SAN FRANCISCO, June 3, 2021 /PRNewswire/ -- Invitae
Corporation (NYSE: NVTA), a leading medical genetics company, today
announced it has begun offering early access to its new
Personalized Cancer Monitoring (PCM™) platform as a
laboratory-developed test performed at an Invitae central
laboratory. The service employs a novel combination of a tumor
profile, blood tests and personalized assays based on a patient's
tumor with the goal of detecting circulating tumor DNA (ctDNA)
before it is detectable by imaging or other conventional methods,
offering earlier detection of cancer recurrence.
"Far too many patients who undergo treatment for cancer still
relapse, and the cause is often the development of new cancer cell
populations. One promising strategy for identifying recurrence
early is to detect these cancer cells persisting in a patient after
treatment, known as minimal residual disease (MRD), that cannot be
detected with standard monitoring such as imaging," said
Robert Nussbaum, M.D., chief medical
officer of Invitae. "PCM has the potential to determine a therapy's
effectiveness much sooner than current monitoring methods, allowing
clinicians to more efficiently refine and optimize treatment plans.
In addition, patients whose cancer has been cured by tumor
resection may be spared from unnecessary and potentially harmful
adjuvant therapy, while those at risk of relapse can be diagnosed
earlier and treated with the necessary therapies."
During the early access program, academic and pharmaceutical
researchers will be able to utilize the pan-cancer, CAP-accredited
and CLIA-certified PCM platform with testing and reporting
completed by Invitae's recently acquired laboratory in Iselin, New Jersey. Full commercial
availability of PCM as a laboratory-developed test is expected
later this year.
PCM is a pan-cancer, tumor-informed, liquid biopsy assay
developed by Invitae to detect MRD and monitor for cancer
recurrence. Clinical researchers may have the ability to have
residual disease and/or cancer recurrence detected earlier than the
current standard of care for most patients. By detecting residual
disease/recurrence earlier, patients can be considered for therapy
sooner, which may result in improved outcomes.
PCM includes three basic steps: 1. A patient's surgically
removed tumor or tumor biopsy and blood undergoes whole exome
sequencing to create a patient specific tumor fingerprint. 2.
Approximately 50 tumor-specific variants are selected for inclusion
on a personalized ctDNA panel. 3. Patient-specific assays are
created that can be used over time with minimally invasive blood
draws to monitor for disease recurrence.
The platform is powered by Invitae's Anchored Multiplex PCR
(AMP™) chemistry to perform error-corrected, next-generation
sequencing. It is designed to identify traces of a patient's
original tumor DNA circulating in a patient's blood, or ctDNA.
Because ctDNA is a biomarker for MRD, AMP chemistry enables high
sensitivity detection of MRD status. Detecting minute amounts of
ctDNA while confidently determining MRD status may allow for
earlier detection of relapse after treatment.
The high sensitivity and specificity of the PCM assay has been
validated both in the laboratory and among NSCLC patients in the
TRACERx study. Clinical validation studies will continue, as will
the use of PCM to address research questions in support of
meaningful clinical applications. Once more data become available
in these important areas, PCM and other liquid biopsy approaches
for monitoring MRD have the potential to become a mainstay in
PCM could be applied in a variety of ways to help improve
patient care and prolong survival outcomes. Its possible
applications in the clinical setting include monitoring for
recurrence, monitoring a patient's response to therapy to guide
treatment decisions, and improving clinical trial designs to help
get new therapies to market sooner.
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 potential benefits of PCM; the features of the
early access program for PCM; the company's expectations regarding
the timing of full commercial availability of PCM as a
laboratory-developed test; the company's expectations regarding the
continuation of clinical validation studies and the use of PCM in
research; the potential for PCM to become a mainstay in
personalized oncology; and possible applications of PCM.
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 March 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.
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SOURCE Invitae Corporation