What is the Afirma test?
What is the Afirma test?
Afirma™ Gene Expression Classifier: a test for a group of molecular markers in thyroid biopsy specimens in order to determine the likelihood that a thyroid nodule is benign or cancerous. This test is performed by the company Veracyte Inc.
How accurate is Afirma test?
Afirma GEC test specificity is 52% (4), suggesting that just over half of the benign nodules are called GEC benign. Test PPV measures the fraction of “positive” calls by the test (e.g. Afirma GEC suspicious) that are correct. Afirma GEC test PPV is 37-38% amongst Bethesda III and IV nodules (4).
How much does Afirma testing cost?
The Afirma GEC measures the expression of 167 genes to more precisely determine the cancer risk of an indeterminate biopsied thyroid nodule and avoid unnecessary surgery. The test costs approximately $4,800 per nodule.
Is Afirma FDA approved?
The Afirma BRAF is designed to be used for nodules with “suspicious” results on Afirma GEC. In 2013, the U.S. Food and Drug Administration (FDA) approved through the premarket approval process the THxID™-BRAF kit, which is an in vitro diagnostic device to assess specific BRAF mutations in melanoma tissue via rtPCR.
What does a suspicious thyroid nodule mean?
For the U.S. population, the lifetime risk of developing thyroid cancer is 1.1 percent. When a thyroid nodule is suspicious – meaning that it has characteristics that suggest thyroid cancer – the next step is usually a fine needle aspiration biopsy (FNAB).
How can you tell if a thyroid nodule is cancerous?
If your doctor thinks a biopsy is needed, the simplest way to find out if a thyroid lump or nodule is cancerous is with a fine needle aspiration (FNA) of the thyroid nodule. This type of biopsy can sometimes be done in your doctor’s office or clinic.
How long does it take to get genetic test back?
How long does it take to get genetic test results? Commercial labs often give faster results (usually within 2 to 4 weeks) than research centers (a minimum of 4 weeks, often longer).
What does a suspicious thyroid biopsy mean?
“Suspicious” thyroid biopsy: this happens usually when the diagnosis is a follicular or hurtle cell caused lesion. Follicular and hurtle cells are normal cells found in the thyroid. Current analysis of thyroid biopsy results cannot differentiate between follicular or hurtle cell cancer from noncancerous adenomas.
Does Medicare cover Afirma testing?
Afirma has been covered by Medicare since 2012 and since 2018 has been priced at $3,600 on the CLFS based on private payor rates submitted under Section 1834A of the Social Security Act.
What is Afirma XA?
Afirma XA uses RNA sequencing of material collected via FNA to report expressed genomic variants and gene fusions that have been associated with thyroid cancer. These findings may refine the risk of cancer, especially among cytologically indeterminate nodules, depending on the specific alteration identified.
What is GEC test?
A gene expression classifier (GEC) test is a developing technology in the analysis of indeterminate thyroid nodules, using cells from a fine needle aspiration. The most common commercially available GEC in the United States is known as AFIRMA.
How is the afirma test used to diagnose thyroid?
The Afirma test is used for the preoperative classification of thyroid nodules with indeterminate cytology. This study reviews the authors’ institutional experience with Afirma. Methods: A cohort of 132 cases of thyroid FNA with Afirma testing was selected from the study files and relevant information was recorded and analyzed.
Where can I get the afirma blood test?
You will receive an email shortly with a list of practices in your area that offer the Afirma test. You will receive an email shortly with a list of practices in your area that offer the Afirma test.
What are the implications of a suspicious afirma test result?
Implications of a suspicious afirma test result in thyroid fine-needle aspiration cytology: an institutional experience Cancer Cytopathol. 2014 Oct;122(10):737-44.doi: 10.1002/cncy.21455. Epub 2014 Aug 13. Authors Ricardo R Lastra 1 , Michelle R Pramick, Cody J Crammer, Virginia A LiVolsi, Zubair W Baloch
What should I know about the afirma GEC test?
The patients were offered the Afirma™ GEC test if their cytology results returned in the indeterminate category. If the GEC returned benign, the patients were offered serial ultrasounds and clinical follow-up. If suspicious by GEC, thyroid surgery was recommended.
What is the Afirma test? Afirma™ Gene Expression Classifier: a test for a group of molecular markers in thyroid biopsy specimens in order to determine the likelihood that a thyroid nodule is benign or cancerous. This test is performed by the company Veracyte Inc. How accurate is Afirma test? Afirma GEC test specificity is 52%…