Afirma Genomic Sequencing Classifier (GSC)
Use
The Afirma Genomic Sequencing Classifier (GSC) is used in thyroid nodule assessment to help patients avoid unnecessary diagnostic surgeries and inform treatment decisions. It helps rule out cancer in thyroid nodules when traditional test results are inconclusive. The test provides actionable information about tumor genes, guiding treatment decisions for patients with suspected or diagnosed thyroid cancer. Afirma GSC is performed on the same fine needle aspiration (FNA) sample used for initial cytopathology review and identifies nodules as benign or suspicious for cancer.
Special Instructions
Not provided.
Limitations
The Afirma GSC is not cleared or approved by the FDA. The test's performance is supported by clinical studies, including a published meta-analysis, demonstrating high sensitivity and negative predictive value. However, the explicit limitations concerning analytical performance, intended use conditions, and possible immunogenicity or cross-reactivity with other conditions are not detailed in the available content.
Methodology
NGS (WTS)
Biomarkers
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Performed on the same fine needle aspiration (FNA) sample used for initial cytopathology review.
Other tests from different labs that may be relevant