New Findings Presented at 2019 ASCO Annual Meeting
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jun. 1, 2019--
Veracyte,
Inc. (Nasdaq: VCYT) today announced new data demonstrating the
potential for its Afirma® Xpression Atlas (XA) genomic test
to guide targeted treatment selection for patients with a rare but
aggressive form of thyroid cancer concurrent with diagnosis by the
company’s Afirma Genomic Sequencing Classifier (GSC).
The findings advance physicians’ ability to answer multiple clinical
questions for their thyroid patients using a single, minimally invasive
sample. They were presented today at the American Society of Clinical
Oncology (ASCO) Annual Meeting, which is being held May 31-June 4, 2019
in Chicago.
Researchers used the Afirma XA to conduct RNA sequencing on 90 thyroid
fine needle aspiration samples that had been diagnosed with medullary
thyroid cancer (MTC) through the Afirma GSC. The cohort was derived from
nearly 30,000 sequential samples that were indeterminate or suspicious
for cancer following traditional cytopathology testing. The researchers
found that the Afirma XA identified a gene variant or fusion in 74
percent of the MTC cases and that 99 percent of these cases had one or
more variants or fusions – RET, KRAS, HRAS and/or BRAF
alterations – that are targeted by new therapies that are
currently in clinical trials or early stage development.
“With the emergence of new molecularly targeted therapies for medullary
thyroid cancer, molecular testing to identify the driver genomic
mutations will be key to optimizing patient outcomes,” said Lori J.
Wirth, M.D., medical director of the Center for Head and Neck Cancers at
Massachusetts General Hospital, who presented the findings in a poster
session today. “The potential to select targeted therapy at the time of
diagnosis may be especially helpful for patients with advanced disease.”
The Afirma GSC and Xpression Atlas provide physicians with a
comprehensive solution for a complex landscape in thyroid nodule
diagnosis and individualization of care. Veracyte developed the Afirma
GSC with RNA whole-transcriptome sequencing and machine learning. The
test helps identify patients with benign thyroid nodules among those
with indeterminate cytopathology results in order to help patients avoid
unnecessary diagnostic thyroid surgery, while also identifying patients
with MTC. The Afirma XA 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 XA includes 761 DNA variants and 130 RNA fusion partners in
over 500 genes that are associated with thyroid cancer.
“These new data show that our comprehensive Afirma solution can not only
help patients avoid unnecessary diagnostic surgery when their nodules
are benign, but may also inform targeted therapy selection when thyroid
cancer is diagnosed,” said Bonnie Anderson, Veracyte’s chairman and
chief executive officer. “These findings represent a significant step
forward in delivering on the promise of precision medicine for thyroid
cancer patients.”
About Thyroid Cancer
The American Cancer Society estimates that 54,070 people in the United
States will be diagnosed with thyroid cancer this year. Medullary
thyroid cancer, which is more difficult to find and treat, makes up
approximately 4 percent of all thyroid cancers. Each year in the United
States approximately 525,000 patients undergo FNA biopsies to evaluate
thyroid nodules for cancer. Up to 30 percent of these patients receive
indeterminate results – meaning they are not clearly benign or malignant
– and, historically, most were directed to diagnostic surgery even
though 70 percent to 80 percent of the time the nodules ultimately
proved to be benign.
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 five 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 quarterly report on Form 10-Q for the quarter
ended March 31, 2019. 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