Afirma Thyroid FNA Analysis
The Evolved Solution for Improved Thyroid Nodule Assessment
An Unmet Clinical Need is Addressed
Ambiguous results on thyroid fine needle aspiration (FNA) samples have been a common and significant problem for physicians and their patients. FNA samples can be challenging to interpret and produce indeterminate results in up to 30 percent of cases.1
Current guidelines recommend that most of these patients undergo a diagnostic thyroid surgery to assess whether the nodules are benign or malignant.1,2 In approximately 70 percent of the time, the nodules are diagnosed as benign by
surgical pathology.3,4
The novel Gene Expression Classifier (GEC), the centerpiece of the Afirma Thyroid FNA Analysis, promises to help physicians reduce the number of avoidable surgeries by preoperatively reclassifying indeterminate nodules as benign. The GEC measures the gene expression of 142 genes* and applies a multi-dimensional algorithm to classify whether a nodule with cytopathology indeterminate diagnosis is benign or suspicious.5 The final gene set resulted from a whole genome approach that assessed the 22,000 genes (247,000 transcripts) in the human genome.6
The GEC is Available as Part of the Afirma Thyroid FNA Analysis
The Afirma Thyroid FNA Analysis combines specialized cytopathology and the novel Afirma GEC. Physicians submit to Veracyte thyroid nodule FNA samples collected in a single patient visit. Then, a thyroid cytopathology specialist at Thyroid Cytopathology Partners (TCP), an independent partner of Veracyte, performs cytopathology assessment of a thyroid nodule FNA sample under the microscope. If the cytopathology diagnosis is benign or malignant, the analysis is complete. Only when TCP's cytopathology diagnosis is indeterminate* (a recent study showed TCP’s indeterminate rate to be 16%)7 is the proprietary Gene Expression Classifier performed.
The TCP team reads thousands of cases each month, making them the largest thyroid-only cytopathology group.8 Their volume and specialization expose them to rare neoplasms, including medullary thyroid cancer, on a routine basis.9 In addition, they have implemented processes such as routine over-reads to ensure quality and consistency is maintained.8 Learn more about TCP at thyroidcytopath.com.
Clinical Validity, Utility and Cost Effectiveness of the Afirma Gene Expression Classifier
A recent large, multi-center (49 sites), prospective clinical validation study recently published online in the New England Journal of Medicine (NEJM) demonstrated that thyroid nodules with cytopathology indeterminate** and a Benign GEC result have less than 6% likelihood of being malignant (greater than 94% Negative Predictive Value).5 These results, consistent with earlier findings,9 show the risk of malignancy of a GEC Benign result is comparable to that of nodule diagnosed as benign by cytopathology.3,4 As a result, the authors of the NEJM study and associated editorial suggest that physicians can consider watchful waiting in lieu of surgery in patients with cytopathology indeterminate and GEC benign results.5,10
Additional clinical utility studies have shown that physicians are routinely choosing to follow their patients with GEC Benign results.6,11 Marrying these results with cost-effectiveness modeling conducted by researchers at the Johns Hopkins School of Public Health and School of Medicine (Endocrinology) indicate that incorporating the Afirma GEC into routine practice can improve quality of life and remove cost from the healthcare system.7,11,12
A Comprehensive Patient-centric Approach to Thyroid Nodule Management
By combining specialized cytopathology and the Gene Expression Classifier, the Afirma Thyroid FNA Analysis:
- Enables physicians to identify patients who may avoid surgery5,7,10,11
- Empowers confident and timely clinical decisions from a single patient visit8
- Gives patients access to specialized cytopathology and robust science5,7-9,11
- Ensures quality and convenience in collecting and shipping patient samples8,13
- Allows patients to receive better care at a lower cost5,10,12
* The Gene Expression Classifier also assesses the expression levels of 25 supplemental genes to improve classification of rare cancer subtypes.
** Indeterminate includes Follicular Lesion of Undetermined Significance (FLUS)/Atypia of Undetermined Significance (AUS) and (suspicious for) Hürthle/Follicular Neoplasm.
1. Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, et al. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. .2009;19:1167-1214.
2. Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedüs L, et al. American Association of Clinical Endocrinologists, Associazione Medicie Endocrinologi, and European Thyroid Association medical guidelines for clinical practice for the diagnosis and management of thyroid nodules: executive summary of recommendations. Endocr Pract. 2010;16(S1):1-43.
3. Wang CC, Friedman L, Kennedy GC, Wang H, Kebebew E, Steward DL, et al. A Large Multicenter Correlation Study of Thyroid Nodule Cytopathology and Histopathology. Thyroid. 2011;21:243-251.
4. Lewis CM et al. Thyroid Fine-Needle Aspiration Biopsy: Variability in Reporting 2009 Thyroid 19(7) 717-722.
5. Alexander EK, et al. Preoperative Diagnosis of Benign Thyroid Nodules with Indeterminate Cytology. N Engl J Med. 2012;367:705-715.
6. Chudova D, Wilde JI, Wang ET, Wang H, Rabbee N, Egidio CM, et al. Molecular Classification of Thyroid Nodules Using High-Dimensionality Genomic Data. J Clin Endocrinol Metab. 2010;95:5296-5304.
7. Monroe R, Zalles C, Traweek T, et al. Clinical Practice Impact of a Novel mRNA–based Gene Expression Classifier in Thyroid Nodules with Indeterminate Fine Needle Aspiration Cytopathology. [Abstract 1161809] Program of the 81st Annual Meeting of American Thyroid Association, Indian Wells, CA, 2011.
8. Data on File. Veracyte, Inc.
9. Kloos KT, O’Reilly K, Traweek ST, et al. Novel Gene Expression Classifier Raises Pre-operative Suspicion of Thyroid Cancer. [Poster 1332] 21st Annual Meeting and Clinical Congress of American Association of Clinical Endocrinology, Philadelphia, PA. May 23-27, 2012.
10. Jameson JL, Minimizing Unnecessary Surgery for Thyroid Nodules, N Engl J Med. 2012;367:765-767
11. Duick DS, Klopper JP, Diggans JC,Friedman L, Kennedy GC, Lanman RB, et al. The impact of benign gene expression classifier test results on the endocrinology decision-to-operate in patients with thyroid nodules with indeterminate FNA cytopathology. [Poster 1108] 21st Annual Meeting and Clinical Congress of American Association of Clinical Endocrinology, Philadelphia, PA. May 23-27, 2012.
12. Li H, Robinson KA, Anton B, Saldanha IJ, Ladenson PW. Cost-Effectiveness of a Novel Molecular Test for Cytologically Indeterminate Thyroid Nodules. J Clin Endocrinol Metab. 2011;96:E1719-E1726.
13. Walsh S, Wilde JI, Tom E, et al. Analytical Verification of a Novel Gene Expression Test which Identifies Benign Thyroid Nodules in Patients with Indeterminate Fine Needle-Aspiration (FNA) Cytology. [Abstract 1098] 2011 Late Breaking Abstracts of the 20th Annual Meeting and Clinical Congress of American Association of Clinical Endocrinology, San Diego, CA, April 2011, p 2–3.
Afirma Thyroid FNA Analysis Description
The Afirma Thyroid FNA Analysis is a diagnostic service provided by Veracyte, Inc. for the assessment of thyroid nodules. Patient samples obtained through fine needle aspirate (FNA) biopsies are collected for both cytopathology assessment and the Gene Expression Classifier. Initially, cytopathology assessment is conducted. If the cytopathology diagnosis is benign, suspicious for malignancy, malignant or nondiagnostic, the Afirma Thyroid FNA Analysis is complete. If the cytopathology diagnosis is indeterminate (includes Follicular Lesion of Undetermined Significance (FLUS)/Atypia of Undetermined Significance (AUS) and (suspicious for) Hürthle/Follicular Neoplasm), the thyroid nodule is greater than or equal to 1 cm and the patient is 21 years or older, the Gene Expression Classifier is performed. The Gene Expression Classifier determines the expression profile of RNA isolated from the nodule to be benign or suspicious for malignancy. Clinical correlation of the Afirma Thyroid FNA Analysis result is recommended. The Afirma Gene Expression Classifier and its performance characteristics were determined by Veracyte. Afirma Thyroid FNA Analysis is used for clinical purposes.
The Veracyte laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. The Veracyte laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing.
Veracyte Laboratory Licenses: CLIA: 05D2014120 California: CLF340176
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