– Research published in European Urology Oncology
shows restrictive genetic testing criteria miss a significant
number of prostate cancer patients with potentially actionable
inherited variants –
– Offering germline testing to all prostate
cancer patients could improve access to critical genetic
information, particularly for historically underrepresented groups
–
SAN
FRANCISCO, Aug. 15, 2023 /PRNewswire/
-- Invitae (NYSE: NVTA), a leading medical genetics
company, today announced findings from its PROCLAIM trial,
published in European Urology Oncology, showing that almost half of
prostate cancer patients with clinically actionable
pathogenic/likely pathogenic germline variants (PGVs) could be
missing out on genetics-informed care due to restrictive criteria
for genetic testing.
In this prospective, observational study, nearly 1,000 men with
prostate cancer unselected for family history of cancer, age at
diagnosis or stage of disease, underwent germline genetic testing
of 84 cancer predisposition genes under the care of urologists
across the U.S., primarily in community clinics. In this
study, 51% of patients with prostate cancer met National
Comprehensive Cancer Network (NCCN) guidelines and 49% did not. The
diagnostic yield of germline genetic testing between these two
patient groups was compared.
"Real world evidence suggests that less than 15% of prostate
cancer patients who could benefit from genetics-informed care
undergo genetic testing, in part due to complicated and prohibitive
testing guidelines," said Neal
Shore, M.D., F.A.C.S., from the Carolina Urologic Research
Center in Myrtle Beach, South
Carolina, and the principal investigator of the study. "We
found no statistically significant difference in the diagnostic
yield of PGVs between those who met NCCN guidelines and those who
did not, suggesting there are a significant number of patients with
PGVs, many of which are targets for precision therapies, who are
being missed when adhering to current NCCN guidelines for genetic
testing."
Among nearly 1,000 patients (median age at diagnosis was 65
years), 65% had low-or intermediate-risk disease. A total of 77
PGVs in 17 genes were identified in 7.7% of the cohort. No
significant difference was found in the prevalence of PGVs (8.8%)
among the 51% of patients who met 2019 NCCN prostate criteria
versus the remaining 49% who did not (6.6%), indicating that these
criteria would miss 41.9% of patients with PGVs.
The data show nearly 80% of men with PGVs had potentially
clinically actionable variants, including those in genes with
eligibility for approved precision therapies or clinical treatment
trials. When stratified by self-reported ethnicity, non-white
(predominantly Black) men who were out-of-criteria had a higher
number of PGVs than those who were in-criteria, suggesting current
criteria disproportionately disadvantage historically
underrepresented populations from obtaining critical genetic
information. This disparity is particularly disturbing given Black
men with prostate cancer are known to present with more aggressive
disease.
"According to the American Cancer Society, prostate cancer is
the second most common cancer in American men. Considering how
common this diagnosis is, it's critical that individuals are
offered the proper screenings and access to necessary preventive
measures to assess their risk and detect cancer as early as
possible," said W. Michael Korn,
M.D., chief medical officer for oncology at Invitae. "Through this
study, we are seeing how genetic testing can play a vital role in
understanding a prostate cancer diagnosis, as it can inform
different types of treatment that might work best for a patient's
individual needs."
The findings support broadening the current guidelines and
offering germline genetic testing to all patients with prostate
cancer. This could change the standard of medical care for these
patients, expanding access to precision therapies, clinical trial
treatments and enhanced screening.
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 clinical trial
results; the company's beliefs that the results demonstrate the
utility of expanding germline genetic testing guidelines; and the
company's beliefs regarding the benefits of offering germline
genetic testing to all prostate cancer patients, including that it
could change the standard of care for these patients.
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:
Amanda McQuery
pr@invitae.com
(628) 213-3283
View original content to download
multimedia:https://www.prnewswire.com/news-releases/clinical-trial-results-support-genetic-testing-of-all-patients-with-prostate-cancer-301900284.html
SOURCE Invitae Corporation