On January 7, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the launch of the NeXT Dx Test to help oncologists identify potential therapies and clinical trial options for cancer patients (Press release, Personalis, JAN 7, 2020, View Source [SID1234552810]). The Personalis NeXT Dx Test is one of the first cancer diagnostic platforms to profile approximately 20,000 genes in both the tumor exome and transcriptome, providing a comprehensive genomic testing solution that goes beyond many existing cancer diagnostic panels that focus on a few hundred genes. The Personalis NeXT Dx Test includes advanced analytics to provide a diagnostic report on genetic alterations in medically-important cancer genes, as well as emerging immunotherapy composite biomarkers of medical importance. Additionally, immunotherapy-related biomarkers such as microsatellite instability (MSI) status and tumor mutational burden (TMB) are included in the clinical report.
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"With new cancer immunotherapy and combination therapies, there is an increasing need for the development of more advanced composite biomarkers that can model the complex biology driving the response and resistance to cancer therapy. Our NeXT Dx Test provides oncologists with clinical reports on key diagnostic markers driving therapies today as well as provides information that can support the identification of new, advanced biomarkers. With the NeXT Dx Test, we look forward to expanding engagements with both leading clinical cancer centers as well as biopharmaceutical companies looking to push forward cutting-edge precision medicine in cancer," said Dr. Richard Chen, MD, Chief Scientific Officer at Personalis.
About NeXT Dx Test
The NeXT Dx Test, optimized for formalin-fixed, paraffin-embedded tumor samples, is a laboratory-developed test performed at Personalis’ CAP-accredited and CLIA’88-certified laboratory. The test utilizes ImmunoID NeXT, a high-accuracy, clinical-grade, next-generation sequencing and analysis platform, to report base substitutions, insertions/deletions, gene fusions, and copy number alterations in cancer driver genes of clinical significance. Additionally, MSI status is reported based on five canonical loci (BAT25, BAT26, NR-21, NR-24, and NR-27), and TMB status is reported by leveraging the exome-wide analysis of non-synonymous somatic mutations. Based on the tumor’s molecular profile, the report delivers relevant therapy recommendations and appropriate clinical trial matches. Each case is reviewed by a team of board-certified molecular geneticists and genetic counselors. Test results are electronically delivered to the ordering clinician.
About ImmunoID NeXT Platform
ImmunoID NeXT is a universal cancer immunogenomics platform that consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and its tumor microenvironment from a single sample. The platform represents an end-to-end solution for immuno-oncology and supports precision oncology biomarker discovery applications. It combines the pioneering NeXT assay (whole exome and transcriptome sequencing), sophisticated analytics engines, and quality support to provide researchers with comprehensive immunogenomic data to drive their drug development programs.