Natera announced analytical validation study results to be published online in the journal Transplantation demonstrating the superior performance of its donor-derived cell-free DNA test for detecting active rejection in kidney transplant recipients. The study showed superior assay precision with coefficient of variation up to five times better than previously published studies. Natera’s analytical validation was based on the analysis of 1,064 replicate samples from both related and non-related donor-recipient pairs. Conducted according to rigorous guidelines from the Clinical & Laboratory Standards Institute, the validation study measured key properties of the assay, including lower limit of detection, linearity, and precision. The assay’s precision was particularly strong, showing a coefficient of variation up to five times better than that of a competitive dd-cfDNA assay (1.85% vs. 9.2% within run; 1.99% vs. 4.5% across runs) in repeatability and reproducibility studies. Previously published analytical studies using other dd-cfDNA assays did not include related donor-recipient cases (such as parents or siblings), which is notable given the technical challenge of differentiating DNA patterns from close relatives. It has been estimated that 52% of live kidney donations originate from biologically related donors. Natera has leveraged its deep experience using single-nucleotide polymorphism -based methods to analyze fetal DNA in maternal blood to achieve high accuracy in these cases.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.