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Veracyte Announces UnitedHealthcare Coverage Policy For the Afirma® Gene Expression Classifier



   Veracyte Announces UnitedHealthcare Coverage Policy For the Afirma® Gene
                            Expression Classifier

PR Newswire

SOUTH SAN FRANCISCO, Calif., March 8, 2013

SOUTH SAN FRANCISCO, Calif., March 8, 2013 /PRNewswire/ -- Veracyte, Inc., a
molecular diagnostics company pioneering the emerging field of molecular
cytology, today announced that UnitedHealthcare, one of the nation's largest
private health insurers, has issued a positive medical coverage policy for the
Afirma® Gene Expression Classifier for use in assessing thyroid nodule fine
needle aspirate (FNA) biopsies that are indeterminate – not clearly benign or
malignant following traditional cytology review. The new medical coverage
policy will apply to the insurer's nearly 27 million commercial members,
effective April 1, 2013. Veracyte's genomic test is already covered for
approximately 40 million Medicare patients nationwide.

UnitedHealthcare's March 2013 Medical Policy Update Bulletin features an
update to its Gene Expression Testing  medical policy, which now includes the
Afirma Gene Expression Classifier as a proven test based on medical evidence.
The Afirma test is the only gene expression test to date to receive a "proven"
designation in the policy document, which is available on UnitedHealthcare's
website at https://www.unitedhealthcareonline.com. 

"We are pleased that this coverage decision will make Afirma more accessible
to thyroid nodule patients around the country," said Bonnie Anderson,
Veracyte's cofounder and chief executive officer. "Because of
UnitedHealthcare's leadership, more patients will be able to avoid unnecessary
thyroid surgeries, and healthcare costs for the management of indeterminate
thyroid nodules will be reduced."

The UnitedHealthcare policy decision is consistent with the National
Comprehensive Cancer Network (NCCN) Thyroid Carcinoma Guidelines, which
recommend that clinicians consider the use of molecular testing to identify
patients with indeterminate cytopathology results whose nodules are actually
benign and can thus avoid surgery. The Afirma Gene Expression Classifier is
the only molecular test clinically validated in prospective, multicenter,
double-blinded trials to meet the NCCN's validation benchmark to safely
monitor nodules in lieu of diagnostic surgery.

The Afirma Gene Expression Classifier measures the expression of 142 genes to
reclassify indeterminate thyroid FNA samples as either benign or suspicious
for cancer. The test is designed to help identify patients whose nodules are
actually benign and who can thus avoid unnecessary diagnostic surgery. An
additional 25 supplemental genes are used to improve classification of rare
cancer subtypes. The test is offered as part of Veracyte's comprehensive
Afirma Thyroid FNA Analysis, which combines specialized cytopathology
assessment for initial review of thyroid nodule FNAs, with the gene expression
test used to clarify inconclusive results. The test is available throughout
the U.S. through a global co-promotion partnership with Genzyme, a Sanofi
company.

Thyroid cancer is the fastest-increasing cancer in the United States, with
60,220 new cases expected in 2013, according to the American Cancer Society.
Approximately 450,000 thyroid nodule FNAs – a minimally invasive procedure to
extract cells for examination under the microscope – are performed each year
in the U.S. to rule out cancer. However, 15% to 30% of FNA biopsy results are
inconclusive, and most physicians recommend thyroid surgery for final
diagnosis. Following surgery, however, 70-80% of patients' nodules are
diagnosed as benign. These surgeries are invasive, expensive, and typically
result in lifelong thyroid hormone replacement therapy for the patient.

About Veracyte
Veracyte, Inc., based in South San Francisco, Calif., is a privately held
molecular diagnostics company pioneering the emerging field of molecular
cytology. The company discovers, develops and commercializes molecular
diagnostic solutions that enable physicians to make more informed treatment
decisions early, thus helping patients avoid unnecessary invasive procedures
while reducing healthcare costs. Veracyte's first product – the Afirma®
Thyroid FNA Analysis – combines specialized cytopathology assessment with the
Afirma Gene Expression Classifier, a genomic test that clarifies inconclusive
thyroid nodule results as benign or suspicious for cancer. The company has
formed a global co-promotion partnership with Genzyme, a Sanofi company, to
make the Afirma Thyroid FNA Analysis available throughout the U.S. and,
subsequently, globally. Veracyte is currently in the early biomarker discovery
phase for lung cancer and interstitial lung diseases. Veracyte is privately
held and funded by Domain Associates, Kleiner Perkins Caufield & Byers, TPG
Biotech and Versant Ventures. For more information, visit www.veracyte.com.

Veracyte and Afirma are registered trademarks of Veracyte, Inc. All rights
reserved.

SOURCE Veracyte, Inc.

Website: http://www.veracyte.com
Contact: Tracy Morris, +1-650-473-1272 (o), +1-650-380-4413 (c),
Tracy.Morris@veracyte.com
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