Veracyte Announces that New Data from Multiple Studies Demonstrate “Real World” Performance of Afirma GSC and Xpression Atlas in Thyroid Cancer Diagnosis

Study findings reported at the American Thyroid Association Annual
Meeting

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte,
Inc.
(Nasdaq: VCYT) announced today that new findings from six
studies reinforcing the “real world” performance of the next-generation
Afirma Genomic Sequencing Classifier (GSC) and the Afirma Xpression
Atlas in thyroid cancer diagnosis were presented at the 88th
Annual Meeting of the American Thyroid Association (ATA). The meeting is
being held October 3-7 in Washington, D.C.

Researchers from leading institutions presented posters showing that use
of the Afirma GSC at their respective centers significantly increased
the identification of benign thyroid nodules among those deemed
indeterminate – not clearly benign or malignant – following
cytopathology review, compared to the original Afirma test.

  • The Ohio State University – Researchers compared results of 113
    indeterminate samples that were tested with the Afirma GSC to those of
    403 samples using the earlier version of the test (the Afirma Gene
    Expression Classifier, or GEC). The Afirma GSC identified 74.1 percent
    of the nodules as benign, compared to 48.4 percent with the GEC, an
    increase of 53 percent. The overall surgery rate among all patients
    who underwent genomic testing decreased by more than half – from 42.2
    percent with the GEC to 20.2 percent with the GSC.
  • Cleveland Clinic – Comparing results of 46 samples tested with the
    Afirma GSC between July 2017 and December 2017 with 182 samples tested
    with the original test between December 2011 and July 2017,
    researchers found that the GSC identified 67.4 percent as benign,
    compared to 41.8 percent with the GEC – an increase of 61 percent. The
    overall surgery rate for nodules tested with the GSC was 32.6 percent,
    compared to 47.3 percent with the original test, a decrease of 31
    percent.
  • Brigham and Women’s Hospital – Researchers evaluated results for 583
    thyroid nodules tested with either the Afirma GSC (n=97) or GEC
    (n=486) between 2011 and 2018. They found that the Afirma GSC
    identified 64.9 percent of nodules as benign, compared to 47.9 percent
    with the GEC, an increase of 35 percent.

“Our results show that with the improved testing, we sent significantly
fewer patients to surgery,” said Dr. Christian Nasr, medical director of
the Thyroid Center in the Endocrinology & Metabolism Institute at
Cleveland Clinic in Cleveland, Ohio. “Additionally, when patients went
to surgery following ‘suspicious’ results, we were more likely to find
cancer. Our findings suggest that the next-generation test can help more
patients avoid unnecessary thyroid surgery, while focusing healthcare
resources on the patients who are more likely to need them.”

Additionally, in two oral presentations, researchers shared the first
“real world” Afirma Xpression Atlas data, providing insights into the
distribution of a wide range of gene variants and fusions across key
categories of indeterminate thyroid nodules and Afirma GSC results. For
example, among 13,549 indeterminate thyroid nodules evaluated using the
Afirma GSC and Xpression Atlas, more than a quarter (25.9 percent) of
GSC-suspicious nodules (in primary risk categories known as Bethesda
III/IV) contained RAS variants. Additionally, RET, NTRK, BRAF and ALK
fusions were only found in GSC-suspicious, versus GSC-benign, cases (in
all Bethesda categories).

“Having detailed genomic information about thyroid nodules that are
malignant or suspicious for cancer may in some cases help inform
surgical decision-making for these patients,” said Dr. Allan C. Golding
of Memorial Healthcare System in Hollywood, Fla. “Additionally, the wide
range of gene alterations detected by the Xpression Atlas may provide
further insights into pathway activation and potential cancer treatment
targets for patients with thyroid cancer.”

The field of precision medicine is progressing rapidly, and multiple
targeted therapies are in clinical trials or have been approved for
treatment of advanced cancers that harbor specific genomic alterations.
In the new data presented at the ATA conference, genomic changes (or
alterations) targeted by these new therapies were identified in Afirma
GSC-suspicious cases by the Xpression Atlas.

“The new data shared at the ATA annual meeting add to the growing
library of real-world evidence demonstrating the Afirma GSC’s
performance across multiple institutions in reducing unnecessary
surgeries in thyroid cancer diagnosis,” said Bonnie Anderson, Veracyte’s
chairman and chief executive officer. “Additionally, these new study
data for the Afirma Xpression Atlas demonstrate the ability of our
robust RNA sequencing platform to provide rich genomic content that may
help inform surgery decisions and treatment options for patients with
suspected or confirmed thyroid cancer. The extensive gene alteration
data that it provides becomes increasingly important in the era of
targeted therapies.”

For more information, please visit the Veracyte Booth #201 or www.afirma.com/ATA2018.

About Afirma

Veracyte’s Afirma solution provides a comprehensive offering in thyroid
cancer diagnosis for physicians evaluating patients with thyroid
nodules. The Afirma Genomic Sequencing Classifier combines RNA
sequencing data with machine learning to identify patients with benign
thyroid nodules among those with indeterminate cytopathology results in
order to avoid unnecessary surgery and preserve the thyroid. Since the
commercial introduction of Afirma in 2011, Veracyte has performed over
100,000 genomic tests, and estimates it has saved more than 40,000
patients from unnecessary thyroid surgery and removed an estimated $800
million in surgery costs from the healthcare system. The Afirma
classifier is proven in over 20 published clinical studies, is included
in most leading clinical guidelines and is covered as medically
necessary by Medicare and all major U.S. health plans. The company’s
Afirma Xpression Atlas platform, introduced in May 2018, provides
extensive genomic data that may inform surgery strategy and treatment
options for patients with thyroid nodules that are suspicious for cancer
or cancerous. The RNA sequencing-based platform measures 761 DNA
variants and 130 RNA fusions in over 500 genes shown to be associated
with thyroid cancer on thyroid nodule fine needle aspiration samples.

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 and collectively target a $2 billion market
opportunity. 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, our belief that our
genomic tests will transform the diagnosis of thyroid cancer, lung
cancer and idiopathic pulmonary fibrosis; statements about the ability
of Afirma GSC to improve upon the original Afirma test; and statements
about the accuracy of the Xpression Atlas. Forward-looking statements
are neither historical facts nor assurances of future performance.
Instead, they are based only on our current beliefs, expectations and
assumptions regarding the future of our business, future plans and
strategies, anticipated events and trends, the economy and other future
conditions. Forward-looking statements involve risks and uncertainties,
which could cause actual results to differ materially, and reported
results should not be considered as an indication of future performance.
These risks and uncertainties include, but are not limited to: our
ability to achieve Medicare coverage for our tests, the market
opportunity for the Envisia classifier, the benefits of our tests, 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 sell our Afirma tests and successfully transition to our
next-generation Afirma GSC; 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 June 30, 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

Veracyte Media & Investor Contact:
Angie McCabe,
650-243-6371
Vice President, Investor Relations & Corporate
Communications
angie@veracyte.com

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