WHY AFIRMA

Complex Landscape:

Thyroid nodule diagnosis is challenging

Arriving at an accurate diagnosis and treatment plan requires comprehensive information

ATA guidelines recommend more individualized care, as “…risk stratification is the cornerstone of individualized thyroid cancer management.”²

Afirma enables individualized care and is supported by both ATA and NCCN guidelines

The Afirma Platform:

A unified and simple solution for all of your patients

Gain accurate and clinically actionable results from the first FNA

Afirma has helped over 150,000 patients conclusively rule out surgery or confidently tailor treatment^4,6

Low risk

Afirma Genomic Sequencing Classifier:

Conclusively rule out surgery¹

Clinically validated through a study published in JAMA Surgery with a blinded, multicenter, prospectively collected cohort¹

The only thyroid nodule molecular diagnostic test with reproducible results in independent, real-world studies published in peer-reviewed journals^7-12

Dependable Hürthle cell performance proven through real-world experience

Hürthle cells are dominant in >20% of indeterminate nodules and have been challenging to classify as high or low risk^7,8,11

*Confirmed through histopathologic data from surgically resected nodules
NIFTP = noninvasive follicular thyroid neoplasm with papillary-like nuclear features

high risk

Afirma Xpression Atlas:

Confidently tailor treatment⁵

Informs selection of surgical and therapeutic decisions⁵

Clinically validated⁵ and informed by:

The Cancer Genome Atlas (TCGA)¹⁴
Extensive published literature⁶
Veracyte R&D discovery using nearly 40,000 samples⁶

The largest thyroid gene and fusion panel available⁶

Including >100 novel, Veracyte R&D-discovered fusions (of ALK, BRAF, NTRK, RET) that all have importance in patient management^6,15

Includes the most clinically relevant and emerging variants and fusions associated with thyroid carcinoma, such as:

Detects variants and fusions that may inform targeted therapy, such as:

Afirma XA is reported for Afirma GSC suspicious and Bethesda V and VI nodules

Afirma Patient Report:

Relevant and actionable results

Provides variant/fusion-specific risk of malignancy (ROM) using clinically relevant evidence

The Afirma XA result may further refine the Afirma GSC suspicious result of ~50% ROM^5,6,16

Predicts tumor behavior and informs surgical approach by expression signature^14,17

Offers additional insight for treatment decisions with:

Potential FDA-approved alteration-specific therapies for advanced or recurrent patients
Genetic counseling/germline testing considerations
Results interpretation that summarizes key considerations (e.g., "clinical correlation and clinical resection should be considered")

Afirma GSC and Xpression Atlas:

Count on a simplified experience for your patients and your practice

Veracyte is committed to providing patient access, regardless of financial situation

- Covered by Medicare with no copayment⁶
- Covered in-network by most commercial payers (over 275 million covered lives)⁶
- The Veracyte Access Program supports both uninsured and commercially insured patients with financial need⁶

Get answers quickly, reduce worry and wait⁶

- All-inclusive collection kit
- Afirma GSC and XA on the same test requisition form

Easily manage patient reports with the Veracyte portal and mobile app

- Access the Veracyte portal at: portal.veracyte.com
- Download the Veracyte app from your mobile app store

References: 1. Patel KN, et al. JAMA Surg. 2018. 2. Haugen BR, et al. Thyroid 2016. 3. Bongiovanni M, et al. Acta Cytol. 2012. 4. Ali SZ, et al. Cancer Cytopathol. 2019. 5. Angell TE, et al. Front. Endocrinol. 2019. 6. Data on File. 7. Angell TE, et al. Thyroid 2019. 8. San Martin VT, et al. JCEM 2019. 9. Andrioli M, et al. Endocr. Pathol. 2020. 10. Wei S, et al. Cancer Cytopathol. 2019. 11. Harrell RM, et al. Endocr. Pract. 2018. 12. Endo M, et al. Thyroid 2019. 13. Hao Y, et al. BMC Syst. Biol. 2019. 14. TCGA Research Network. Cell 2014. 15. Wirth LJ, et al. ENDO 2020. 16. Goldner WS, et al. Thyroid 2019. 17. Yoo SK, et al. PLOS Genet. 2016.