Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.
With exome sequences from more than 600 metastatic breast tumors, researchers identified genomic alterations related to tumor progression, treatment response, and patient outcomes.
At the ACMG meeting, a Children's Hospital of Philadelphia researcher described finding relatively high rates of hereditary cancer variants in tumor sequence data.
The hospital is in the process of clinically validating a sequencing pipeline for its pediatric cancer patients, with the goal of demonstrating clinical utility.
With RNA sequencing and other data, researchers gauged neoantigen formation, immunoediting, and clonal evolution in non-small cell lung cancers.
Researchers at UC Santa Cruz have found patterns in RNA sequencing data that have led to possible treatments for cancers with no actionable mutations.
The projects, organized by Friends of Cancer Research in the US and the Quality Assurance Initiative Pathology (QuIP) in Germany, are comparing different TMB assays.
The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.