Veracyte Announces New Publication of Data Demonstrating Real-World Performance of the Afirma GSC in Thyroid Cancer Diagnosis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte,
Inc
. (Nasdaq: VCYT) announced today that findings from a new
real-world study show that the company’s Afirma® Genomic
Sequencing Classifier (GSC) helps to identify significantly more benign
thyroid nodules and further reduce unnecessary surgeries in thyroid
cancer diagnosis, as compared to the original Afirma test. Findings from
the clinical utility study, conducted by researchers at The Ohio State
University, appear online in the journal Thyroid
and add to the growing body of independent evidence demonstrating the
performance of the next-generation genomic test.

In the study, researchers evaluated records for all patients whose
thyroid nodules were indeterminate for cancer based on cytopathology and
who subsequently underwent molecular testing with the Afirma GSC or the
original Afirma Gene Expression Classifier (GEC) between February 2011
and December 2018. Based on a cohort of 164 Afirma GSC-tested nodules
and 343 Afirma GEC-tested nodules, they found that the next-generation
test identified 58 percent more nodules as benign (76.2 percent vs. 48.1
percent) and that the rate of surgery among indeterminate thyroid
nodules decreased by 66.4 percent (from 52.5 percent with the Afirma GEC
to 17.6 percent with the Afirma GSC). The “benign call” rate among
Hürthle cells – a common but difficult-to-diagnose thyroid nodule
subtype – was also significantly higher using the Afirma GSC (88.8
percent vs. 25.7 percent).

“Our findings show that use of the Afirma GSC has enabled us to identify
many more patients as benign when their thyroid nodules were
indeterminate compared to the original test and, as a result, to help
significantly reduce unnecessary thyroid surgeries among these
patients,” said Jennifer A. Sipos, M.D., endocrinologist and professor
at The Ohio State University and an author of the new study. “The
next-generation test’s results were particularly striking for patients
with Hürthle cells who previously had little other choice than to
undergo diagnostic surgery, which carries risks and is costly.”

The new study marks the third recent independent publication by a major
medical center demonstrating that its use of the Afirma GSC helped to
significantly reduce surgeries in thyroid cancer diagnosis.

“These findings clearly demonstrate that, as compared to our original
test, our Afirma GSC is delivering even more value to patients who are
undergoing evaluation for thyroid cancer, as well as to physicians and
the healthcare system,” said Bonnie Anderson, Veracyte’s chairman and
chief executive officer. “This study further underscores the power of
our next-generation RNA whole-transcriptome sequencing and machine
learning platform to answer important clinical questions that help guide
a patient’s medical journey.”

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 commercially
introduced in 2017. 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. Clinical
validation data published in JAMA Surgery show that the
next-generation classifier maintains the original Afirma test’s high
sensitivity (91 percent), while identifying 30 percent more benign
nodules (68 percent specificity) among those deemed indeterminate by
cytopathology. 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 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.

Contacts

Investor and Media Contact:
Angie
McCabe
Vice President, Investor Relations & Corporate Communications
650-243-6371
[email protected]

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