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The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).
Results of the study, published in JAMA, highlight ongoing and future challenges in translating the promise of comprehensive genomics into clinical benefit.
On the heels of the WINTHER study, the consortium has planned a new trial called MERCURY, and will launch a blood and tissue repository.
Two new studies have uncovered expression-defined T cell subsets that seem to coincide with better or worse outcomes in breast cancer or non-small cell lung cancer.
The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.
New trial data presented at ASCO highlights the utility of checkpoint inhibitors, alone or with chemotherapy, across PD-L1 expression groups.
This data is helping the agency understand how precision oncology drugs and tests are prescribed outside of clinical trials and in the broader cancer community.
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.
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.
BMS amended an ongoing Phase III study of Opdivo and Yervoy to evaluate outcomes based on tumor mutational burden using Foundation Medicine's NGS companion diagnostic.