The method uses standard lab equipment and the nanoswitches can be easily reconfigured and made in large batches at a cost of about $0.01 per reaction.
The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.
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 move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
Mount Sinai researchers investigated four cytokine proteins and found that two of them were elevated in the serum samples of SARS-CoV-2 patients who fared the worst.
A SNP in the pan-SARS E gene has not affected patient results, but has raised concerns about the overall unavailability of commercial primer and probe information.
Belgium's OncoDNA believes that IntegraGen's bioinformatics platform will help it manage more cancer patient data and quickly generate patient-specific treatment reports for clinicians.
