Afirma® Thyroid FNA Analysis
Reducing Unnecessary Surgeries in Thyroid Cancer Diagnosis

The Afirma Thyroid FNA Analysis is transforming thyroid cancer diagnosis. Since its commercial launch in 2011, it has helped tens of thousands of patients avoid unnecessary thyroid surgery and has removed an estimated $500 million in surgery-related costs from the healthcare system, with a projected cost reduction of one billion dollars over the next five years. Our offering is based on our proprietary Afirma Gene Expression Classifier, which resolves diagnostic uncertainty among the more than 500,000 patients who undergo fine needle aspiration (FNA) biopsies each year to assess potentially cancerous thyroid nodules. Up to a third of these FNAs produce inconclusive results. Historically, most of these patients were directed to surgery to remove all or part of their thyroid for a more definitive diagnosis. Many of these nodules (70-80 percent), however, proved to be benign, meaning the surgery was unnecessary. Thyroid surgeries are invasive, potentially risky, and expensive, and often result in patients requiring lifelong daily thyroid-hormone therapy.

The Afirma GEC identifies benign thyroid nodules, among those initially deemed inconclusive by cytopathology, so that these patients can potentially avoid surgery and be monitored with CT imaging instead. The Afirma GEC is supported by more than 20 published scientific studies, including a prospective, multicenter clinical validation study published in The New England Journal of Medicine, which suggested that the test can reduce the number of unnecessary surgeries by 50 percent. The Afirma GEC is recommended in leading practice guidelines and is covered for 185 million lives in the United States, including through Medicare and most commercial insurance plans.

The company’s Afirma Malignancy Classifiers—comprising tests for medullary thyroid cancer and BRAF gene mutation status—are designed to inform surgical strategy for those patients headed to surgery based on their cytopathology or Afirma GEC results.
 


Learn More About the Afirma Thyroid FNA Analysis

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A Patient’s Perspective
“The Afirma test saved me from a big change in my life...”

– VIRGINIA BARNES, Afirma Patient
Why Physicians Use Afirma
“...I have cut down the potential risks the patient would be exposed to from the surgery and I have a happy patient at the end of all this, which is key to me.”

– KISHORE LAKSHMAN, M.D.