Companion Diagnostics
News on companion diagnostics and drug/test co-development.
FDA Launches Pilot Program to Determine Performance Criteria for Lab-Developed CDx Tests
Through the voluntary program, the agency will ask drug manufacturers for performance information for the tests used to enroll patients in pharmaceutical clinical trials.
Foundation Medicine Blood Test Gets FDA Approval as CDx for Pfizer's Braftovi in Colorectal Cancer
The FDA has approved the FoundationOne Liquid CDx assay to identify patients with BRAF V600E alterations eligible for treatment with Braftovi.
Foundation Medicine, Merck KGaA to Collaborate on Companion Diagnostics
The companies will develop FoundationOne Liquid CDx and FoundationOne CDx as CDx tests in the US market for selected Merck KGaA marketed and pipeline treatments.
Guardant Health Secures New Commercial Payor Coverage for Liquid Biopsy Cancer Profiling Test
With new coverage from Anthem Blue Cross and Blue Shield, Aetna, and Humana, the firm's Guardant360/Guardant360 CDx assay is now covered by all major commercial health insurers.
The firm reported Thursday its Q1 revenues declined 30 percent as COVID-19 revenues dwindled but non-COVID organic revenues grew 6 percent.