Veracyte, Inc. (Nasdaq: VCYT) announced today that new data
relating to the Prosigna® Breast Cancer Gene Signature Assay will
be presented at the European Society of Medical Oncology (ESMO)
Breast Cancer Virtual Congress 2021 taking place May 5-8.
“New data accepted for presentation at this year’s ESMO Breast
Cancer Congress provide further evidence for the importance of
genomic testing in breast cancer, particularly to help physicians
and patients make better informed treatment decisions based on the
unique biology of individual patients’ tumors,” said Bonnie
Anderson, Veracyte’s chairman and chief executive officer. “We
believe such data strengthen the backdrop for our Prosigna Breast
Cancer Gene Signature Assay, and greatly appreciate the breast
cancer experts who led and participated in these studies.”
Following are details of the Prosigna-related posters accepted
for presentation at the ESMO Breast Cancer Virtual Congress. These
abstracts are available to meeting registrants on demand:
Title:
Influence of PAM50 on therapeutic
decisions in patients with early-stage Luminal Breast Cancer in a
single centre
Poster:
62P
First Author:
Alejandro Olivares-Hernandez,
M.D., M.Sc., IBSAL - Instituto de Investigación Biomédica de
Salamanca, Salamanca, Spain
Title:
Consensus on the utility of
breast cancer multigene signatures in routine clinical practice
among European Breast Cancer clinicians - The PROCURE project
Poster:
24P
First Author:
Giuseppe Curigliano, M.D., Ph.D.,
IEO - Istituto Europeo di Oncologia, Milan, Italy
The first poster will present findings from a prospective study
conducted at the University Hospital of Salamanca (Spain),
evaluating the influence of the PAM50 gene signature, the
foundation of the Prosigna assay, on therapeutic decision-making
for 143 patients with early-stage breast cancer.
The second poster will feature initial findings and consensus
from the first wave of the PROCURE (Prosigna Clinical Utility
Review) project, a European study utilizing the Delphi methodology
to generate consensus regarding the clinical utility of genomic
tests, including the Prosigna Breast Cancer Gene Signature Assay,
in breast cancer treatment. The study is led by an independent
scientific committee of eight breast cancer experts with input from
141 breast cancer clinicians practicing in nearly a dozen European
countries.
About Prosigna
The Prosigna Breast Cancer Gene Signature Assay is a prognostic
genomic test, built from PAM50 molecular subtypes, which combines
tumor gene expression with clinicopathologic factors to better
inform treatment decisions. The assay is indicated in female breast
cancer patients who have undergone either mastectomy or
breast-conserving therapy in conjunction with locoregional
treatment consistent with standard of care, either as a prognostic
indicator for distant recurrence-free survival at 10 years in
post-menopausal women with Hormone Receptor-Positive (HR+), lymph
node-negative, Stage I or II breast cancer, or lymph node-positive
(1–3 positive nodes, or 4 or more positive nodes), Stage II or IIIA
breast cancer to be treated with adjuvant endocrine therapy alone,
when used in conjunction with other clinicopathological factors.
Outside of the United States, the Prosigna Breast Cancer Gene
Signature Assay also provides the intrinsic subtypes of the tumor
tissue within three groups, low, intermediate and high, by the
nCounter Analysis System through decentralized performance.
The Prosigna test is FDA 510(k) cleared in the United States for
use on the nCounter Analysis System and is available for use when
ordered by a physician. The Prosigna test has received CE Mark and
is available for use by healthcare professionals in the European
Union and other countries that recognize the CE Mark, as well as in
Canada, Israel, Australia, New Zealand and Hong Kong. The assay is
covered by Medicare and leading private payers in the United
States, and is widely covered by government and private payers in
the countries where it is available.
About Veracyte
Veracyte (Nasdaq: VCYT) is a global genomic diagnostics company
that improves patient care by providing answers to clinical
questions, informing diagnosis and treatment decisions throughout
the patient journey in cancer and other diseases. The company’s
growing menu of genomic tests leverage advances in genomic science
and technology, enabling patients to avoid risky, costly diagnostic
procedures and quicken time to appropriate treatment. The company’s
tests in lung cancer, prostate cancer, breast cancer, thyroid
cancer, bladder cancer and idiopathic pulmonary fibrosis are
available to patients and its lymphoma subtyping and renal cancer
tests are in development. With Veracyte’s exclusive global license
to a best-in-class diagnostics instrument platform, the company is
positioned to deliver its tests to patients worldwide. Veracyte is
based in South San Francisco, California. For more information,
please visit www.veracyte.com and follow the company on Twitter
(@veracyte).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to, our statements related to our plans,
objectives, expectations (financial and otherwise) or intentions
with respect to the Prosigna Breast Cancer Gene Signature Assay.
Forward-looking statements can be identified by words such as:
"anticipate," "intend," "plan," "expect," "believe," "should,"
“suggest,” "may," "will" and similar references to future periods.
Actual results may differ materially from those projected or
suggested in any forward-looking statements. Examples of
forward-looking statements include, among others, statements
regarding Veracyte’s belief that the PAM50 gene signature and the
Prosigna assay provide clinical value that help clinicians make
therapeutic decisions. These statements involve risks and
uncertainties, which could cause actual results to differ
materially from our predictions, and include, but are not limited
to: Veracyte’s ability to achieve and maintain Medicare coverage
for its tests; the benefits of Veracyte’s tests and the
applicability of clinical results to actual outcomes. Additional
factors that may impact these forward-looking statements can be
found under the caption “Risk Factors” in our Annual Report on Form
10-K filed with the SEC on February 22, 2021 and our subsequent
quarterly reports on Form 10-Q. A copy of these documents can be
found at the Investors section of our website at www.veracyte.com.
The risks and uncertainties may be amplified by the COVID-19
pandemic, which has caused significant economic uncertainty. The
extent to which the COVID-19 pandemic impacts Veracyte’s
businesses, operations, and financial results, including the
duration and magnitude of such effects, will depend on numerous
factors, which are unpredictable, including, but not limited to,
the duration and spread of the outbreak, its severity, the actions
to contain the virus or treat its impact, and how quickly and to
what extent normal economic and operating conditions can resume.
These forward-looking statements speak only as of the date hereof
and, except as required by law, Veracyte specifically disclaims any
obligation to update these forward-looking statements or reasons
why actual results might differ, whether as a result of new
information, future events or otherwise.
Veracyte, Afirma, Percepta, Envisia, Prosigna, "Know by Design"
and the Veracyte, Afirma, Percepta, Envisia and Prosigna logos are
registered trademarks of Veracyte in the U.S. and selected
countries.
nCounter is the registered trademark of NanoString Technologies,
Inc. in the United States and other countries and used by Veracyte
under license.
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version on businesswire.com: https://www.businesswire.com/news/home/20210504006296/en/
Investor and Media Contact: Tracy Morris Vice President
of Corporate Communications & Investor Relations
tracy.morris@veracyte.com 650-380-4413
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