RNA whole-transcriptome and machine learning platform enables genomic
test to distinguishbenign Hürthle cells, reducing potential for
unnecessary surgeries
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Apr. 8, 2019--
Veracyte,
Inc. announced today that a new study published online in BMC
Systems Biology showcases the development of the Afirma®
Genomic Sequencing Classifier (GSC) and its ability to distinguish
benign from likely-cancerous Hürthle cells, a common, but
difficult-to-diagnose thyroid nodule subtype. The Afirma GSC was
developed using Veracyte’s novel RNA whole-transcriptome sequencing and
machine learning platform. Most Hürthle cell cases yield inconclusive
cytopathology results and, prior to Veracyte’s next-generation genomic
test, most of these patients typically required surgery to rule out
thyroid cancer.
“While most Hürthle cells in patients with indeterminate thyroid nodules
are benign, patients with this thyroid nodule subtype have historically
been recommended for surgery because of the possibility of cancer,” said
Richard T. Kloos, M.D., senior medical director – endocrinology, at
Veracyte. “Our novel science and technology platform enables the Afirma
GSC to distinguish benign Hürthle cells and thus help rule out the need
for surgery for many of these patients.”
The new paper details the Afirma GSC’s development and includes
previously reported clinical validation findings showing that the Afirma
GSC’s ability to identify benign Hürthle-cell nodules increased by
nearly five-fold compared to Veracyte’s original Afirma Gene Expression
Classifier (GEC). The next-generation test also maintains the flagship
Afirma test’s high sensitivity (91 percent), while identifying 30
percent more benign nodules (68 percent specificity) – regardless of
thyroid subtype.
“This new paper supports the real-world results that we have observed in
our practice since we began using the Afirma GSC in August 2017,” said
R. Mack Harrell, M.D., of the Memorial Center for Integrative Endocrine
Surgery in Boca Raton, Fla. “We recently reported that, among
Hürthle-cell dominant thyroid nodules, which comprise about 20 percent
of all indeterminate nodules in our practice, the Afirma GSC has
significantly increased the number of benign nodules that we’ve
identified. Using the Afirma GSC test allows us to send 45 percent fewer
patients to surgery, compared to the original Afirma GEC test, for an
absolute reduction in surgeries of 25 percent. This is great news for
our patients and for the healthcare system.”
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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190408005149/en/
Source: Veracyte, Inc.
Angie McCabe
Vice President, Investor Relations & Corporate
Communications
650-243-6371
angie@veracyte.com