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DxS is submitting its TheraScreen KRAS test for premarket approval to the US Food and Drug Administration, according to a company official.

“We are using a modular PMA approach,” DxS Stephen Little said.

A modular PMA is a process where data on different aspects of the diagnostic, for example analytical, manufacturing, and clinical, can be submitted when they are complete rather than waiting for all modules to be available prior to submission.

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The Wall Street Journal reports that Russia's announcement of a coronavirus vaccine approval was met with concern as safety testing has not yet been completed.

New Scientist writes there aren't much data available on the accuracy of the two rapid COVID-19 tests the UK plans to roll out.

In PNAS this week: downstream effect of oncoprotein fusion, epigenetic changes influence tRNAs in colon cancer, and more.

Nature News reports that recent proposed changes to the US National Science Foundation have raised concerns about a shift away from the agency's focus on basic research.

Aug
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As worldwide COVID-19 cases continue to rise, there is a significant need to increase testing and population surveillance capacity.

Aug
19
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This webinar will present a case study from in vitro diagnostics developer SpeeDx on its experience building a complete sample-to-result workflow — encompassing instrumentation and data analysis software — for its qPCR-based ResistancePlus MG Mycoplasma genitalium assay.

Aug
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Aug
26
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Alzheimer’s disease is genetically complex with no meaningful therapies or pre-symptomatic disease diagnostics.