Afirma Thyroid Analysis May Help Patients Avoid Surgery

Nodules No Longer Classifed as Inconclusive or Indeterminate

thyroid cancer, afirma test, veracyte
Universal Images Group / Getty

Thyroid cancer is the fastest-growing cancer in the United States. There are an estimated  56,870 new cases in 2017, according to the American Cancer Society. Along with the increased awareness of thyroid cancer comes increased  scrutiny of thyroid nodules. Thanks to more vigilant monitoring, ultrasounds, and x-rays, more thyroid nodules are being detected and evaluated.

When your thyroid nodule is considered suspicious—meaning that it has characteristics that may suggest thyroid cancer—the key evaluation is a fine needle aspiration (FNA) biopsy.

The FNA biopsy helps determine whether your nodule is malignant (thyroid cancer) or benign.

One of the most frustrating challenges facing endocrinologists and thyroid patients is when an FNA on a suspicious nodule is found to be "inconclusive" or "indeterminate." In this case, the pathology assessment cannot rule out cancer, and the recommended follow-up is thyroidectomy, a surgery to remove the thyroid. The thyroid gland is then thoroughly evaluated by a pathologist to conclusively diagnose or rule out thyroid cancer.

When thyroid cancer is found, the thyroidectomy is considered a necessary and appropriate step in treatment.

But when no thyroid cancer is discovered, the patient has needlessly lost a vital organ, and in the process, become hypothyroid for life. The health impact of an unnecessary thyroidectomy can be life-changing -- those patients become hypothyroid and face a lifetime of tests, prescription drug treatment, and monitoring, as well as the symptoms and conditions associated with hypothyroidism.

In addition to the health impact, these needless thyroid surgeries are costly, and a drain on the healthcare system. The cost of thyroid surgery typically runs $15,000 to $20,000, and when the gland is needlessly removed, there are additional lifelong costs for blood tests, hypothyroidism medications, and physician monitoring.

How Many People Are Affected?

Let's look at the extent of the problem. First, it's estimated that approximately 450,000 suspicious thyroid nodules undergo FNA annually in the United States. Up to 30 percent of the nodules assessed by FNA are indeterminate/inconclusive, meaning that thyroidectomy is recommended to as many as 135,000 patients due to an inconclusive FNA.

The crucial issue is that only 20 to 30 percent of inconclusive nodules turn out to be malignant. That means that as many as 100,000 patients in the U.S. each year could end up undergoing a needless thyroidectomy, due to inconclusive nodules that turn out to be benign.

A test, called the Afirma Thyroid FNA Analysis, can help avoid the negative health effects and costs of these needless thyroidectomies. The test, developed by a company called Veracyte, helps patients and physicians avoid inconclusive results on thyroid nodules through a two-step process. The first step is cytopathology—pathology assessment at the cellular level—by Thyroid Cytopathology Partners (TCP), an independent laboratory partner of Veracyte. Indeterminate samples go through step two, their proprietary Gene Expression Classifier, which then classifies indeterminate nodules as either benign or suspicious.

According to Bonnie Anderson, Veracyte co-founder and Chief Executive Officer, "The goal of the Afirma Thyroid FNA Analysis is to give doctors better information that can help patients with thyroid nodules avoid inconclusive FNA results, and the potential diagnostic odyssey and unnecessary surgery that can follow such results. We believe this will not only improve patient care but will also provide cost savings to the healthcare system."

The Afirma Thyroid FNA Analysis Process

The Afirma process can be used to evaluate adult patients (21 or older) with nodules greater than or equal to 1 cm in size.

Before an FNA is scheduled or performed, a patient who wants to use the Afirma process needs to identify a treating physician who is already familiar with the test's collection procedures and has the proper supplies on hand to collect and ship the sample. 

The treating physician performs a single FNA, which usually involves 4 to 5 samples, also known as "passes." The FNA sample is then split, with two passes collected for initial cytopathology and two passes collected in the event the first assessment is inconclusive. The physicians use standard thyroid FNA technique—no special training is necessary—but do collect the samples using sample collection and transport supplies provided by Veracyte.

The treating physician sends the patient samples overnight to TCP, and the samples are then evaluated. They make a cytopathology diagnosis, and if the nodule is clearly benign or malignant, the Afirma Thyroid FNA Analysis is complete. A patient report is prepared and sent to the treating physician, usually within five days.

If the cytopathology is indeterminate, then the samples go on to a second step called the Gene Expression Classifier. This is a genomic test that measures gene expression patterns of the sample to make a diagnosis of either "benign" or "suspicious for malignancy." If the initial cytopathology results are indeterminate, and the Afirma Gene Expression Classifier is used, the report usually is sent within 14 days.

Richard Lanman, MD, Veracyte's Chief Medical Officer, explains what it means to measure gene expression patterns:

"This refers to the ability to determine if particular genes in a cell are expressed, or 'turned on,' and how they are expressed in relation to each other as an indicator of the nodule's behavior -– for example, whether the nodule is benign or potentially cancerous. To develop the Afirma Gene Expression Classifier, Veracyte evaluated hundreds of thyroid samples to identify 142 different genes that best distinguish benignity from malignancy. The test is then based upon powerful algorithms and sophisticated statistical approaches that determine if and to what degree these genes are activated in a given thyroid FNA sample."

If after either step, the analysis shows the nodule to be benign, then periodic follow-up and monitoring of the nodule, as is recommended for any benign nodules, is typically recommended.

Overall, a series of studies evaluating the Afirma Thyroid FNA Analysis has shown that in more than 95 percent of the cases, when the test indicated that cancer was not present, there was, in fact, no cancer present.

Data from researchers at Johns Hopkins University School of Medicine also suggest that routine use of the Afirma process nationally would reduce the number of surgeries performed on patients with benign thyroid nodules by 74 percent, or 50,000 surgeries each year, and would generate in excess of $600 million in direct medical savings over a five-year period.

In addition to reducing the number of surgeries on patients who have benign nodules, research reported on in the Journal of Clinical Endocrinology and Metabolism also found that routine use of the Afirma process could increase by more than 50 percent the likelihood that patients who have surgery actually do have thyroid cancer.

A Word from Verywell 

Because the Afirma Thyroid FNA Analysis is still relatively new,  some endocrinologists and physicians are not offering it at present. So if you are going to undergo an FNA biopsy and want the Afirma Thyroid FNA Analysis used, you need to have the FNA performed by a physician who is already using the test. Patients can call Veracyte for information on physicians who offer the service.

You can also speak with your physician about offering the Afirma process. According to Veracyte, physicians and their staff can be trained in one day to adopt the Afirma process.

If you have already had an FNA biopsy that found an indeterminate nodule, and your physician is recommending thyroidectomy, you may be interested in having another FNA done with a physician who uses the Afirma process. Having a conclusive result could potentially prevent an unnecessary surgery.

The Afirma Thyroid FNA Analysis test process is priced at around $3,500.

Veracyte accepts all insurance to pay for the test, and they will manage the claims process for patients. To date, several insurance companies are already reimbursing for the test. Veracyte has also set up a program called "Afirma Access," which helps patients manage out-of-pocket expense in cases where the insurance carrier may not agree to coverage.

For more information, see the Veracyte website for Afirma at http://www.veracyte.com/afirma.

Sources:

July 25, 2011 telephone and email interview with Bonnie Anderson, Chief Executive Officer of Veracyte, and Richard Lanman, MD, Chief Medical Officer.

American Cancer Society. "Cancer Facts & Figures 2017." Atlanta: American Cancer Society; 2017.

Baloch ZW et al. "Diagnostic terminology and morphologic criteria for cytologic diagnosis of thyroid lesions: a synopsis of National Cancer Institute Thyroid Fine-Needle Aspiration State of the Science Conference. " Diagn Cytopathol. 2008;36:425

Gharib H, et al. "American Association of Clinical Endocrinologists, Associazione Medici Endocrinologi, and European Thyroid Association medical guidelines for clinical practice for the diagnosis and management of thyroid nodules. " Endocr Pract. 2010;16 Suppl 1

Ladenson PW, et al. "Poster presented at ENDO 2010: The 92nd Annual Meeting & Expo." San Diego; 2010.

Veracyte.com. "The Clinical Need for Improved Thyroid Nodule Assessment,Clinical Need Overview , Online PDF

 

Continue Reading