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Results from the Phase II INSPIRE study showed that change in ctDNA from baseline, as gauged by customized assays, predicted response to pembrolizumab.
The firm initially plans to apply the method, which measures the size of specific macrophages in blood, to predict lung cancer immunotherapy response.
The company expects to garner clearance for its platform in the US first for Lynch syndrome as it builds additional evidence for an immunotherapy application.
The work suggests mass spec can more accurately assess levels of immunotherapy targets like PD-L1 than conventional clinical approaches.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
Promega will seek to expand use of the assay in Europe while it works through regulatory review of the test for companion diagnostic use in the US and Asia.
The platform was used to subtype patients in a Phase II trial and found that patients in the claudin-low subgroup had the best two-year progression-free survival on pembrolizumab.
The project is collaborating with nine biopharma companies to combine more real-world clinical data with genomic data.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
The groups have written draft recommendations and are now asking for public comment from pathologists and other stakeholders.
Two COVID-19 vaccine developers have released their trial protocols to build public trust, the New York Times reports.
A new analysis finds the rapid COVID-19 test from DnaNudge to be highly accurate, Reuters reports.
In Science this week: global citizens' assembly on genome-editing technologies proposed, epigenetic markers predict metformin response, and more.
According to the Verge, many US states are not including positive results from rapid COVID-19 testing in their case numbers.