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The tool, which has been validated in two independent patient cohorts, uses artificial intelligence to predict patients likely to benefit from upfront FOLFOX.
The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
Negative results in recent trials have highlighted the challenges that newer genomic test makers must overcome in proving methods for personalized CUP treatment.
In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
Keytruda and Ibrance demonstrate activity in molecularly defined populations, while a new cohort will explore Gilotrif in tumors with NRG1 fusions.
The company has formalized an existing relationship by acquiring Pharmatech, hoping to directly integrate the firm's "right on time" trial matching service with its own molecular testing.
Caris will use its whole-transcriptome sequencing assay and Molecular Intelligence Trials service to identify patients for a phase II clinical trial.
Tissue-agnostic drug development approaches have their own set of scientific and financial considerations, but some drugmakers are taking on those challenges.
The approval of two molecularly targeted, tissue-agnostic therapies, has shown researchers that there is a path forward for other pan-cancer markers.