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Signatera™ for Renal Cell Carcinoma (RCC)

 

Signatera™ is a personalized, tumor-informed ctDNA assay designed to detect molecular residual disease (MRD), refine post-nephrectomy risk stratification, and inform treatment decisions in patients with RCC.

Detect molecular recurrence in RCC

Up to ~40% of patients with RCC may experience recurrence following surgery.³ Conventional imaging and pathology may miss residual molecular disease.¹

Signatera™ is a personalized, tumor-informed ctDNA assay designed to detect molecular recurrence and support treatment decision-making in RCC.¹

Personalized ctDNA monitoring in RCC

Test

ctDNA-positive patients

9x

more likely to recur vs, ctDNA-negative patients.1

Know

ctDNA-negative patients

93%

negative predictive value for recurrence-free survival.2

Decide

Longitudinal MRD testing

100%

sensitivity and specificity for recurrence detection.1

Clinical evidence supporting Signatera™ in RCC

Signatera™ has demonstrated prognostic utility in localized and metastatic RCC for recurrence detection, risk stratification, and treatment-response monitoring.¹˒²

Localized RCC recurrence detection

  • ctDNA-positive patients had significantly shorter recurrence-free survival vs ctDNA-negative patients¹
  • Longitudinal ctDNA monitoring identified recurrence with 100% sensitivity and specificity among relapsed patients¹

Metastatic RCC treatment-response monitoring

  • ctDNA positivity was associated with shorter progression-free survival during surveillance¹
  • Serial ctDNA monitoring provided insight into disease progression and treatment response¹

Post-nephrectomy risk stratification

  • ctDNA status post-nephrectomy was prognostic for disease-free survival²
  • ctDNA-negative patients demonstrated a 93% negative predictive value for recurrence-free survival²

FAQs

What does a ctDNA-negative result mean after nephrectomy?

In MRD-GATE RCC, ctDNA-negative patients managed with observation had a 93% likelihood of remaining disease-free during follow-up.²

Can Signatera™ detect recurrence earlier than imaging?

Yes. In localized RCC, all recurrences were detected at or before clinical recurrence using longitudinal Signatera™ testing.¹

Is Signatera™ right for your patients?

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References

1Suri Y, Sudhaman S, Dwivedi B, et al. Clinical Performance of a Tumor-Informed Whole Genome-Based (WGS) ctDNA Assay for Recurrence Detection and Treatment Response Monitoring in Localized and Advanced/Metastatic Renal Cell Carcinoma (RCC). Presented at: ESMO Congress 2025; October 17–21, 2025; Berlin, Germany.

2Basu A, Sidhom F, Hwang C, et al. Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC) — MRD-GATE RCC. Journal of the National Comprehensive Cancer Network. 2025;23(3.5):YIA25-001. doi:10.6004/jnccn.2024.7289.

3Ljungberg B, Albiges L, Abu-Ghanem Y, et al. European Association of Urology Guidelines on Renal Cell Carcinoma: 2022 Update. European Urology. 2022;82(4):399-410.

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