- Significant changes made to current NCCN
testing recommendations increase access to testing for historically
underserved populations -
SAN
FRANCISCO, Aug. 8, 2022 /PRNewswire/ -- As a
result of recent research revealing that a significant number of
colorectal cancer patients with actionable variants are missed
under previous genetic testing guidelines, the National
Comprehensive Cancer Network (NCCN) announced new
guidelines calling for testing to be available to all patients
diagnosed with colorectal cancer. Specifically, NCCN recommended
that germline multigene panel testing should be offered to all
individuals with CRC age <50 and be considered for all
others, particularly for, but not restricted to, those with
evidence of mismatch repair in their tumor or suggestive family
history. These new recommendations expand the current testing
criteria, which limited testing to certain age groups and types of
cancer.
The new NCCN guidelines follow recent landmark studies published
in JAMA Oncology and Clinical Gastroenterology and
Hepatology by Invitae and Mayo Clinic supporting
universal genetic testing for all cancer patients, regardless of
cancer type, age, stage or family history. The data showed that
nearly 1 in 6 colorectal cancer patients had inherited gene
mutations that increased their risk of cancer. Additionally, more
than 10% of patients in the study had changes to their cancer
treatments based on genetic testing findings – many of whom would
have been missed by previous limited testing guidelines. The study
also found that patients diagnosed with colorectal cancer at a
younger age were more likely to have heritable genetic changes
linked to an increased risk of cancer.
The new NCCN guidelines have the potential to impact millions,
as colorectal cancer is the third most diagnosed cancer and an
estimated 5 million people worldwide currently live with
colorectal cancer according to the American Cancer Society. The
lifetime risk of developing colorectal cancer according to ACS is
about 1 in 23 for men and 1 in 25 for women, and there's recently
been an increase in incidence among people younger than 50 years
old. Understanding risk and implementing screening strategies is
essential to early detection and better outcomes for patients.
"As the medical community's understanding of genetic links to
cancer evolves, genetic testing guidelines must evolve with it,"
said Robert Nussbaum, M.D., chief
medical officer of Invitae, who co-authored a letter in
January 2022 to the NCCN formally
requesting universal germline testing for patients with CRC be
added to their guidelines. "In addition to excluding older people
from receiving access to medically actionable information about
their disease, previous guidelines were based on studies with an
overrepresentation of individuals of European origin, potentially
biasing and exacerbating existing disparities to those of
non-European background."
"The number of genes with targeted therapeutic or clinical
management implications for colorectal cancer has significantly
increased in recent years," Dr. Nussbaum continued. "At the same
time, genetic testing has become more affordable. These new
guidelines will help identify more patients and their family
members who might benefit from genetic assessment."
"The INTERCEPT study supports the use of universal germline
genetic testing for patients with colorectal cancer, and has shown
the clinical impact of this strategy in targeted therapy
implementation, personalized clinical management and cascade family
testing for prevention. The NCCN update will improve access for
patients with colorectal cancer to the gene-directed precision care
they need," Jewel Samadder, M.D.,
enterprise co-leader precision/individualized cancer medicine, Mayo
Clinic Comprehensive Cancer Center.
In addition to recommending testing be either offered or
considered for all diagnosed colorectal cancer patients, the NCCN
guidelines recommend subsequent cascade testing of family members
of colorectal cancer patients who have pathogenic variants
identified in cancer risk genes. "This is one of the biggest
challenges related to germline multigene panel testing for all
colorectal cancer patients," explained Ed
Esplin, M.D., Ph.D., FACMG, FACP, clinical geneticist at
Invitae and a co-author of the INTERCEPT study. "Alerting other
family members to be tested to determine increased risk and
implementing more intensive surveillance could lead to earlier
diagnosis, significantly higher chance of curative treatment and
ultimately, prevention of colorectal cancer entirely for those at
increased risk."
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 potential impact of the new NCCN
guidelines and the potential benefits of increased access to
genetic 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 March 31, 2022. These forward-looking statements
speak only as of the date hereof, and Invitae
Corporation disclaims any obligation to update these
forward-looking statements.
Contact:
Amy Hadsock
pr@invitae.com
(628) 213-3283
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SOURCE Invitae Corporation