Natera begins study on benefits of Signatera’s method for ctDNA quantification

Natera announced a new study published in Molecular Oncology comparing the performance of mean tumor molecules per milliliter, MTM/mL, against mean variant allele frequencyor mVAF for measuring circulating tumor DNA or ctDNA, using Signatera Natera’s personalized and tumor-informed molecular residual disease, MRD, test. The full study can be found here. To date, mVAF and MTM/mL are the two main metrics that have been used to quantify ctDNA levels in the blood. Unlike mVAF, which is a fraction that can be confounded by changes in total background cfDNA, MTM/mL takes into account total cfDNA as well as plasma volume. The premise is that MTM/mL is therefore more representative of a patient’s true disease burden, a hypothesis that was validated in this study. The study analyzed ctDNA data generated in 55,183 ctDNA-positive samples from 23,543 patients who underwent testing with Signatera for various cancer diagnoses, and it reported the correlation between MTM/mL and mVAF, as well as the correlations of each with patient outcomes…”We are pleased to see the publication of these important findings, in which MTM/mL provided a more accurate measure of ctDNA than mVAF, particularly for patients undergoing active therapy which can impact the levels of background cfDNA,” said Minetta Liu, M.D., chief medical officer of oncology at Natera. “Clinicians need tools to enable reliable predictions of therapy response and clinical outcomes. As the only MRD test that uses MTM/mL, this study supports the utility of Signatera for ctDNA quantification, to measure treatment response at critical time points and inform decisions on how patients are managed.”