MENLO PARK, Calif.–Dec. 16, 2021–Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced the launch of NeXT Personal, a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify molecular residual disease (MRD) and recurrence in patients previously diagnosed with cancer. NeXT Personal delivers industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. This enables earlier detection across a broader variety of cancers and stages, including typically challenging early stage, low mutational burden, and low-shedding cancers.
NeXT Personal leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially-selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. The targeted panel is then used to sequence millions of unique DNA molecules from a patient’s blood sample. Aggregation of signal across these sequences using proprietary algorithms enables part-per-million sensitivity. Personalis’ innovative methods are covered by its broad range of early and subsequent intellectual property filings.
Going beyond other tumor-informed MRD assays, NeXT Personal also simultaneously detects and quantifies clinically relevant mutations in circulating tumor DNA (ctDNA) that may be used in the future to help guide therapy, when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants which can emerge and change over time, especially under therapeutic pressure.
“With this launch, Personalis is extending what an MRD product can deliver,” said John West, Personalis’ Chief Executive Officer. “With its dramatic increase in sensitivity, we expect to address a range of tumors which were out of reach with earlier technologies. With its broader information content, we also go beyond detection of a tumor, to provide the additional characterization needed to understand and eventually help manage disease.”
“NeXT Personal addresses the need for higher sensitivity assays, opening the door for earlier detection and more sensitive monitoring of patient response to therapy across a broader range of cancers and stages. Today’s release is targeted towards biopharma partners and clinical collaborators. In 2022, we plan to release NeXT Personal as a clinical test, which we expect will yield opportunities for earlier intervention and treatment for cancer patients,” said Dr. Richard Chen, Personalis’ Chief Medical Officer and SVP of R&D.