Findings Presented at ENDO 2019 Conference
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Mar. 25, 2019--
Veracyte,
Inc. (Nasdaq: VCYT) announced today that new data from the Afirma®
Xpression Atlas suggest that the majority of newly diagnosed medullary
thyroid cancers (MTC) are associated with variants from three genes. The
findings shed new light on the genomic underpinning of this rare, but
aggressive, form of thyroid cancer and were presented today at ENDO
2019, the Endocrine Society's annual meeting, which is being held March
23-26 in New Orleans.
“Our findings are important because they help us better understand the
genomic drivers of medullary thyroid cancer,” said Steven G. Waguespack,
M.D., professor of internal medicine and pediatrics at University of
Texas MD Anderson Cancer Center in Houston, who presented the new data
in a guided poster session. “Moreover, this information, derived from a
fine needle aspiration biopsy specimen, may help guide physicians in the
preoperative evaluation, surgical planning and targeted therapy
selection for patients diagnosed with this disease.”
For the study, researchers evaluated 77 preoperative fine needle
aspiration biopsies from thyroid nodules that were positive for MTC
based on Afirma testing and which spanned a range of Bethesda System
cytology classification categories (III-VI). All cases were subsequently
evaluated with the Xpression Atlas, which uses RNA whole-transcriptome
sequencing to detect 761 variants and 130 fusions in 511 genes that are
associated with thyroid cancer. The scientists found that among the MTC
cases, 55.8 percent harbored a RET variant, 9.1 percent included
a KRAS variant, 7.8 percent contained an HRAS variant
(some of which contained more than one of these gene alterations), while
2.6 percent of cases possessed fusions and 26.0 percent included no gene
variants or fusions.
“As more is understood about the genomic makeup of thyroid cancer
biology, physicians may be able to further refine their treatment plans
for patients using ever-more-granular genomic information,” said Giulia
C. Kennedy, Ph.D., chief medical and scientific officer at Veracyte. “We
believe that our Afirma offering – based on our whole-transcriptome
sequencing platform – is well-positioned to serve the needs of
physicians in the expanding era of precision medicine.”
About Afirma
The Afirma Genomic Sequencing Classifier (GSC) and Xpression Atlas
provide physicians with a comprehensive solution for a complex landscape
in thyroid nodule diagnosis. The Afirma GSC was developed with RNA
whole-transcriptome sequencing and machine learning and helps identify
patients with benign thyroid nodules among those with indeterminate
cytopathology results in order to help patients avoid unnecessary
diagnostic thyroid surgery. The Afirma Xpression Atlas provides
physicians with genomic alteration content from the same fine needle
aspiration samples that are used in Afirma GSC testing and may help
physicians decide with greater confidence on the surgical or therapeutic
pathway for their patients. The Afirma Xpression Atlas includes 761 DNA
variants and 130 RNA fusion partners in over 500 genes that are
associated with thyroid cancer.
About Veracyte
Veracyte (Nasdaq: VCYT) is a leading genomic diagnostics company that
improves patient care by providing trustworthy and actionable answers to
challenging clinical questions. The company's products uniquely combine
advanced genomic technology, clinical science and machine learning to
provide answers that give physicians and patients a clear path forward,
informing both diagnosis and treatment decisions without the need for
costly, risky surgeries that are often unnecessary. Since its founding
in 2008, Veracyte has commercialized three genomic tests, which are
transforming the diagnosis of thyroid cancer, lung cancer and idiopathic
pulmonary fibrosis. 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" within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements can be identified by words such as:
"anticipate," "intend," "plan," "expect," "believe," "should," "may,"
"will" and similar references to future periods. Examples of
forward-looking statements include, among others, the ability of
Veracyte’s Afirma Xpression Atlas to help characterize medullary thyroid
cancer, the ability of Veracyte’s Afirma GSC to identify Hürthle cells,
the expected impacts of Veracyte’s collaboration with Johnson & Johnson
in developing interventions for lung cancer, on Veracyte’s financial and
operating results, on the timing of the commercialization of the
Percepta classifier, and on the size of Veracyte’s addressable market.
Forward-looking statements are neither historical facts nor assurances
of future performance, but are based only on our current beliefs,
expectations and assumptions. These statements involve risks and
uncertainties, which could cause actual results to differ materially
from our predictions, and include, but are not limited to: our ability
to achieve milestones under the collaboration agreement with Johnson &
Johnson; our ability to achieve and maintain Medicare coverage for our
tests; the benefits of our tests and the applicability of clinical
results to actual outcomes; the laws and regulations applicable to our
business, including potential regulation by the Food and Drug
Administration or other regulatory bodies; our ability to successfully
achieve and maintain adoption of and reimbursement for our products; the
amount by which use of our products are able to reduce invasive
procedures and misdiagnosis, and reduce healthcare costs; the occurrence
and outcomes of clinical studies; and other risks set forth in our
filings with the Securities and Exchange Commission, including the risks
set forth in our annual report on Form 10-K for the year ended December
31, 2018. These forward-looking statements speak only as of the date
hereof and 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, except as required by law.
Veracyte, Afirma, Percepta, Envisia and the Veracyte logo are trademarks
of Veracyte, Inc.
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Source: Veracyte, Inc.
Investor and Media Contact:
Angie
McCabe
Vice President, Investor Relations & Corporate Communications
650-243-6371
angie@veracyte.com