Biocartis' Idylla called some colorectal cancer samples negative that Sysmex Inostics's OncoBEAM called positive, but the clinical implications may be complex.
The firm believes that physicians can use information from the cell-free DNA analyzed by the assay to determine whether to use anti-EGFR drugs during treatment.
The FDA also cleared a 23andMe genetic health risk report for a syndrome associated with a higher risk of developing hereditary colorectal cancer.
Sysmex accuses 13 Beckman Coulter instruments of infringing 11 claims in the patent, which covers a system analyzer and a computer program.
The firms said they will integrate their capabilities and competencies to offer solutions to global pharmaceutical customers.
The FDA cleared LabCorp's assay for quantitative determination of total cholesterol, high density lipoprotein cholesterol, triglycerides, and apolipoprotein B.
The mobile approach enables stroke patients to be assessed within the three-hour window for stroke treatment.
The firm's nanotechnology-enabled, AI-based, machine learning tool identifies biomarkers in blood samples and produces results in 10 to 30 seconds.
The system is designed to provide a quantitative determination of red blood cells and total nucleated cells in CSF.
Roche received several clearances, including for its Cobas CT/NG assay and for modifications to previously cleared blood clotting systems.