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According to multiple sources in Washington, DC, the FDA has been informing stakeholders in policy circles of the decision.
The US Supreme Court decision cleared the way for large-scale sequencing or drove prices to unsustainable levels, depending on your opinion.
A hospital study demonstrated an average total cost saving of around $25,000 for each patient with candidemia.
The new assays — one targeting 17 genes and one targeting 77 genes — are based on the CAPP-Seq technology developed by Stanford University
Merck is hoping NanoString's multiplex platform can support gene expression signatures that will better predict which patients will respond to checkpoint inhibitors like its Keytruda.
Clinical MDx firm OmniSeq has been an early-access user of the research-use-only assay and is working on validating it to predict checkpoint inhibitor response.
The group said the model must address analytic validity, clinical validity, clinical utility, and ethical, legal, and social implications of these tests.