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Veracyte Announces Medicare Coverage for Its Afirma® Gene Expression Classifier for Improved Thyroid Nodule Diagnosis
Date:1/9/2012

of the first molecular diagnostics tests to be granted Medicare coverage under Palmetto GBA's new Laboratory and Molecular Diagnostics Services Program. The initiative requires companies seeking Medicare coverage for such tests to register them and submit evidence of their clinical utility and effectiveness.

"Palmetto GBA's coverage of the Afirma Gene Expression Classifier demonstrates our commitment to ensuring that the molecular diagnostics tests we cover provide a proven clinical benefit to Medicare patients," said Elaine Jeter, M.D., medical director of Palmetto GBA. "We also believe that a more consistent and transparent approach to reimbursement will help to further drive innovation in the rapidly growing molecular diagnostics field."

Veracyte's gene expression test has been shown in two independent studies – both part of a large, multicenter, prospective clinical trial involving academic and community sites – to be able to reclassify patients with indeterminate thyroid FNA results as "benign" with the same degree of accuracy as a benign diagnosis by cytopathology. Additionally, researchers from the Johns Hopkins University School of Medicine concluded recently that routine use of the Afirma Gene Expression Classifier on patients with indeterminate thyroid nodule FNA results would prevent tens of thousands of unnecessary surgeries each year and would provide more than $600 million in direct medical savings over five years in the U.S. Their findings were published recently in the Journal of Clinical Endocrinology & Metabolism.

Veracyte began commercializing its genomic test in late 2010 as part of its comprehensive Afirma Thyroid FNA Analysis offering. This comprehensive approach to thyroid nodule diagnosis combines expert cytopathology assessment by Veracyte's partner, Thyroid Cytopathology Partners, with the company's Afirma Gene Expression Classifier used to clarify inconclusive thyroid FNA results as benign or su
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SOURCE Veracyte, Inc.
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