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Genzyme and Veracyte announce global co-promotion agreement to deliver personalized solution for thyroid patients
Genzyme, one of the world’s leading biotechnology companies, and Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, today announced a global co-promotion partnership to provide a comprehensive solution for thyroid patients. 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® 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% 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.
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.
"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.
Philadelphia Couple Raises Money for Thyroid Cancer Research
“When I heard Dr. Mandel talk about her team’s research and the way it could improve care for thyroid cancer patients like me, I knew I had to get involved,” said Ellen Fishman, a thyroid cancer survivor.
Ms. Fishman was already working to make a difference for thyroid cancer survivors through the help of Joan Shey, founder of the Light of Life Foundation, a non-profit dedicated to thyroid cancer research and patients. Together, Ms. Fishman and Ms. Shey organized a gala in the spring to raise money for thyroid cancer research.
Ms. Fishman had met Dr. Susan Mandel, MD, MPH, a professor at the Hospital of the University of Pennsylvania, at an Abramson Cancer Center conference, where patients, families, and survivors learned about thyroid cancer from experts on the Penn Medicine faculty. In addition to becoming an advocate, Ms. Fishman decided to switch her care to HUP and direct the proceeds from the gala to support Dr. Mandel’s research.
Because of the gala’s success, Ellen and her husband, Harris, were able to join the Light of Life Foundation to present a check for $25,000 to Penn Medicine for Dr. Mandel’s research on July 13. Dr. Mandel has been researching new approaches to thyroid cancer follow up in patients at both low and high risk for thyroid cancer recurrence.
Funding for fellows as well as faculty is essential. Dr. Gabe Smolarz, MD, MSB, CCD, a fellow in Dr. Mandel’s group, recently conducted a promising clinical research project funded by donors like the Fishman family and Light of Life Foundation. He studied recurrence rates for patients with low-risk thyroid cancer and concluded that long-term invasive testing is not required for these patients, saving time and money for both patients and physicians.
Said Ms. Fishman, “We plan to hold the gala every year. Investing in this research is investing in a better future for so many local families.”
Read more at Penn-Medicine.