SAN FRANCISCO, Jan. 14, 2021 /PRNewswire/ -- Invitae
Corporation (NYSE: NVTA), a leading medical genetics company, today
announced the launch of a new project with Bristol Myers Squibb,
Janssen Research & Development, LLC (Janssen), Novartis and
Genentech, a member of the Roche Group, to develop a standardized
panel for MRD detection in patients with AML to support clinical
trial testing across multiple drug development programs. The
companies are working together to standardize how MRD data is
generated and assessed in clinical trials helping to better
establish the clinical utility of MRD as a biomarker in AML.
"Given the existing evidence that shows assessing the presence
of MRD can provide valuable information on how well a treatment may
be working, we hope to further establish MRD detection as an
objective tool for clinicians to create the best treatment plan for
individual patients," said Jason
Myers, Ph.D., president of oncology at Invitae. "Together
with leading, global biopharmaceutical companies, Bristol Myers
Squibb, Janssen, Novartis and Genentech, we intend to develop a
panel that can accurately measure and standardize MRD data
collection in clinical trials with the goal of accelerating trial
timeframes to bring novel therapies to patients in need
sooner."
MRD is the detection of residual disease after treatment based
on the presence of molecular biomarkers when the remaining cancer
cells are not detectable by conventional methods. The detection of
MRD typically relies on highly sensitive and specific technologies
such as next-generation sequencing, which has become more commonly
used in recent years. Specifically, in AML and other blood cancers,
studies have shown the presence of MRD after treatment may predict
survival outcomes for patients.
While a growing body of evidence continues to demonstrate a
correlation between MRD and the risk of disease relapse or
recurrence among other prognostic factors, lack of standardization
of MRD technologies and assessment methods have slowed the
acceptance of MRD as a clinical trial endpoint in AML. Another goal
of the project is to further evaluate MRD as a predictive biomarker
and clinical trial endpoint to assess the effectiveness of novel
therapies.
"We're proud to be working with these leading companies to
further refine the standards for MRD detection and help establish
its utility as an accurate and rapid indicator of treatment
effect," said Sean George, Ph.D.,
co-founder and chief executive officer of Invitae. "Standardized
MRD results can help give providers confidence they are creating a
personalized plan for their patients with the goal of improving
quality of life and overall survival."
The multi-gene, next-generation sequencing panel is expected to
be used in AML clinical trials to measure baseline molecular status
as well as track MRD status. The panel will be built on Invitae's
Anchored Multiplex PCR (AMP™) chemistry, allowing the tests to be
completed in laboratories at local clinical trial testing sites
across the globe, reducing turnaround time for results.
Approximately 50%-60% of de novo AML and 80%-90% of secondary
AML patients have genetic alterations. The comprehensive
next-generation sequencing panel is being designed to detect more
than 90% of the genetic alterations associated with AML, including
key molecular targets CEBPA, FLT3, IDH1 and IDH2.
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 ability of the company to develop a standardized
panel for MRD detection; the expected benefits to the parties, and
to patients and clinicians, of any MRD panel developed by the
company; the attributes of any MRD panel developed by the company;
and the expected uses of any MRD panel developed by the company.
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 ability of the company to successfully develop the
panel; the applicability of clinical trials to actual outcomes; 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; the impact of litigation on the company's
business; 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, 2020.
These forward-looking statements speak only as of the date hereof,
and Invitae Corporation disclaims any obligation to update these
forward-looking statements.
Contact:
Laura D'Angelo
pr@invitae.com
(628) 213-3283
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