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Molika Ashford covers personalized medicine and molecular diagnostics for GenomeWeb.
In its IPO prospectus, the company shared plans to broaden the use of its methylation technology from cancer screening to diagnostics and residual disease monitoring.
The company is using newly raised funds to support a disseminated trial model, which it said will help it keep its plans to finish the study by the end of 2021.
The company was able to ramp up recruitment for its pivotal ECLIPSE trial after hurdles caused a falloff during the earlier months of the COVID-19 pandemic.
The gene expression test retrospectively identified rheumatoid arthritis patients significantly less likely to respond to TNF inhibitor therapy.
The company recently had a second pre-submission with FDA and expects to begin a prospective trial of its test in the second half of this year.
The company recently said it was discontinuing development of its original and only in-house developed assay after a failed clinical validation.
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.
Researchers concluded that there has been significant expansion of coverage for ctDNA assays over the past four years, but policies remain very heterogeneous and often limited.
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.
At the American Society of Clinical Oncology's virtual meeting, investigators presented two new studies of BluePrint classification patterns.