SOUTH SAN FRANCISCO, Calif.,
May 18, 2017 /PRNewswire/ --
Veracyte, Inc. (NASDAQ: VCYT), a genomic diagnostics company
focused on reducing unnecessary surgeries and healthcare costs by
resolving diagnostic uncertainty, today announced that Anthem,
Inc., an independent Blues plan and one of the nation's largest
health benefits companies, has issued a positive coverage
policy for Veracyte's Afirma Gene Expression Classifier (GEC)
for use in thyroid cancer diagnosis. The policy renders the genomic
test a medically necessary benefit for Anthem's approximately 40
million members, effective immediately. The Afirma GEC is the only
genomic test for use in thyroid cancer diagnosis to receive such a
designation in the plan's new coverage policy.
The Afirma GEC is used to identify patients with benign thyroid
nodules among those whose fine needle aspiration (FNA) biopsy
results are indeterminate following traditional cytopathology
review, so that they may avoid an unnecessary diagnostic surgery.
The new policy brings the total number of covered lives for the
genomic test to more than 260 million, including over 110 million
Blues plan members. The Afirma GEC is now covered by Blues plans in
46 of the nation's 50 states.
"We are delighted that Anthem's members will now have access to
the Afirma test as a covered benefit," said Bonnie Anderson, Veracyte's chief executive
officer and chairman. "With this coverage decision, every major
health plan in the United States
now covers Afirma, which we estimate has helped save tens of
thousands of patients from unnecessary surgery since its
introduction in 2011. This is a significant corporate
milestone for us, as Afirma is one of the only tests in the genomic
diagnostics sector to achieve such broad coverage."
Each year in the United States,
more than 525,000 fine needle aspiration biopsies are
performed to assess patients with potentially cancerous thyroid
nodules. Up to 30 percent of the results are indeterminate (not
clearly benign or malignant) and physicians have traditionally
recommended thyroid surgery for a more definitive diagnosis.
Following surgery, however, 70 to 80 percent of patients' nodules
are diagnosed as benign, meaning the surgery was unnecessary. Such
surgery is invasive, costly and often leads to the need for
lifelong daily thyroid hormone replacement drugs.
The Afirma Gene Expression Classifier has become a new standard
of care in thyroid cancer diagnosis, where it is used to identify
patients with benign thyroid nodules among those with indeterminate
cytopathology results in order to preserve the thyroid. The Afirma
Genomic Sequencing Classifier (GSC), introduced in May 2017, is the next-generation version of the
Afirma GEC and combines RNA sequencing and machine learning for
enhanced performance. Clinical data demonstrate that the enhanced
test maintains the GEC's high sensitivity, while increasing its
specificity, to enable significantly more patients to avoid
unnecessary surgery as part of thyroid cancer diagnosis.
About Veracyte
Veracyte (NASDAQ: VCYT) is a
leading genomic diagnostics company that is fundamentally improving
patient care by resolving diagnostic uncertainty with evidence that
is trustworthy and actionable. The company's products uniquely
combine genomic technology, clinical science and machine learning
to provide answers that give physicians and patients a clear path
forward without risky, costly surgery that is 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 estimate of the number of
patients who have avoided unnecessary surgery, our beliefs with
respect to coverage levels for our test, our belief that our test
is becoming the standard of care, and our beliefs regarding the
significance of the coverage decision to our business and business
strategy. 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: demand for our tests, the
applicability of clinical results to actual outcomes; laws and
regulations applicable to our business, including potential
regulation by the Food and Drug Administration or other
regulatory bodies; the size of the market opportunity for our
products; 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 timing and publication of
clinical study results; and other risks set forth in the company's
filings with the Securities and Exchange Commission, including
the risks set forth in the company's Quarterly Report on Form 10-Q
for the quarter ended March 31, 2017. These forward-looking
statements speak only as of the date hereof
and Veracyte specifically disclaims any obligation to
update these forward-looking statements.
Veracyte, Afirma, Percepta, Envisia, the Veracyte logo, and the
Afirma logo are trademarks of Veracyte, Inc.
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SOURCE Veracyte