– First-of-its-kind authorization provides
potential marketing differentiation and opportunities for largest
testing category –
– Testament to Invitae's product and lab quality
–
– Sets the bar for expected performance and
the associated data required for future regulatory approval of
similar products –
SAN
FRANCISCO, Oct. 3, 2023 /PRNewswire/
-- Invitae (NYSE: NVTA), a leading medical genetics
company, today announced it gained FDA market authorization for its
Common Hereditary Cancers Panel. This represents the first broad
panel that is used to identify germline variants associated with
hereditary cancer to gain market authorization from the FDA. The
company believes that this is a strong vote of confidence in its
Common Hereditary Cancers Panel, which has the potential to benefit
patients, providers and payers.
Through this application, Invitae was able to establish a new
category of device based on its testing technology and methodology
which provides potential marketing differentiation and
opportunities for its largest testing category. In 2021, the
company submitted a de novo application using the Common Hereditary
Cancers Panel as an example of a methods-based approach to
validation. The FDA worked closely with Invitae to review the test
and its supporting data, which led to this authorization being
granted on September 29, 2023.
"This is incredibly exciting news for Invitae. We were able to
demonstrate that the way the technology works can be well
characterized based on variant type and genomic context and is
consistent across genes," said Robert
Nussbaum, M.D., chief medical officer at Invitae. "The fact
that we were able to do this is a testament to Invitae's quality
and rigorous validation process that met the agency's
standards."
About the Common Hereditary Cancers Panel
The Invitae Common Hereditary Cancers Panel is an in
vitro diagnostic test focused on 47 genes already known to
contain tens of thousands of genetic variants that increase risk of
developing certain cancers. Hereditary cancer testing represents
the largest business line of Invitae's testing portfolio, and
multiple peer-reviewed
studies1 published in recent years have
demonstrated its clinical utility. That utility includes
determining the potential risk for cancer, informing management and
treatment of those with the disease and helping to prevent disease
in those at increased risk. To learn more, visit our website.
Intended Use of the Market Authorization
The Invitae Common Hereditary Cancers Panel is a qualitative
high throughput sequencing-based in vitro diagnostic test
system intended for analysis of germline human genomic DNA
extracted from whole blood for detection of substitutions, small
insertion and deletion alterations and copy number variants (CNV)
in a panel of targeted genes. This test system is intended to
provide information for use by qualified health care professionals
in accordance with professional guidelines, for hereditary cancer
predisposition assessment and to aid in identifying hereditary
genetic variants potentially associated with a diagnosed cancer.
The test is not intended for cancer screening or prenatal
testing. Results are intended to be interpreted within the
context of additional laboratory results, family history and
clinical findings. The test is a single-site assay performed at
Invitae Corporation.
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 potential impact of the FDA market
authorization of the company's Common Hereditary Cancers Panel,
including potential market differentiation and opportunities; the
company's belief that the FDA's authorization is a testament to its
product and lab quality; the company's belief that the FDA's
authorization is a strong vote of confidence in its panel and has
the potential to benefit patients, providers and payers; and the
effect of the FDA authorization on future regulatory approval of
similar products. 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
commercialize the Common Hereditary Cancer Panel that received FDA
market authorization and the timing thereof; the company's need to
update the Common Hereditary Cancer Panel and its submission to the
FDA; 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 company's ability to use
rapidly changing genetic data to interpret test results accurately
and consistently; risks associated with litigation; 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 Contacts:
Investor Relations
Hoki
Luk
ir@invitae.com
Public Relations
Amanda McQuery
pr@invitae.com
1 Neal
Shore et al.,Efficacy of National Comprehensive Cancer
Network Guidelines in Identifying Pathogenic Germline Variants
Among Unselected Patients with Prostate Cancer: The PROCLAIM Trial,
European Urology Oncology, August
2023; Pat. W. Whitworth et al., Clinical Utility of
Universal Germline Genetic Testing for Patients With Breast Cancer,
JAMA Network Open, September 2022;
Edward Esplin et al., Universal
Germline Genetic Testing for Hereditary Cancer Syndromes in
Patients With Solid Tumor Cancer, JCO Precision Oncology,
September 2022; Sarah E. Coughlin et al., Multigene Panel
Testing Yields High Rates of Clinically Actionable Variants Among
Patients With Colorectal Cancer, JCO Precision Oncology,
November 2022; Whitney Espinel et al., Clinical Impact of
Pathogenic Variants in DNA Damage Repair Genes beyond BRCA1
and BRCA2 in Breast and Ovarian Cancer Patients, Cancers,
May 2022; Pedro L. Uson Jr. et al., Germline Cancer
Susceptibility Gene Testing in Unselected Patients With Colorectal
Adenocarcinoma: A Multicenter Prospective Study, Multicenter Study,
Clin Gastroenterol Hepatol, March
2022; N. Jewel Samadder et
al., Comparison of Universal Genetic Testing vs Guideline-Directed
Targeted Testing for Patients With Hereditary Cancer Syndrome, JAMA
Oncology, February 2021; Piper Nicolosi et al., Prevalence of Germline
Variants in Prostate Cancer and Implications for Current Genetic
Testing Guidelines, JAMA Oncology, April
2019; Peter D. Beitsch et
al., Underdiagnosis of Hereditary Breast Cancer: Are Genetic
Testing Guidelines a Tool or an Obstacle?, J Clinical Oncology,
December 2018.
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SOURCE Invitae Corporation