Veracyte, Inc. and Genzyme have announced that the New York State Department of Health has issued a license enabling Veracyte's Afirma® Gene Expression Classifier to be offered to patients in the state.
The companies also announced that Memorial Sloan-Kettering Cancer Center will become one of the first medical institutions in the state to offer patients the genomic test, which helps resolve inconclusive thyroid nodule results following traditional evaluation of fine needle aspiration (FNA) samples.
"We are delighted that the Afirma Gene Expression Classifier will now be available to physicians and their patients in New York State and that Memorial Sloan-Kettering is among the first in the state to offer our test," said Bonnie Anderson, Veracyte's cofounder and chief executive officer.
Anderson continued, "These milestones underscore the clinical need for and strength of the clinical data behind our test. Our goal is to help identify patients whose thyroid nodules are actually benign so that they may avoid unnecessary, invasive surgery."
Thyroid cancer is the fastest-increasing cancer in the United States, with 56,460 new cases expected in 2012, 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.
Up to 30% of the time, the results are inconclusive, and current protocols typically recommend thyroid surgery for final diagnosis. Following surgery, however, 70-80% of patients turn out to have benign nodules.
The Afirma Gene Expression Classifier measures the expression of 142 genes to reclassify ambiguous thyroid FNA samples as either benign or suspicious for cancer.
A clinical validation study, published recently in the New England Journal of Medicine, showed that when applied to the major categories of indeterminate thyroid samples, the test reclassified the samples as benign with greater than 94% accuracy.
The Afirma Gene Expression Classifier 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 now covered for Medicare patients nationwide and is available throughout the U.S. through a global co-promotion partnership with Genzyme, a Sanofi company and one of the world's leading biotechnology companies.
"We look forward to bringing to New York endocrinologists and thyroid patients a complete solution, which includes the Afirma Thyroid FNA Analysis for thyroid nodule assessment and Thyrogen® for the management of patients diagnosed with thyroid cancer," said Alicia Secor, Genzyme's vice president and general manager of Endocrinology.
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 in the follow up of patients with well-differentiated thyroid cancer.
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.