Afirma GSC Test for Providers

Afirma GSC helps clinicians conclusively rule out surgery and confidently guide treatment for thyroid nodules.

Sample Reports How to Order
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Afirma has shown robust performance in validation studies and in the real-world setting

In a prospective, blinded, multicenter validation study:1

  • 91% sensitivity 
  • 96% negative predictive value
  • 68% specificity
  • 47% positive predictive value

In a meta-analysis of 13 different independent studies conducted in a real-world clinical setting:2

  • 97% sensitivity 
  • 99% negative predictive value
  • 88% specificity
  • 65% positive predictive value
  • 67% benign call rate
Inherited Risk Assessment
Screening and Risk Assessment
Diagnosis
Prognosis
Treatment Guidance
Recurrence Monitoring
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How the Afirma GSC test works

The Afirma GSC test uses whole-transcriptome-derived analysis of over 21,000 genes from your patient’s FNA sample to classify thyroid nodules and provide comprehensive molecular information for Bethesda III, IV, V, or VI specimens.1 

Bethesda III-IV

  • The test classifies the nodule as Benign or Suspicious.

  • If the nodule is classified as Suspicious, the test gives extra molecular information. This includes data from 593 genes, 905 variants, and 235 fusions.3  

  • If DNA analysis of the TERT promoter region (TERTp) is ordered, results from the TERTp DNA assay are also included for nodules classified as Suspicious.

Bethesda V-VI

  • No Benign or Suspicious classification is provided.  
  • The test provides additional molecular information from 593 genes, 905 variants, and 235 fusions.3
  • If DNA analysis of the TERT promoter region (TERTp) is ordered, results from the TERTp DNA assay are also included.

The impact of Afirma GSC on 100 patients with B-III/IV nodules

  • Conclusively rule out surgery
  • Absence of variant/fusion
  • Presence of variant/fusion
  • Confidently guide treatment 

Molecular testing is recommended in leading practice guidelines

2015 ATA Guidelines

“For nodules with AUS/FLUS cytology, after consideration of worrisome clinical and sonographic features, investigations such as repeat FNA or molecular testing may be used to supplement malignancy risk assessment in lieu of proceeding directly with a strategy of either surveillance or diagnostic surgery. Informed patient preference and feasibility should be considered in clinical decision-making.”

“Diagnostic surgical excision is the long-established standard of care for the management of FN/SFN cytology nodules. However, after consideration of clinical and sonographic features, molecular testing may be used to supplement malignancy risk assessment data in lieu of proceeding directly with surgery. Informed patient preference and feasibility should be considered in clinical decision-making.” 

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) 20256

“Molecular diagnostic testing to detect individual mutations (eg, BRAF V600E, RET/PTC, RAS, PAX8/PPAR gamma) or pattern recognition approaches using molecular classifiers may be useful in the evaluation of FNA samples that are indeterminate to assist in management decisions.”7-17

“Indeterminate groups include: 1) follicular or oncocytic neoplasms (Bethesda IV); and 2) AUS (Bethesda III).18-20 The NCCN Panel recommends consideration of molecular diagnostic testing for these indeterminate groups.”21,22

“Molecular diagnostic testing may include multigene assays or individual mutational analysis. In addition to their utility in diagnostics, molecular markers are beneficial for making decisions about targeted therapy options for advanced disease and for informing eligibility for some clinical trials. In addition, the presence of some mutations may have prognostic importance.”

Afirma GSC Resources

Afirma sample test reports

Molecular Only sample report

For patients with an indeterminate nodule that was found to be Benign by the Afirma test.

Download Sample Report

Molecular Only: Suspicious, BRAF K601E Positive sample report

For patients with an indeterminate nodule that was found to be Suspicious by the Afirma test.

Download Sample Report

Cytology + Molecular sample report

For patients diagnosed with an indeterminate nodule by Thyroid Cytopathology Partners, the Afirma test classified it as Benign.   

Download Sample Report

Cytology + Molecular: Suspicious, BRAF K601E Positive sample report

For patients diagnosed with an indeterminate nodule by Thyroid Cytopathology Partners, the Afirma test classified it as Suspicious.    

Download Sample Report

Afirma GSC insights

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How to order the Afirma GSC test

Ordering process

  • Supplies are available to collect and ship the FNA specimen needed for testing. 
  • Using a dedicated FNA needle pass, collect the FNA sample into the cytology tube.
  • Using a dedicated FNA, collect the FNA sample into the FNAProtect tube provided. 
  • Complete the requisition form on paper or online. 
  • Have the sample picked up with the courier service Veracyte partners with.

Online orders

You can order Afirma GSC alone or order cytopathology testing through our partners, Thyroid Cytopathology Partners with a reflex to Afirma GSC testing.

Visit our Afirma portal and login.

The amount of nodule material you need and the ordering process will depend on the option you choose.

Need help?

If you have questions about the ordering process, we’re here to help. Contact us today.

Medicare and insurance coverage for Afirma GSC

Afirma GSC is covered by Medicare. It is also in-network with most commercial payers. The Veracyte Access Program supports both eligible uninsured and commercially insured patients with financial needs.23

Medicare and Insurance Coverage Patient Financial Assistance

Frequently Asked Questions

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References

  1. Patel KN, et al. JAMA Surg. 2018. DOI: 10.1001/jamasurg.2018.1153
  2. Nasr CE, et al. J Clin Endocrinol Metab. 2022. DOI: 10.1210/clinem/dgac688
  3. Angell TE, et al. Thyroid. 2019. DOI: 10.1089/thy.2018.0726
  4. Hu MI, et al. J Clin Endocrinol Metab. 2021. DOI: 10.1210/clinem/dgab304
  5. American Cancer Society Facts & Figures, 2025.
  6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Thyroid Carcinoma V.1.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed [February and 18, 2026]. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  7. Giordano TJ, Beaudenon-Huibregtse S, Shinde R, et al. Molecular testing for oncogenic gene mutations in thyroid lesions: a case-control validation study in 413 postsurgical specimens. Hum Pathol 2014;45:1339-1347. Available at: https://www.ncbi.nlm.nih.gov/pubmed/24830619.
  8. Alexander EK, Kennedy GC, Baloch ZW, et al. Preoperative diagnosis of benign thyroid nodules with indeterminate cytology. N Engl J Med 2012;367:705-715. Available at: https://www.ncbi.nlm.nih.gov/pubmed/22731672.
  9. Nikiforov YE, Ohori NP, Hodak SP, et al. Impact of mutational testing on the diagnosis and management of patients with cytologically indeterminate thyroid nodules: a prospective analysis of 1056 FNA samples. J Clin Endocrinol Metab 2011;96:3390-3397. Available at: https://www.ncbi.nlm.nih.gov/pubmed/21880806.
  10. Ohori NP, Nikiforova MN, Schoedel KE, et al. Contribution of molecular testing to thyroid fine-needle aspiration cytology of “follicular lesion of undetermined significance/atypia of undetermined significance”. Cancer Cytopathol 2010;118:17-23. Available at: https://www.ncbi.nlm.nih.gov/pubmed/20099311.
  11. Rivera M, Ricarte-Filho J, Knauf J, et al. Molecular genotyping of papillary thyroid carcinoma follicular variant according to its histological subtypes (encapsulated vs infiltrative) reveals distinct BRAF and RAS mutation patterns. Mod Pathol 2010;23:1191-1200. Available at: https://www.ncbi.nlm.nih.gov/pubmed/20526288.
  12. Nikiforov YE, Steward DL, Robinson-Smith TM, et al. Molecular testing for mutations in improving the fine-needle aspiration diagnosis of thyroid nodules. J Clin Endocrinol Metab 2009;94:2092-2098. Available at: https://www.ncbi.nlm.nih.gov/pubmed/19318445.
  13. Musholt TJ, Fottner C, Weber MM, et al. Detection of papillary thyroid carcinoma by analysis of BRAF and RET/PTC1 mutations in fine-needle aspiration biopsies of thyroid nodules. World J Surg 2010;34:2595-2603. Available at: https://www.ncbi.nlm.nih.gov/pubmed/20652698.
  14. Lassalle S, Hofman V, Ilie M, et al. Clinical impact of the detection of BRAF mutations in thyroid pathology: potential usefulness as diagnostic, prognostic and theragnostic applications. Curr Med Chem 2010;17: 1839-1850. Available at: https://www.ncbi.nlm.nih.gov/pubmed/20345340.
  15. Chudova D, Wilde JI, Wang ET, et al. Molecular classification of thyroid nodules using high-dimensionality genomic data. J Clin Endocrinol Metab 2010;95:5296-5304. Available at: https://www.ncbi.nlm.nih.gov/pubmed/20826580.
  16. DiGennaro C, Vahdatzad V, Jalali MS, et al. Assessing bias and limitations of clinical validation studies of molecular diagnostic tests for indeterminate thyroid nodules: systematic review and meta-analysis.
    Thyroid 2022;32:1144-1157. Available at: https://www.ncbi.nlm.nih.gov/pubmed/35999710.
  17. Randolph GW, Sosa JA, Hao Y, et al. Preoperative identification of medullary thyroid carcinoma (MTC): clinical validation of the Afirma MTC RNA-sequencing classifier. Thyroid 2022;32:1069-1076. Available at: https://www.ncbi.nlm.nih.gov/pubmed/35793115.
  18. Kleiman DA, Sporn MJ, Beninato T, et al. Preoperative BRAF(V600E) mutation screening is unlikely to alter initial surgical treatment of patients with indeterminate thyroid nodules: a prospective case series of 960 patients. Cancer 2013;119:1495-1502. Available at: https://www.ncbi.nlm.nih.gov/pubmed/23280049.
  19. Mclver B, Castro MR, Morris JC, et al. An independent study of a gene expression classifier (Afirma) in the evaluation of cytologically indeterminate thyroid nodules. J Clin Endocrinol Metab 2014;99:4069-4077. Available at: https://www.ncbi.nlm.nih.gov/pubmed/24780044.
  20. Kloos RT, Reynolds JD, Walsh PS, et al. Does addition of BRAF V600E mutation testing modify sensitivity or specificity of the Afirma Ger Expression Classifier in cytologically indeterminate thyroid nodules? J C Endocrinol Metab 2013;98:E761-768. Available at: https://www.ncbi.nlm.nih.gov/pubmed/23476074.
  21. Theoharis C, Roman S, Sosa JA. The molecular diagnosis and management of thyroid neoplasms. Curr Opin Oncol 2012;24:35-41. Available at: https://www.ncbi.nlm.nih.gov/pubmed/22123232.
  22. Hodak SP, Rosenthal DS, Committee ATACA. Information for clinicians: commercially available molecular diagnosis testing in the evaluation of thyroid nodule fine-needle aspiration specimens. Thyroid 2013;23:131-134. Available at: https://www.ncbi.nlm.nih.gov/pubmed/22984796.
  23. Data on file.

Disclaimers

Afirma testing is available in the United States as part of Veracyte’s CLIA-validated laboratory developed test (LDT) service, and FDA clearance is not required.

Talk to your doctor about whether Veracyte tests might be right for you.

Veracyte Access eligibility is based on total annual household income, insurance status, and household size. Some eligibility restrictions apply. Veracyte Access offers the Afirma test at a reduced cost to eligible applicants except where otherwise restricted. Residents of the United States, District of Columbia and Puerto Rico are eligible to apply. Veracyte Access does not constitute health insurance. You must meet certain income requirements set forth above. We may request documentation to verify your income, including recently filed tax returns and other supporting documentation. By requesting assistance, you certify, to the best of your knowledge, that you are eligible for assistance and that you have insufficient financial resources to pay for the ordered test. We may discontinue or change this program at any time for any reason without notice.