Genzyme and Veracyte Announce Global Co-Promotion Agreement

The arrangement will give patients worldwide increased access to an advanced personalized medicine solution for improved diagnosis of thyroid nodules, and the potential to significantly reduce the number of unnecessary thyroidectomies.

Under terms of the agreement, Genzyme will market and promote Veracyte's Afirma(R) Thyroid FNA Analysis, an innovative and novel approach for improved thyroid nodule diagnosis, in the United States and, subsequently, in global markets. Financial terms of the deal were not disclosed.

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 fine needle aspirations (FNAs) -- a minimally invasive procedure to extract suspicious 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 of these patients undergo thyroid resection for a definitive diagnosis, given that thyroid cancer is highly treatable. Post-surgical results, however, show that only 20-30 percent of these patients have cancer.

Veracyte's novel solution combines expert cytopathology assessment of thyroid nodule FNA samples, with the company's Afirma Gene Expression Classifier used to resolve indeterminate results and thus help patients with benign nodules avoid unnecessary surgery. Two independent clinical studies -- both part of a large, multicenter, prospective clinical trial involving academic and community sites -- 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. Veracyte announced recently that its Afirma Gene Expression Classifier has been granted coverage for Medicare patients nationwide.

Thyrogen (developed and marketed by Genzyme) 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.

"This partnership is a strong fit for both companies and underscores Genzyme's commitment to improving the quality of care for patients with suspected or diagnosed thyroid cancer," said Genzyme's Head of Rare Diseases, Rogerio Vivaldi, M.D. "Together, our products offer patients and physicians a powerful personalized medicine solution for the diagnosis and treatment of thyroid cancer, addressing an unmet need in the community and improving patient outcomes."

"We are delighted to join forces with Genzyme," said Bonnie Anderson, Veracyte's Cofounder and CEO. "This powerful partnership will enable us to utilize Genzyme's specialized endocrinology sales force and marketing infrastructure to commercialize our Afirma Thyroid FNA Analysis more quickly in the U.S. and globally. In addition to benefitting patients, our solution will improve the cost-effectiveness of thyroid nodule diagnosis worldwide."

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.