Afirma Genomic Sequencing Classifier (GSC)

Casandra

Casandra Test Code VE66554Version 1 (DRAFT)

Performing Lab

Lab VeracyteLab Test ID N/A

Afirma Genomic Sequencing Classifier (GSC)

Clinical Use

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

The Afirma GSC test is available to clinicians and patients in the US and is performed in Veracyte’s CLIA-certified laboratory. It is covered by Medicare and most private payers, extending coverage as a benefit to approximately 275 million people. The test can also be made available outside the US on a case-by-case basis.

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.

Test Details

Methodology

NGS (WTS)

Biomarkers

The Afirma Genomic Sequencing Classifier utilizes RNA whole-transcriptome sequencing combined with machine learning technology to evaluate thyroid nodules. It identifies nodules as benign or suspicious for cancer, providing gene mutation information useful in guiding treatment decisions.