Importance of MRD Test
Minimal/molecular residual disease (MRD) testing to detect a cancer patient's circulating tumor DNA (ctDNA) has recently emerged as a powerful and often personalized addition to population-based disease biomarkers for the risk stratification, therapy decision support, therapeutic response monitoring and early assessment of disease recurrence. Numerous studies across different cancer types indicate that ctDNA-based MRD detection can provide and early indications of response to therapy and predict recurrence with high sensitivity and specificity, preceding standard imaging by months.1-5
RaDaR has been carefully designed to detect tumor DNA in the blood with exceptional sensitivity and specificity
- Increased accuracy with a tumor-informed, personalized panel design: RaDaR sequencing assays monitor up to 48 tumor-specific mutations, unique to each patient’s tumor, to help detect circulating tumor DNA (ctDNA)
- Earlier detection with high sensitivity: RaDaR can detect extremely low levels of ctDNA in the blood, with a demonstrated LoD95 = 0.001% VAF. This can give additional time for important treatment management decisions
- Fewer false positives with high specificity: RaDaR has a demonstrated analytical specificity of 100% in validation studies for more reliable results
LoD95 = limit of detection, working at a confidence of 95%; VAF = variant allele fraction.
Use cases for RaDaR in oncology clinical trials
(Neo)Adjuvant Setting
Stratify patients and enrich for ctDNA-positive patients
Therapeutic Monitoring
Follow response more deeply and support early therapy efficacy readouts
Surrogate Endpoints
Use ctDNA to support pathologic complete response (pCR) as potential surrogate endpoint
References: 1. Internal analytical validation 2. Cutts R, et al. AACR 2021 Abstract 536 3. Lipsyc-Sharf M, et al. J Clin Oncol. 2022;40:2408-2419 4. Gale D, et al. Ann Oncol. 2022;33(5):500-510. 5. Flach S, et al. Annals of Oncology (2022) 33 (suppl_7): S295-S322
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