Exceptional thyroid cancer diagnostics

The Afirma® Genomic Sequencing Classifier (GSC) is used in thyroid nodule assessment to help patients avoid unnecessary diagnostic surgeries and inform treatment decisions.

Afirma GSC website
  • Screening
  • Diagnosis
  • Prognosis/​treatment selection
  • Recurrence monitoring

Afirma

IMPROVING CARE FOR THYROID CANCER

The Afirma GSC clarifies diagnosis and informs treatment decisions

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The Afirma GSC helps physicians personalize thyroid cancer diagnosis and treatment decisions for their patients with thyroid nodules. The test was developed with RNA whole-transcriptome sequencing and advanced machine learning technology. This provides a comprehensive approach to evaluating thyroid nodules. The test helps rule out cancer in thyroid nodules when traditional test results are inconclusive. Historically, many such patients underwent surgery on nodules that ultimately proved to be benign, meaning the surgery was unnecessary.

For patients with suspected or diagnosed thyroid cancer, the Afirma GSC provides actionable information about their tumor’s genes to help physicians confidently guide treatment decisions.

A woman doing yoga.

WHEN THE TEST IS USED

Identify benign or suspicious thyroid nodules without surgery and gain insights for treatment

Veracyte’s Afirma GSC is performed on the same fine needle aspiration (FNA) sample that is used for initial cytopathology review. If that result is unclear, the Afirma GSC uses advanced genomic technology to identify the nodule as either benign or suspicious for cancer, without surgery. Patients with benign nodules are typically monitored, while those with suspicious nodules may be directed to surgery. Afirma GSC testing also provides important gene mutation information to guide treatment decisions for patients with nodules that are suspicious for cancer.

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BENIGN RESULTS

Avoid unnecessary surgery by identifying truly benign patients

SUSPICIOUS RESULTS

Inform surgery and treatment decisions

Clinical data for the Afirma GSC

The Afirma GSC is supported by dozens of published clinical studies, including those that followed patients for multiple years. Clinical validation data were published in JAMA Surgery demonstrating the test’s high sensitivity and negative predictive value.1 A published meta-analysis of 13 independent studies subsequently assessed the Afirma GSC’s performance in diverse clinical settings and demonstrated the test’s strong real-world performance.2 Results showed that the Afirma GSC had a sensitivity of 97% and a negative predictive value of 99%. The test’s Benign Call Rate of 65% means that it helped nearly two thirds of patients with benign thyroid nodules potentially avoid unnecessary diagnostic surgery.

97%

sensitivity2

99%

negative predictive value2

65%

positive predictive value2

FEATURED PUBLICATIONS

In JCEM: “Real-World Performance of the Afirma Genomic Sequencing Classifier (GSC)—A Meta-analysis”

JCEM article on Afirma GSC real-world performance

In JCEM: “Afirma Genomic Sequencing Classifier and Xpression Atlas Molecular Findings in Consecutive Bethesda III-VI Thyroid Nodules”

JCEM article on Afirma GSC findings in thyroid nodules
All clinical data

Serving patients across the US

The Afirma GSC is available to clinicians and their patients in the US and is performed in Veracyte’s CLIA-certified laboratory. The test is covered by Medicare and most private payers, making the test a covered benefit for approximately 275 million people. The test is also made available outside of the US on a case-by-case basis.

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Learn more about the Afirma GSC by meeting with us at upcoming events.

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A physician gently feels a patient’s neck to check the thyroid.
A woman looks up while a physician examines her throat.

Learn more about the Afirma GSC

Afirma GSC website

REFERENCES

  1. Patel KN, et al. JAMA Surg. 2018.

  2. Nasr C, et al. JCEM. 2022.

The Afirma Genomic Sequencing Classifier is available in the US as part of Veracyte’s CLIA-validated laboratory developed test (LDT) service. This test has not been cleared or approved by the FDA.

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