Combination Testing

ThyGeNEXT + ThyraMIR is the only testing platform that utilizes both mutational and microRNA markers to aid patient management

Why Combination Testing?

microRNA classification complements cytology and mutation analysis1

Variable PPV of RAS Mutations

microRNA classification further risk-stratified patients with weak driver mutations, including RAS12

“Mutations strongly associated with malignancy, such as BRAF V600E, RET fusions, and TERT, can assist in surgical decision-making. Other mutations considered weak drivers of cancer, such as RAS, carry less certainty.”12

ThyGeNEXT + ThyraMIR Testing Algorithm*1,12

Patient Management

*Testing algorithm based upon Bethesda Diagnostic Categories III (AUS/FLUS) and IV (FN/SFN).

ThyGeNEXT samples that are positive for BRAF, TERT, and RET/PTC will solely receive a ThyGeNEXT report. ThyGeNEXT samples that test positive for markers that have a lower risk of malignancy, such as RAS, will also receive a ThyraMIR report.

Patient management decisions are based on the independent medical judgment of the physician and molecular test results should be taken into consideration in conjunction with all relevant imaging, clinical findings, patient and family history, as well as patient preference.

NCCN guidelines for management of nodules with B3 and B4 cytology diagnoses include consideration of molecular analysis.15

Markers that MatterTM

Strategically Designed Mutation Panel for the Optimal Management of Thyroid Nodules

DNA mutation panelRNA panel (# fusions)
ALKALK (2)
BRAFBRAF (3)
GNASNTRK (8)
HRASPPARg (5)
KRASRET (14)
NRASTHADA (5)
PIK3CAmRNA markers:
NKX2-1, PAX8, TBP, USP33
PTEN
RET
TERT

microRNA classification complements cytology and mutation analysis1

FTCPTCPDTCATCMTC
UpregulatedmiR-222-3pmiR-222-3pmiR-222-3pmiR-222-3pmiR-375
miR-146b-5pmiR-146b-5pmiR-146b-5p miR-146b
miR-31-5p miR-551b
DownregulatedMiR-139-5pmiR-204-5pmiR-204-5pmiR-138-1-3p
miR-155-5p miR-29b-1-5p
miR-155-5p

Only Testing Platform with Both Mutational and microRNA markers

Patient management decisions are based on the independent medical judgment of the physician and molecular test results should be taken into consideration in conjunction with all relevant imaging, clinical findings, patient and family history, as well as patient preference.

References

1. Banizs AB, et al. Diagn Cytopathol. 2019;47(4):268-274. 2. Liu T, et al. Oncogene. 2014;33(42):4978-4984. 3. Landa I, et al. J Clin Endocrinol Metab. 2013;98(9):E1562-1566. 4. Nikiforov YE, et al. J Clin Endocrinol Metab. 2011;96(11):3390-3397. 5. Santoro M, et al. Cold Spring Harb Perspect Biol. 2013;5(12):a009233. 6. Liu X, et al. Endocr Relat Cancer. 2013;20(4):603-610. 7. Fussey JM, et al. Clin Endocrinol (Oxf). 2019;91(6):697-707. 8. Melo M, et al. J Clin Endocrinol Metab. 2014;99 (5):E754-765. 9. Censi S, et al. Eur J Endocrinol. 2019;181(1):1-11. 10. Marcadis AR, et al. Surgery. 2019;165(1):17-24. 11. Guan H, et al. Thyroid. 2020;30(4):536-547. 12. Lupo MA, et al. Diagn Cytopathol. 2020;1-11. https://doi.org/10.1002/dc.24564. 13. Liu R, et al. Endocr Relat Cancer. 2016;23(3):R143-R155. 14. Nabhan F, et al. Thyroid. 2018;28(6):729-738. 15. NCCN guidelines. Version 2.2020, Thyroid Carcinoma – nodule evaluation, THYR-3. 16. Bae JS, et al. Diagn Pathol. 2016;11:21. 17. Visone R, et al. Oncogene. 2007;26(54):7590-7595. 18. Nikiforova MN, et al. J Clin Endocrinol Metab. 2008;93(5):1600-1608.

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