ENDO: Gene-Expression Assay IDs Suspicious Thyroid Nodules
(HealthDay News) – A gene-expression classifier that measures expression of 167 genes correctly identifies suspicious thyroid nodules with high sensitivity.
Erik K. Alexander, MD, from Brigham and Women's Hospital and Harvard Medical School in Boston, and colleagues performed a 19-month, prospective validation study involving 49 clinical sites, 3,789 patients, and 4,812 fine-needle aspirates from thyroid nodules that needed evaluation. Performance of the gene-expression classifier was assessed on 265 indeterminate nodules from this cohort.
The researchers found that 85 of the indeterminate nodules were malignant. The classifier correctly identified 78 of these as suspicious (92% sensitivity, 52% specificity). The negative predictive values were 95% for atypia (or follicular lesions) of undetermined clinical significance, 94% for follicular neoplasms or lesions suspicious for follicular neoplasm, and 85% for suspicious cytologic findings. Six of the seven aspirates with false-negative results had a paucity of thyroid follicular cells.
"The study shows that a gene-expression classifier can be used to identify a subpopulation of patients with a low likelihood of cancer in a population of patients for whom diagnostic surgery is otherwise recommended," the authors write.
The study was funded by Veracyte; the authors disclosed financial ties to several biotechnology companies, including Veracyte.