Molika Ashford covers personalized medicine and molecular diagnostics for GenomeWeb.
As labs implement TMB workflows in-house, studies are showing that its is possible to validate assays with cutoff points remaining stable across complex clinical cohorts and in different drug contexts.
The company believes the multi-omic approach it has honed for early cancer detection can also glean predictive signatures of drug response from both tumor and immune signals.
Researchers studied isolated CTCs along with real-world patient data and found that patients with blood-borne HER2 mutations may respond to anti-HER2 treatment.
The company said it is on track to complete a clinical validation by the end of next year, after which it would launch its assay for clinical use.
The company is on track to submit Guardant360 to the FDA in the third quarter, but also expects to see pan-cancer reimbursement much sooner.
Biocartis' Idylla called some colorectal cancer samples negative that Sysmex Inostics's OncoBEAM called positive, but the clinical implications may be complex.
While the oncology field moves toward NGS panel testing, the drugmaker has launched a program subsidizing single-gene testing for advanced melanoma patients.
The firm has joined forces with AstraZeneca, the IASLC, and the Global Lung Cancer Coalition, with a goal to double five-year survival rates by 2025.
Practical, technological, and systemic challenges are putting pathologists in tough positions, facing competing demands for molecular analysis of limited biological samples.
Authors concluded that all three assays — Oncotype DX, EndoPredict, and Prosigna — met Canadian thresholds for cost-effectiveness and urged caution in considering the findings.