CAMBRIDGE, Mass. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Veracyte,
Inc., a molecular diagnostics company pioneering the emerging field
of molecular cytology, today announced that the Afirma®
Thyroid FNA Analysis, an innovative approach for improved thyroid nodule
diagnosis, is now available to patients across the United States.
“Now, the Afirma® Gene
Expression Classifier can potentially help tens of thousands of patients
with inconclusive thyroid nodules each year avoid unnecessary surgery
and improve patient outcomes.”
The Afirma® Thyroid FNA Analysis combines expert
cytopathology assessment of thyroid nodule fine needle aspiration (FNA)
samples, with the Afirma® Gene Expression Classifier, a novel
genomic test, used to resolve inconclusive results and thus help
patients whose nodules are actually benign avoid unnecessary surgery.
Two independent clinical studies to date have shown that the Afirma®
Gene Expression Classifier can reclassify patients with indeterminate
thyroid FNA results as “benign” with the same degree of accuracy as a
benign cytopathology diagnosis.
Thyroid cancer is the fastest-growing cancer in the U.S., with an
estimated 56,460 new cases expected in 2012, according to the American
Cancer Society. An estimated 450,000 thyroid nodule FNAs – a minimally
invasive procedure to extract cells for examination under a microscope –
are performed in the U.S. each year to rule out cancer. Thyroid nodule
FNAs are challenging to interpret, however, producing ambiguous results
in up to 30 percent of cases. Current guidelines recommend that most
patients with ambiguous results undergo thyroid resection for a
definitive diagnosis. Post-surgical results, however, show that only
20-30 percent of these patients have cancer.
“Until now, most patients with ‘indeterminate’ thyroid nodules based on
cytology went to surgery to help ensure that a cancer was not missed,”
said Dr. Bryan Haugen, professor of medicine and pathology at the
University of Colorado School of Medicine. “Now, the Afirma® Gene
Expression Classifier can potentially help tens of thousands of patients
with inconclusive thyroid nodules each year avoid unnecessary surgery
and improve patient outcomes.”
Genzyme is an established leader in endocrinology globally, developing
and marketing Thyrogen® (thyrotropin alfa for injection) for
patients with well-differentiated thyroid cancer. Thyrogen®
is used as an adjunctive diagnostic tool for serum thyroglobulin (Tg)
testing with or without radioiodine imaging. Thyrogen® is
also approved in the U.S. and Europe as an adjunctive treatment for
radioiodine ablation of thyroid tissue remnants in patients who have
undergone a near total or total thyroidectomy for well-differentiated
thyroid cancer and who do not have evidence of metastatic thyroid cancer.
“The addition of the Afirma® Thyroid FNA Analysis represents
a strong strategic fit for our Thyrogen business and addresses a
significant unmet need. The combined offering represents a complete
personalized solution that really advances thyroid nodule assessment and
the value of Thyrogen® in the management of patients
diagnosed with thyroid cancer,” said Genzyme’s VP and GM of
Endocrinology, Alicia Secor. “We expect many patients with thyroid
nodules will want to ask their physicians about the Afirma®
Thyroid FNA Analysis at the beginning of the diagnostic process.”
A recent economic impact study, published in the Journal of Clinical
Endocrinology & Metabolism, concluded that routine use of the
Afirma® Gene Expression Classifier in the U.S. would prevent
tens of thousands of avoidable surgeries each year and would provide
more than $600 million in direct medical savings over 5 years. The test
is now covered for Medicare patients nationwide.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative
therapies for patients affected by rare and debilitating diseases for
over 30 years. We accomplish our goals through world-class research and
with the compassion and commitment of our employees. With a focus on
rare diseases and multiple sclerosis, we are dedicated to making a
positive impact on the lives of the patients and families we serve. That
goal guides and inspires us every day. Genzyme’s portfolio of
transformative therapies, which are marketed in countries around the
world, represents groundbreaking and life-saving advances in medicine.
As a Sanofi company, Genzyme benefits from the reach and resources of
one of the world’s largest pharmaceutical companies, with a shared
commitment to improving the lives of patients. Learn more at www.genzyme.com.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops
and distributes therapeutic solutions focused on patients’ needs. Sanofi
has core strengths in the field of healthcare with seven growth
platforms: diabetes solutions, human vaccines, innovative drugs,
consumer healthcare, emerging markets, animal health and the new
Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
About Veracyte
Veracyte, Inc., based in South San Francisco, Calif., is pioneering the
emerging field of molecular cytology, applying molecular biomarkers to
cytology samples in order to improve disease diagnosis by clarifying
indeterminate results obtained from current methods. The company aims to
enable doctors to make more informed treatment decisions early, thus
improving patient care and providing cost savings to the healthcare
system. The company utilizes rigorous science and an extensive,
multicenter clinical program throughout discovery and development.
Veracyte’s first product – the Afirma Thyroid FNA Analysis – combines
expert cytopathology assessment with the Afirma Gene Expression
Classifier, a genomic test that clarifies inconclusive thyroid nodule
cytology results as benign or suspicious for cancer. The company 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.
Genzyme® and Thyrogen® are registered trademarks
of Genzyme Corporation. Veracyte® and Afirma® are
registered trademarks of Veracyte, Inc. All rights reserved.
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