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New Data Suggest Veracyte's Molecular Test Improves Accuracy of Thyroid Nodule Diagnosis Using Fine Needle Aspirate (FNA) Samples
Date:9/15/2010

SOUTH SAN FRANCISCO, Calif.,  Sept. 15 /PRNewswire/ -- Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, announced that initial data from its large-scale, prospective, multi-center clinical trial were presented today at the 14th International Thyroid Congress, held in Paris, France. The findings showed that the company's molecular test classified inconclusive thyroid nodule fine needle aspirates (FNA) as benign with a high degree of accuracy, showing potential to help thousands of patients each year avoid surgery. These results demonstrate Veracyte's ability to use molecular testing to improve the diagnostic accuracy of FNA samples, enhancing the utility of this minimally invasive alternative to surgical diagnosis. Veracyte also announced that an article describing the company's rigorous scientific and clinical approach to development of its molecular test for use on cytology samples has been published online in the Journal of Clinical Endocrinology & Metabolism and will appear in the publication's December print issue.

In today's presentation at the International Thyroid Congress, lead author Bryan R. Haugen, M.D., Professor of Medicine and Pathology Head, Division of Endocrinology, Metabolism & Diabetes, at the University of Colorado, shared early data from the multi-center study, involving more than 40 community and academic sites. The researchers found that among 66 thyroid FNA samples, including 43 indeterminate samples, for which surgical pathology results were known, Veracyte's test had a negative predictive value (NPV) greater than 95 percent when compared to the gold standard of two blinded expert histopathology reviews. The multi-center clinical trial is ongoing, and results of the confirmatory performance study are expected to be published next year.

"A test with this high of a negative predictive value will help doctors rule out malignancy and confidently monitor man
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SOURCE Veracyte, Inc.
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