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Backed by large public companies and growing prospective data, the first molecular blood tests to screen for multiple cancers are approaching commercialization.
The collaboration builds on an oligonucleotide supply agreement the partners signed in 2019 for Clear Labs' nanopore sequencing-based food safety testing.
The company, founded earlier this year, is developing a technology for the detection of low-frequency genetic mutations for diagnostic applications.
The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.
Presentations largely reflected negatively on the utility of PD-L1 for stratifying response, but pivotal new data on tumor mutational burden as assessed by Foundation Medicine's genomic sequencing panel.
PGDx has the exclusive rights to develop both tissue- and blood-based diagnostics using MSK’s TMB-related intellectual property.
Groups from Austria, Spain, Germany, and the US demonstrated that the GeneReader can reliably detect cancer mutations in tissue and liquid biopsy samples.