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, our genomic classifier has helped more than an estimated 40,000 patients avoid unnecessary thyroid surgery and has removed an estimated $800 million in surgery-related costs from the healthcare system. We believe that our combination of the Afirma Genomic Sequencing Classifier and the Afirma Xpression Atlas offers physicians the most comprehensive solution available for managing patients with thyroid nodules.

Afirma Genomic Sequencing Classifier
The next-generation Afirma Genomic Sequencing Classifier (GSC) resolves diagnostic uncertainty among the more than 525,000 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, but many of these nodules (70-80 percent), 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 GSC utilizes RNA sequencing and machine learning to identify benign thyroid nodules among those deemed indeterminate by cytopathology, so that patients can potentially avoid surgery and be monitored with CT imaging instead. The Afirma classifier is supported by more than 20 published scientific studies, including a prospective, multicenter clinical validation study published in The New England Journal of Medicine and three long-term clinical utility studies. A rigorous clinical validation study published in JAMA Surgery in 2018 demonstrates the next-generation Afirma GSC’s high sensitivity (91 percent) and specificity (68 percent), meaning that the test can potentially help nearly 70 percent of patients with indeterminate thyroid nodules avoid unnecessary surgery.

The Afirma classifier is recommended in leading practice guidelines and is covered by all major health plans in the United States, representing over 275 million members. Additionally, in tandem with the Afirma GSC, Veracyte’s Malignancy Classifiers provide information on medullary thyroid cancer and BRAF v600E mutation status, which may influence surgery decision-making for patients heading to surgery.

Afirma Xpression Atlas
The Afirma Xpression Atlas, introduced in May 2018, provides extensive genomic data that may further inform surgery strategy and treatment options for patients with thyroid nodules that are suspicious for cancer. The RNA sequencing-based test measures 761 DNA variants and 130 RNA fusions in over 500 genes that have been linked to thyroid cancer. In some cases, these gene alterations have demonstrated association with more aggressive thyroid cancers or with higher-stage disease.

The Afirma Xpression Atlas is offered as an extension to the Afirma GSC for patients with potentially cancerous thyroid nodules. As more becomes known about gene alterations and their impact on thyroid cancer development, prognosis and tumor pathway dependence, we believe this RNA sequencing information may help to guide patient care even further, including through the use of targeted therapies.

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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.