– Clinicians agree that evidence supports
testing benefits for all –
SAN
FRANCISCO, Sept. 15, 2022 /PRNewswire/ -- Invitae
(NYSE: NVTA), a leading medical genetics company, joined other
clinical experts in releasing a new commentary in Journal of
Clinical Oncology Precision Oncology, underscoring the
importance of universal germline testing for all patients with
cancer (solid tumors). The paper reports a meta-analysis of
multiple clinical publications supporting universal testing,
independent of age, stage, family history or type of cancer. It
reports that for cancer types such as pancreatic and ovarian where
universal genetic testing is already recommended, 13% and 20% of
patients (respectively) have identifiable actionable heritable gene
mutations,2. In comparison, the actionable inherited
gene mutation rate for patients with other cancer types is similar:
breast 11%, endometrial 13%, prostate 14%, kidney 13%, bladder 14%,
testicular 13%, colorectal 13%, liver 14%, and stomach 14%.
Furthermore, it reports that between 5-13% of patients with
cancer with heritable gene mutations are missed by current
restrictive testing guidelines and are unable to benefit from
associated precision treatment and clinical trial benefits. First,
allowing all patients to receive germline testing, without
restrictive guidelines, affords patients access to precision
therapies, clinical trials and other risk reducing interventions
that can improve outcomes, and even extend overall patient
survival1. Second, genetic testing informs surveillance
and risk reduction for future cancers in patients already affected
by cancer. Third, cascade testing helps alert their family members
of an increased risk for cancer, so they too can then take
advantage of monitoring and risk reducing interventions. Consistent
with the Cancer Moonshot 2.0 and the President's Cancer Panel
report 2022, the expert consensus concludes that current evidence
supports the implementation of universal germline genetic testing
for all patients with cancer (solid tumors).
"This consensus from nationally recognized, cancer genetics
clinical experts reinforces the current guidelines that universal
genetic testing be offered in all patients with ovarian and
pancreatic cancer and either be offered or considered in all
patients with colorectal," said Ed
Esplin, MD, PhD, FACMG, FACP, clinical geneticist at
Invitae. "More importantly, this is a call to all guidelines
committees, insurer medical policy makers and the President's
Cancer Moonshot Cabinet to make universal genetic testing
available to potentially reduce mortality and improve the lives of
all patients with cancer."
The collaborative commentary included experts from the Carolina
Urologic Research Center, City of Hope, Dana-Farber Cancer
Institute, Mayo Clinic and Invitae.
"The PROCLAIM study demonstrates the clinical utility
of universal germline genetic testing in patients with prostate
cancer. Current NCCN guidelines preclude some prostate cancer
patients from receiving germline testing, thus depriving these
patients of the potential to receive precision-based therapies and
specific clinical trial eligibility, while perpetuating
healthcare disparities among historically underrepresented
populations. The PROCLAIM data supports universal genetic testing
for prostate cancer patients. We should expeditiously eliminate
barriers to gene-based precision therapies to optimize patient
outcomes and accelerate equitable access to care," said
Neal Shore, MD, urologist and
medical director, Carolina Urologic Research Center.
Cancer is a leading cause of death worldwide, accounting for
nearly 10 million deaths in 2020.
Worldwide, there were an estimated 18.1 million new cases of
cancer in 2018, with one in four men and one in five women
developing the disease. In addition, there were 43.8 million
persons living with cancer in 2018 who were diagnosed within the
last five years.
"The INTERCEPT study has shown the prevalence and clinical
utility of germline genetic testing is virtually the same across 14
cancer types, even those cancers not traditionally considered
hereditary. This data supports universal genetic testing not only
for colorectal cancer, but patients with all cancer types, to
potentially improve their treatment and future cancer prevention
for them and their family members," said Jewel Samadder, MD, enterprise co-leader
precision/individualized cancer medicine, Mayo Clinic Comprehensive
Cancer Center.
Restrictive guidelines can lead to disparities in cancer care.
Offering germline genetic testing to all patients with cancer at
diagnosis may help reduce inequities in cancer care by expanding
access for all patients to precision therapy or clinical treatment
trials.
"The prevalence of pathogenic variants in cancer susceptibility
genes for which there are management guidelines is similar among
patients with all types of solid tumors, therefore, it does not
makes sense that current guidelines only recommend germline genetic
testing for all patients with ovarian, pancreatic, and recently,
colorectal cancers. This information has the potential to affect
the treatment of these individuals' current cancers. In addition,
it has the potential to allow for the prevention or early detection
of future cancers in both these patients and their family members,"
said Heather Hampel, MS, CGC,
professor, Department of Medical Oncology & Therapeutics
Research, City of Hope.
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 benefits of universal genetic testing for
all patients with cancer; and that restrictive guidelines can lead
to disparities in cancer care. 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 June 30, 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:
Renee Kelley
pr@invitae.com
(628) 213-3283
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