Genomics: Clinical Implementation
This channel includes news headlines and educational resources regarding the clinical implementation of genomics assays, including development, validation, quality control, standardization, and the practical and commercial considerations for labs adopting these tests.
GeneCentric Begins Study to Validate RNA Gene Signature Test in Bladder Cancer
GeneCentric investigators will assess the ability of the FGFR predictive response signature to identify bladder cancer patients who may benefit from targeted therapy.
FoundationOne Liquid Biopsy Assay Gets FDA OK as Companion Diagnostic for Takeda's Exkivity
Foundation Medicine said its assay is the only blood-based comprehensive genomic profiling platform to have gained this approval for Takeda's EGFR drug.
Personalis to Test MRD Assay in Triple-Negative Breast Cancer Trial With ABRCC, Criterium
The company has partnered with the Academic Breast Cancer Consortium and Criterium to assess its test in a prospective trial with five years of follow-up.
Tempus Gains FDA Premarket Approval for NGS Solid Tumor Profiling Test
The xT CDx is a 648-gene next-generation sequencing test that can help guide treatments for colorectal cancer patients with targeted therapies.
Pacific Edge Ramps up Clinical Utility Studies, Commercial Efforts Behind Bladder Cancer Test
The New Zealand-based diagnostics firm is hoping the coming year will be a tipping point toward new guideline inclusion and broader adoption.