Afirma Testing Process

Physicians Collect and Send Thyroid Nodule FNA Samples
Using Afirma sample collection and transport supplies, physicians perform FNAs on patient thyroid nodules for cytopathology assessment and genomic analysis. The samples are sent via overnight courier to the Veracyte laboratory. Once received, patient samples and corresponding Afirma Requisition Forms are reviewed for accuracy. Any issues that arise are handled by the Veracyte Customer Care team.

TCP Cytopathologists Deliver Initial Diagnoses
Next, experts from Thyroid Cytopathology Partners (TCP) conduct thorough assessments of FNA samples submitted and generate a final cytopathology diagnosis. For diagnoses that are definitively either benign or malignant, the Afirma Thyroid FNA Analysis is complete and final patient reports are delivered to the treating physicians. A TCP pathologist routinely calls the ordering physician when the results are malignant or complex.

View a sample patient report showing a traditional cytopathology final diagnosis.

Nodules with Indeterminate* Diagnoses by Cytopathology are tested with the Afirma Genomic Sequencing Classifier (GSC)
Veracyte uses the Afirma Genomic Sequencing Classifier to determine if the nodule, diagnosed as indeterminate* by cytopathology, is either benign1 or suspicious for malignancy. Subsequently, a final patient report is delivered to the treating physician, containing both the cytopathology and Genomic Sequencing Classifier diagnoses for each nodule and a summary for the patient.

View a sample patient report showing an indeterminate cytopathology diagnosis with the Afirma Genomic Sequencing Classifier result.

Patient Case Review
While it is standard practice for TCP cytopathologists to call treating physicians when diagnoses are malignant, TCP cytopathologists are available to discuss any patient cases by phone. Contact Veracyte Customer Care at 1.888.9AFIRMA (888.923.4762) or to arrange a consultation.

* Indeterminate includes follicular lesion of undetermined significance (FLUS)/atypia of undetermined significance (AUS) and (suspicious for) follicular/Hürthle neoplasm
** Negative predictive value

1. Patel, JAMA Surgery 2018