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
ctDNA-positive patients
9x
more likely to recur vs, ctDNA-negative patients.1
ctDNA-negative patients
93%
negative predictive value for recurrence-free survival.2
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?
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.