Afirma® Genomic Sequencing Classifier
Reducing Unnecessary Surgeries and Informing Treatment Decisions in Thyroid Cancer Diagnosis

The Afirma Genomic Sequencing Classifier (GSC) and Xpression Atlas (XA) provide physicians with a comprehensive solution for a complex landscape in thyroid cancer diagnosis and individualization of care. The combined offering enables physicians to answer multiple clinical questions for their thyroid patients using a single, minimally invasive fine needle aspiration (FNA) sample.

Afirma Genomic Sequencing Classifier
The next-generation Afirma GSC resolves diagnostic uncertainty among the approximately 525,000 patients who undergo FNA biopsies each year to assess potentially cancerous thyroid nodules. Up to 30 percent of these patients receive indeterminate results – meaning they are not clearly benign or malignant – and, historically, most were directed to diagnostic surgery even though 70 percent to 80 percent of the time the nodules ultimately proved to be benign.

The Afirma GSC was developed with RNA whole-transcriptome sequencing and machine learning to identify benign thyroid nodules among those deemed indeterminate by cytopathology so that these patients may avoid unnecessary surgery. Afirma testing is supported by nearly 30 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. Clinical validation data published in JAMA Surgery in 2018 demonstrate 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 whose thyroid nodules are actually benign, but who had indeterminate cytopathology results, avoid unnecessary surgery. Additionally, the Afirma GSC is proven to detect medullary thyroid cancer – a rare, but aggressive, form of the disease – with high accuracy (100 percent sensitivity and specificity).

Afirma testing is recommended in leading practice guidelines and is covered by Medicare and all of the major commercial health plans in the United States.

Afirma Xpression Atlas
The Afirma XA provides physicians with genomic alteration information from the same FNA samples that are used in Afirma GSC testing. The test may enable physicians to confidently tailor surgery strategy or treatment options for patients whose thyroid nodules are cancerous or 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.

As more becomes known about gene alterations and their impact on thyroid cancer development, prognosis and tumor pathway dependence, Veracyte believes this RNA sequencing information may help to guide patient care even further, including through the use of targeted therapies that are available or in development.

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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.