Cytology

Afirma® Gene Expression Classifier is Now Available at Spectrum Health

Spectrum Health Hospital is pleased to offer patients access to Afirma® Gene Expression Classifier (GEC), a molecular test that helps diagnose thyroid nodules from the first fine needle aspiration (FNA) biopsy.

Patient’s with thyroid nodules often undergo unnecessary surgery, with 70-80% of indeterminate nodules being benign upon surgical histopathology.1-2 By using Afirma GEC in these cases, we can reclassify about 50% of indeterminate thyroid nodules as benign,3 which helps resolve diagnostic uncertainty and reduce unnecessary surgery. Additionally, when cytopathology is malignant or suspicious for malignancy, Afirma Malignancy Classifiers (Afirma MTC and Afirma BRAF) provide actionable insight to help inform the choice of surgery.

Afirma GEC is well validated, including a multi-center, prospective, blinded study published in the New England Journal of Medicine.3 The Afirma solution represents a new standard of care for thyroid nodule patients. Afirma GEC is consistent with molecular testing recommendations from the National Comprehensive Cancer Network, UpToDate and American Thyroid Association guidelines.

Afirma GEC integrates into our thyroid diagnosis process through the following steps:

  •  During the first FNA, perform two extra passes in order to collect and store a separate sample in the event Afirma GEC analysis is needed.
  •  Spectrum Health Regional Lab will perform standard cytopathology and provide a diagnosis.
  •  If the cytopathology diagnosis is indeterminate4 (Bethesda III or IV), Afirma GEC is performed to identify benign nodules. Afirma GEC is not performed when cytopathology is benign or malignant.
  •  If cytopathology identifies suspicious or malignant results, Afirma offers additional genomic tests-Afirma Malignancy Classifiers – to help guide surgical decisions.

All insurance plans are accepted for Afirma testing, including Medicare. A financial assistance program, Afirma Access, is available for patients who need support with out-of-pocket costs.

Please contact your local Afirma representative, Howie Niskar, (249-496-5626), Howie@veracyte.com for more details. To learn more, you can also visit www.Afirma.com/physicians.

1 Wang CC, et al. A large multicenter correlation study of thyroid nodule cytopathology and histopathology. Thyroid. 2011;21:243-251.
2 Lewis CM, et al. Thyroid fine-needle aspiration biopsy: variability in reporting. Thyroid 2009;19(7):717-723.
3 Alexander E, et al. Preoperative diagnosis of benign thyroid nodules with indeterminate cytology. N Engl J Med. 2012;367:705-715.

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