CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
December 2018—Sysmex Inostics announced publication of a study in the Journal of Molecular Oncology (Rowe SP, et al. 2018;12[10]:1661–1672) highlighting the clinical value of blood-based ctDNA mutation testing to complement standard-of-care management of patients with advanced melanoma. Investigators at Johns Hopkins University School of Medicine utilized Sysmex Inostics’ CLIA-certified OncoBeam liquid biopsy tests to examine the clinical utility of ctDNA measurements as an adjunct to radiographic imaging for monitoring disease activity and to inform clinical decision-making in patients undergoing treatment with targeted therapy or immune checkpoint inhibitors.
Plasma mutation analysis was performed with the OncoBeam BRAF and NRAS assay validated in Sysmex Inostics’ CLIA-certified laboratory. Fifty-five patients were evaluated, with OncoBeam demonstrating a sensitivity and specificity for NRAS and BRAF mutation detection in plasma of 86.7 percent and 100 percent, respectively. In addition to high overall agreement with tissue testing, the clinical value of ctDNA was underscored by two patients for whom tissue analysis did not detect a BRAF V600E mutation that was successfully detected in plasma.