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Veracyte, Genzyme Co-marketing Thyroid Dx Tool

NEW YORK (GenomeWeb News) – Genzyme and Veracyte today announced a co-marketing deal covering Veracyte's thyroid diagnostic tool.

Under the terms of the deal, Genzyme will market and promote Veracyte's Afirma Thyroid FNA Analysis solution in the US initially and then globally. Other terms were not disclosed.

Veracyte's solution combines cytopathology assessment of thyroid nodule fine needle aspiration (FNA) samples and the company's Afirma Gene Expression Classifier to resolve indeterminate results and spare patients with benign nodules unnecessary surgery.

Two independent clinical studies have demonstrated that the Afirma Gene Expression Classifier can reclassify patients with indeterminate thyroid FNA results as benign with the same accuracy as a benign cytopathology diagnosis, Genzyme and Veractye said.

Medicare recently began coverage of the Afirma Gene Expression Classifier nationwide. A recent economic impact study also determined that the product would prevent tens of thousands of avoidable surgeries in the US each year and save more than $600 million in direct medical savings during a five-year period.

Genzyme, a Sanofi company, markets Thyrogen for patients for well-differentiated thyroid cancer. In a statement, Rogerio Vivaldi, the company's head of rare diseases, said that the firms' products provide patients and doctors "a powerful personalized medicine solution for the diagnosis and treatment of thyroid cancer, addressing an unmet need in the community and improving patient outcomes."

Thyroid cancer is the fastest-growing cancer in the US with 56,460 new cases expected in 2012, Genzyme and Veracyte said, citing statistics from the American Cancer Society. About 450,000 thyroid nodule FNAs are performed annually in the US to rule out cancer, they added.

Interpreting results from such FNAs can be difficult, however, and up to 30 percent of cases yield ambiguous results. Current guidelines recommend that patients undergo thyroid resection for a definitive diagnosis.