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659 – Methods in Clinical Trials 2
Statistical Considerations in Detecting Circulating Tumor DNA Using Digital PCR
Shibing Deng
Pfizer Inc.
Maruja Lira
Pfizer Inc.
Circulating tumor DNA (ctDNA) provides a non-invasive and effective method for the detection, monitoring and treatment of cancer. It has been suggested to be a promising biomarker for patient disease prognosis and response to treatment. Recent developments in digital PCR (dPCR) make it a sensitive technology for ctDNA detection. Under assumption of Poisson distribution, the expected count of ctDNA in a patient blood sample was estimated from dPCR data. A limit of detection (LoD) for the assay was developed to allow an accurate detection of ctDNA in a sample. The proposed LoD was consistent with the data generated from several serial dilution experiments.