Veracyte today announced that new clinical validation data published online in Thyroid show that the company’s RNA sequencing-based Afirma Medullary Thyroid Cancer (MTC) Classifier demonstrated high sensitivity and specificity in identifying MTC among pre-operative thyroid nodule fine needle aspiration (FNA) biopsy samples. The findings suggest that the genomic test may enable more timely diagnosis of this rare but aggressive form of thyroid cancer, compared to traditional methods, thus potentially expediting time to appropriate treatment.
The Afirma MTC Classifier is included as part of the Afirma testing offering on all orders for patients with thyroid nodules that are deemed indeterminate or suspicious for cancer based on cytopathology evaluation.
“MTC is often difficult to distinguish using traditional cytopathology,” said Joshua Klopper, M.D., Veracyte’s medical director for endocrinology and an author of the study. “However, knowing that a patient has this potentially aggressive type of thyroid cancer before surgery is important so that the physician can plan the surgery appropriately. Our findings show that the Afirma MTC Classifier identifies MTC on pre-operative samples with high accuracy, which may optimize patient outcomes.”
For the study, researchers evaluated the Afirma MTC’s performance on a blinded cohort of 211 pre-operative thyroid FNA samples with subsequent surgical pathology, including 21 MTC samples and 190 non-MTC samples that included both benign and malignant thyroid lesions. They found that the classifier accurately identified all 21 MTC cases (100 percent sensitivity) and all 190 non-MTC cases (100 percent specificity).
“These new data further reinforce the value that Afirma testing can offer in providing a clear diagnosis of MTC, which is so important for appropriate thyroid and nodal surgery to be done,” said Gregory W. Randolph, M.D., director of the Thyroid and Parathyroid Endocrine Surgical Division at Mass Eye and Ear, professor at Harvard Medical School, and lead author on the study.
Source – BusinessWire