Personalis, Inc. announced a new publication validating the company?s NeXT Personal test, an ultra-sensitive, tumor-informed circulating tumor DNA (ctDNA) assay. NeXT Personal is designed to help detect minimal residual disease (MRD), monitor therapy response, and identify recurrence with high analytical sensitivity and accuracy, enhancing the decision-making process and ultimately improving patient outcomes in the ongoing battle against cancer. In the analytical validation study published in Oncotarget, scientists from Personalis evaluated NeXT Personal by testing samples from over 120 patients across nine cancer types and paired tumor and normal cell lines.

The NeXT Personal technology leverages whole genome sequencing (WGS) and advanced noise suppression with NeXT SENSE technology to identify a unique genetic signature derived from a patient?s tumor based on up to approximately 1,800 variants. Through NeXT Personal, a custom panel is created to detect trace amounts of ctDNA from patient blood samples. The analytical range measurements demonstrated a detection threshold of 1.67 parts per million (PPM) of ctDNA with a LOD95 of 3.45 PPM, highlighting NeXT Personal?s ultra-high analytical sensitivity.

Results of the study showed 100% measured analytical specificity, with a confidence interval spanning 99.92 to 100%.