– Invitae retrospective analysis reinforces the
clinical actionability of following the ASBrS guidelines
–
– Testing results informed clinical management
and suggest that genetics-informed care may improve patient
outcomes and optimize resource utilization –
SAN
FRANCISCO, Oct. 12 , 2023 /PRNewswire/ --
Invitae (NYSE: NVTA), a leading medical genetics company,
today announced results of its collaborative study on universal
hereditary cancer genetic testing in all patients with breast
cancer in a rural population in the Annals of Surgical
Oncology. Conducted in collaboration with The Outer Banks
Hospital (TOBH) in North Carolina
from 2019 to 2022, the study analyzed the implementation of
universal hereditary cancer genetic testing in all patients with
breast cancer, as recommended by the American Society of Breast
Surgeons (ASBrS) guidelines in 2019. The results reaffirm
the previous findings of Whitworth et al. that universal
hereditary cancer genetic testing improves patient outcomes and
shows testing based de-escalation of therapy which may curtail
treatment costs.
In the study, all patients diagnosed with breast cancer were
offered hereditary cancer genetic testing and 91.4% underwent
testing and received results that could aid in their healthcare
journey. Approximately half of the patients (52.4%) met National
Comprehensive Cancer Network (NCCN) criteria while 45.8% did not
meet the NCCN criteria. Implementation of universal hereditary
cancer genetic testing in this rural healthcare system was
facilitated by genetics-trained clinicians who provided pretest
education and results disclosure, with treatment recommendations
discussed at multidisciplinary tumor boards. Of the patients who
underwent testing, 13% had a pathogenic (disease-causing) germline
variant (PGV) in one of 15 genes and the frequency of PGVs did
not differ between out of criteria and in criteria patients,
although in criteria patients had a larger proportion of high risk
variants than the out of criteria patients, consistent with
previous findings of Beitsch et al. Currently, NCCN criteria
restrict hereditary cancer genetic testing to a subset of patients
with breast cancer while these data provide further evidence
confirming the ASBrS recommendation of universal testing for
all patients with breast cancer as the standard of care.
"This study demonstrates the feasibility of implementing
universal hereditary cancer genetic testing for patients with
breast cancer in rural community practices," said Robert Nussbaum, M.D., chief medical officer at
Invitae. "The results reiterate in a real-world setting that
genetic testing changes management and treatment plans for these
patients, improving patient care."
Genetic testing-informed changes to clinical management,
including changes in surgery, radiation, surveillance and
clinical-follow up, occurred in 70% of patients. The majority of
patients (97%) reported that testing results were useful in shared
surgical decision-making and that knowledge of the results prior to
their primary therapy reinforced their choice for surgery.
"Our study provides a blueprint for implementing universal
hereditary cancer genetic testing in rural populations who
typically see disproportionate care due to access to services and
treatment," said Charles Shelton,
M.D., lead author of the study and radiation oncologist at TOBH.
"We demonstrate that germline-directed clinical management did not
lead to under- or overuse of radiation therapy or bilateral
mastectomy, thus demonstrating that universal testing enables
optimization of clinical care and reduces unnecessary healthcare
resource utilization."
To learn more about germline genetic testing, visit our
website or contact us.
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 company's beliefs regarding its study results; the
company's belief that the results demonstrate the clinical benefits
of universal hereditary cancer genetic testing in patients with
breast cancer; the company's belief that the study reinforces the
clinical actionability of following the ASBrS guidelines; the
company's belief that the study demonstrates the feasibility of
implementing universal hereditary cancer genetic testing for
patients with breast cancer in rural community practices; and that
genetics-informed care may improve patient outcomes and optimize
resource utilization. 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
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SOURCE Invitae Corporation
