News on molecular markers used to guide cancer treatment, assess prognosis, or detect relapse.
The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.
Presentations largely reflected negatively on the utility of PD-L1 for stratifying response, but pivotal new data on tumor mutational burden as assessed by Foundation Medicine's genomic sequencing panel.
The company has highlighted the study as evidence that its test would outperform Roche's FDA-approved liquid biopsy assay if implemented in the clinic.
The analysis of HER2 and HER3 mutation carriers emphasizes how these studies can lead both to broadening and to narrowing of the patient populations for targeted drugs.
The new guidelines said ROS1, KRAS, BRAF, MET, RET, and HER2 should be included in targeted and expanded panels.
An extended labeling claim has added detection of three additional EGFR mutations to help ID NSCLC patients for whom Boehringer Ingelheim's Gilotrif is indicated.
This is the first US Food and Drug Administration approval for a drug based solely on data from a basket study.
The researchers found that most advanced EGFR-mutant lung cancer patients harbored changes in an average of two to three other oncogenes.
The agency is excluding certain advanced diagnostic lab tests and molecular pathology tests from a billing regulation that created administrative headaches for many labs.
The recent study highlights strengths and weaknesses of numerous platforms and may help end users choose the best assay for their circumstances.