market," added Dr.
Daber.
To learn about Invitae Personalized Cancer Monitoring, please
contact partners@invitae.com.
About Invitae Personalized Cancer Monitoring™
Invitae Personalized Cancer Monitoring is a multi-cancer,
tumor-informed, long-term monitoring assay that incorporates
next-generation sequencing libraries featuring both unique
molecular identifiers (UMIs) and updated anchored multiplex PCR
(AMP) chemistry. Invitae Personalized Cancer Monitoring provides
personalized ctDNA detection and quantitation from the peripheral
blood in patients with solid tumors.
Biopharma researchers can utilize the validated Invitae
Personalized Cancer Monitoring platform to detect residual cancer
at the molecular level. By assessing the presence and levels of
ctDNA over time, Invitae Personalized Cancer Monitoring provides a
highly sensitive approach to detect residual cancer in patients who
have undergone surgery and other definitive therapies, thus
informing further diagnostic and therapeutic decisions, leading to
potentially improved outcomes. The assay can also provide molecular
information on the extent of response to therapeutic interventions,
in various clinical settings, which may assist in optimizing
clinical studies and accelerating drug development.
Currently established clinical practice involves utilizing
imaging as a means to detect residual disease and tumor changes,
which might result in delayed detection of disease recurrence and
inaccurate assessment of therapeutic response. Biopharma
researchers need a faster and more reliable way to understand
therapeutic responses to novel drug regimens. The Invitae
Personalized Cancer Monitoring assay may provide such information.
For example, in a study of non-small cell lung cancer, a ctDNA
assay based on the Invitae Personalized Cancer Monitoring platform
detected relapse prior to standard clinical diagnosis via imaging
by almost four months.
About Invitae
Invitae (NYSE: NVTA)
is a leading medical genetics company trusted by millions of
patients and their providers to deliver timely genetic information
using digital technology. We aim to provide accurate and actionable
answers to strengthen medical decision-making for individuals and
their families. Invitae's genetics experts apply a
rigorous approach to data and research, serving as the foundation
of their mission to bring comprehensive genetic information into
mainstream medicine to improve healthcare for billions of
people.
To learn more, visit invitae.com and follow for updates on
Twitter, Instagram, Facebook and LinkedIn @Invitae.
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 potential benefits of the enhanced
chemistry of the Invitae Personalized Cancer
MonitoringTM test; that the company's focused
launch and enhanced chemistry will enable biopharma partners to
detect recurring disease early, potentially help set MRD
as a standard practice in clinical studies and increase the
velocity of drug development; and the company's vision that
insights gained from its test will lead to research breakthroughs
that positively influence patient journeys. 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 ability to grow its business in a cost-efficient manner;
the company's history of losses; the company's ability to maintain
important customer relationships; the company's ability to compete;
the company's need to scale its infrastructure in advance of demand
for its tests and to increase demand for its tests; the risk that
the company may not obtain or maintain sufficient levels of
reimbursement for its tests; the applicability of clinical results
to actual outcomes; risks associated with litigation; 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 June 30, 2023.
These forward-looking statements speak only as of the date hereof,
and Invitae Corporation disclaims any obligation to
update these forward-looking statements.
Invitae PR contact:
Renee
Kelley
pr@invitae.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/invitae-launches-enhanced-chemistry-of-mrd-test-to-better-serve-biopharmaceutical-clinical-and-research-partnerships-301979094.html
SOURCE Invitae Corporation