After reviewing more than 100 studies, the panel issued recommendations focused on women with a personal or family history of BRCA1/2-related cancers or high-risk ancestry.
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 FDA center of excellence has engaged the technology vendor to incorporate real-world evidence into regulatory decision-making for precision oncology treatments.
This is the third drug the agency has approved with a pan-cancer indication.
The firm is developing a biomarker panel to detect mutations in mesenchymal cells, with the goal of guiding drug treatment and improving earlier patient intervention.
The two companies will work together to bring the point-of-care pretreatment diagnostic based on the XDX-01 biomarker to market in 2020.
The program, called Project Facilitate, aims to help oncologists request access to investigational drugs but may only simplify part of the process.
The Cancer Journal documented 25 cases where inappropriate tests were ordered, variants were interpreted incorrectly, and wrong results were reported to patients.