- Testing by Afirma GSC and Afirma XA helps reduce unnecessary
surgeries and inform disease treatment -
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jun. 17, 2019--
Veracyte,
Inc. (Nasdaq: VCYT) announced today that a review article in Cancer
Cytopathology, a journal of the American Cancer Society,
details how new RNA whole-transcriptome sequencing-based genomic testing
is helping physicians overcome a range of challenges in the diagnosis
and treatment of thyroid cancer. The article describes how the
technology behind Veracyte’s Afirma® Genomic Sequencing
Classifier (GSC) and Xpression Atlas (XA) is helping to reduce
unnecessary surgeries in thyroid cancer diagnosis, and also inform
surgery and treatment decision-making using the same minimally invasive
patient sample. The article is highlighted on the cover of the June
print issue, which is scheduled to be available the week of June 17,
2019.
Challenges involved in the management of thyroid nodules include:
Differentiating benign from malignant thyroid nodules when cytopathology
results are indeterminate; determining the extent of initial thyroid
surgery needed; and identifying targeted treatments for patients with
thyroid cancers that do not respond to standard treatment.
“New advances in genomic technology and our understanding of the genomic
underpinnings of thyroid disease are changing the landscape for how
physicians diagnose and treat patients with thyroid nodules and cancer,”
said William C. Faquin, M.D., Ph.D., pathologist at Massachusetts
General Hospital and Editor-in-Chief of Cancer Cytopathology. “In
the last 10 years, physicians have increasingly used genomic testing to
help reduce unnecessary thyroid surgeries when the cytopathology sample
is indeterminate for cancer. Now, genomic technology can identify gene
mutation drivers of disease to inform the type of surgery to be
performed. Increasingly, molecular testing may also help guide the use
of targeted therapies that are available or in development for patients
who do not respond to standard treatment.”
The article, titled “Extending Expressed RNA Genomics from Surgical
Decision Making for Cytologically Indeterminate Thyroid Nodules to
Targeted Therapies for Metastatic Thyroid Cancer,” describes the
development of and evidence behind the Afirma GSC and XA. Both tests
leverage RNA whole-transcriptome sequencing technology to measure gene
expression in potentially cancerous thyroid nodules. The authors note
that RNA transcriptome technology may provide advantages over DNA-based
genomic findings because it reflects a nodule’s current genomic
activity, as compared to DNA-based approaches, which may show inactive
gene mutations.
Two targeted therapies are now approved by the U.S. Food and Drug
Administration for treating thyroid cancer patients: a combination of
dabrafenib plus trametinib for BRAF V600E-mutated anaplastic
thyroid cancer; and larotrectinib for solid tumors harboring a NTRK
gene fusion, regardless of cancer type. Additionally, multiple other
recent clinical trials have investigated therapies with specific targets
that are relevant for thyroid cancer. These include two compounds
targeting RET alterations, which were the subject of new data
presentations at the recent American Society of Clinical Oncology (ASCO)
Annual Meeting. The Afirma XA identifies these gene alterations, which
can help physicians determine which patients could benefit from these
cutting-edge new treatments.
“We believe that our novel RNA whole-transcriptome sequencing platform
uniquely enables our Afirma offering to answer important clinical
questions that can guide various points in a patient’s journey, helping
to improve outcomes,” said Bonnie Anderson, Veracyte’s chairman and
chief executive officer. “Further, by providing this comprehensive
information from the original biopsy used in diagnosis, we can
streamline workflows and enable patients to get the answers they need
faster and more easily.”
About Afirma Genomic Testing
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. Afirma GSC testing is widely
used in thyroid cancer diagnosis and is covered by Medicare and most of
the nation’s leading private health insurers. 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.
About Thyroid Cancer
The American Cancer Society estimates that 52,070 people in the United
States will be diagnosed with thyroid cancer this year. 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. These statements
involve risks and uncertainties, which could cause actual results to
differ materially from our predictions, and include, but are not limited
to statements about: the ability of Veracyte’s Afirma GSC to improve
upon the original Afirma GEC and to identify Hürthle cells, the ability
of Veracyte’s Afirma Xpression Atlas to help characterize medullary
thyroid cancer, 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; the
size of our addressable market; 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, 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