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The tests will be developed to identify NSCLC patients with ALK fusions and EGFR Exon20 insertion mutations who respond to mobocertinib or brigatinib.
The company's approach combines whole-genome sequencing, CRISPR, liquid biopsy, and gene therapy to target cancer cells with gene fusions.
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.
OneOncology, a network comprising community oncology practices across the US, will bring its patient data to the research-focused partnership.
By allowing rare cancer patients to receive genomic profiling and treatments locally, the study investigators are hoping to expand access to molecularly informed care throughout the US.
Two studies, one positive and one negative, give proponents and skeptics more data to parse in debating whether genomically guided treatment has broad value in lung cancer.
TargetCancer is activating two enrollment sites and setting up a remote consenting process so patients with rare cancers can be seen at local community hospitals.
A consortium convened by Friends of Cancer Research has made progress in quantifying sources of TMB assay discordance and created a new test-alignment software tool.
Analyzing both circulating tumor DNA and circulating tumor cells, investigators could classify patients into groups with significantly higher and lower recurrence risk.
Some oncologists said 10 mutations/Mb is an acceptable TMB cutoff in patients who are out of options, while others worry it will drive immunotherapy use in those unlikely to have a lasting benefit.