Afirma® Genomic Sequencing Classifier
Reducing Unnecessary Surgeries and Informing Treatment Decisions in Thyroid Cancer Diagnosis
The Afirma Genomic Sequencing Classifier (GSC) provides physicians with a comprehensive solution for a complex landscape in thyroid cancer diagnosis and individualization of care. Our offering enables physicians to answer multiple clinical questions for their thyroid patients using a single, minimally invasive fine needle aspiration (FNA) sample.
The Afirma GSC resolves diagnostic uncertainty among the approximately 565,000 patients who undergo FNA biopsies each year to assess potentially cancerous thyroid nodules. Up to 30 percent of these patients may 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 dozens of published scientific studies, including multiple long-term clinical utility studies. Clinical validation data published in JAMA Surgery 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 diagnostic 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).
The Afirma GSC resolves diagnostic uncertainty among the approximately 565,000 patients who undergo FNA biopsies each year to assess potentially cancerous thyroid nodules. Up to 30 percent of these patients may 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 dozens of published scientific studies, including multiple long-term clinical utility studies. Clinical validation data published in JAMA Surgery 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 diagnostic 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 included in leading practice guidelines and is covered by Medicare and most major commercial health plans in the United States. Our Afirma offering includes the Xpression Atlas (XA), which provides physicians with comprehensive genomic alteration information from the same FNA sample used in Afirma GSC testing. Afirma XA results may enable physicians to confidently tailor surgery strategy or treatment options for patients whose thyroid nodules are cancerous or suspicious for cancer.
Access Afirma MSDS Documentation
Access Afirma MSDS Documentation
