regulatory approval
Prenetics' ACT Genomics Profiling Test for Solid Tumors Receives FDA Clearance
The regulatory clearance of ACTOnco comes on the heels of Prenetics' acquisition of a majority stake of ACT Genomics last month.
FDA Approves Foundation Medicine Blood Test as CDx for Rozlytrek
FoundationOne Liquid CDx, a liquid biopsy test, is the only blood-based CDx approved for the targeted cancer therapy.
FDA Approves Thermo Fisher HLA Typing Test as CDx for Immunocore Uveal Melanoma Therapy
The marketing authorization makes Thermo Fisher’s SeCore CDx HLA Sequencing System the first and so far only commercially available HLA typing companion diagnostic.
Pillar Biosciences Receives China Approval for Colon Cancer Companion Diagnostic Assay
The OncoReveal Dx Colon Cancer Assay is intended for use on the Illumina MiSeq Dx, and now has approvals in China, the US, and Europe.
The company achieved two major milestones this year with the launch of its Guardant Shield test and Medicare reimbursement for its Guardant Reveal test.