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The NGS assay is designed to help physicians to identify non-small cell lung cancer patients who may benefit from eight targeted therapies.
Qiagen's test detects the most frequently occurring somatic mutations in EGFR in less than four hours using real-time PCR on the Rotor-Gene Q platform.
The study authors cautioned that immunological signatures cannot be predicted from tumor mutational burden or microenvironment analysis of a single biopsy alone.
During the meeting, researchers presented studies on combination immunotherapies and the efficacy of giving molecularly-informed treatments earlier in the disease continuum.
The new approval will allow the use of Qiagen's Therascreen EGFR RGQ PCR Kit as a companion diagnostic for Pfizer's Vizimpro in NSCLC patients.
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.