Joshua Klopper, MD
March 28, 2023
Veracyte strives to make the Afirma Genomic Sequencing Classifier (GSC) as simple, accessible, and comprehensive as possible for thyroid nodule assessment. Our mission is to provide physicians and their staff with relevant, clinically actionable data that they can use to make informed treatment decisions.
Until now, Afirma has been available as two tests: Afirma GSC and Afirma Xpression Atlas (XA). For nodules determined to be GSC Suspicious or with a cytopathology diagnosis of Bethesda V or VI, physicians ordered XA by checking a box. As of March 28, 2023, physicians who want variant/fusion information for these nodules only have to order Afirma GSC. If additional variant and fusion data are available, this data will automatically be provided in the patient report.
In addition, when ordering Afirma GSC, physicians now have the option to request a DNA analysis of the TERT promoter region. If ordered, the DNA analysis of TERT will be run and the results will be incorporated into the Afirma report if the nodule is GSC Suspicious or if the cytology diagnosis is Bethesda category V or Bethesda category VI.
Veracyte is committed to ensuring that Afirma GSC is accessible to physicians and their patients. Consolidating Afirma GSC and XA into one test creates a more accessible experience for physicians by removing complexity around the ordering process. One unified test also creates a streamlined billing experience for patients, and the Veracyte Access program ensures that cost is not a barrier for patients.
Will this change entail a big lift for my practice?
No – this improvement makes ordering Afirma simpler for your practice because clinical staff no longer have to determine when to order Xpression Atlas for variant and fusion information. The only change within your practice setting is to decide if you want to test for TERT, which is selected from the same test requisition form.
Will I still receive a binary result?
Yes – physicians will still receive a result that is either benign (with a 4% risk of malignancy similar to cytology benign3) or suspicious. In the past, the suspicious result only included variant or fusion information if Xpression Atlas was ordered. Now that information is provided automatically.
There have been several enhancements and updates to Afirma over the years, all geared towards the same goal: to provide the most up-to-date and clinically actionable result for your patient with a thyroid nodule. With this latest improvement to Afirma, Veracyte has merged these updates into one comprehensive test: Afirma GSC. The result is a simplified ordering process that makes it as easy as possible for the physician to order testing and understand the results.
To learn more about implementing Afirma, or to obtain a new test requisition form, get in touch with a Veracyte Product Specialist using the form below.