Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.
A Personalized Medicine Coalition-funded study has found that NGS-based testing is moderately cost effective but that access to targeted treatments remains a hurdle.
Investigators from a variety of clinical sites found that the company's liquid biopsy test was more successful in finding actionable mutations in patients than tumor tissue.
The diagnostic can now be used to identify a wider range of patients with stage III or metastatic NSCLC who may benefit from first-line treatment with Keytruda.
As of July 1, the Guardant360 test will be considered medically necessary for aiding therapy selection in advanced lung cancer for health plan members of EviCore.
A study presented at the AACR meeting showed that Resolution's ctDx-Lung assay reported more oncogenic fusions than Guardant360 in NSCLC patients.
Funds raised will help accelerate commercialization of the firm's InVisionFirst-Lung liquid biopsy test and support development of the firm's platform for new indications
The study adds to growing evidence around the utility of cell-free DNA testing in lung cancer patients, while highlighting shortcomings of the approach.
The ctDNA test will be covered for all US fee-for-service Medicare patients with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.
Data being presented at the upcoming AACR meeting show that Guardant's liquid biopsy test provided more accurate and rapid mutation detection than tissue genotyping.