NEW YORK (GenomeWeb News) – Veracyte and Genyzme today announced that the New York State Department of Health has cleared the way for Veracyte's molecular diagnostic test for inconclusive thyroid nodule results to be offered to patients in the state.
Memorial Sloan-Kettering Cancer Center will become one of the first institutions in the state to offer the test, which helps resolve inconclusive thyroid nodule results following traditional evaluation of fine needle aspiration (FNA) samples, the companies added.
The Afirma Gene Expression Classifier measures the expression of 142 genes to reclassify ambiguous thyroid FNA as either benign or possibly cancerous, and is offered as part of Veracyte's comprehensive Afirma Thyroid FNA Analysis, which combines an initial review based on cytopathology assessment of thyroid nodule FNAs with the Afirma test to resolve inconclusive results. The test is available through a global co-promotion partnership with Genzyme, a Sanofi company.
The test is CLIA certified, but New York requires an additional license from the New York State Department of Health for CLIA-certified tests to be offered to patients in the state. Afirma Gene Expression Classifier is now available in all 50 states, Veracyte Co-founder and CEO Bonnie Anderson said.
Veracyte received a positive Medicare decision for the test at the start of the year.
Citing statistics from the American Cancer Society, Veracyte, based in South San Francisco, Calif., said that thyroid cancer is the fastest growing cancer in the US with an estimated 56,460 new cases expected in 2012.