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The firm had been in stealth mode, but hopes to now attract partners to further commercialize its system for decentralized testing.
Bringing testing closer to patients could be helpful, provided enough tests and instruments can be manufactured and distributed.
Droplet digital PCR tests for SARS-CoV-2 can potentially detect the very low viral loads seen in asymptomatic and convalescent cases.
The agency provided an overview of its policies regarding COVID-19 test regulations, as well as additional color and clarification, in a webinar.
The Foundation for Innovative New Diagnostics is tracking commercial coronavirus diagnostics development project, with the goal of guiding procurement.
A number of manufacturers say that the shortage of swabs and transport media for facilitating SARS-CoV-2 testing that clinicians are facing will soon abate.
Test makers are preparing to ramp up production of new SARS-CoV-2 assays and designated testing systems in anticipation of increased demand.
The firm will be validating the test with collaborators in China, and plans to pursue Emergency Use Authorization both in China and the US.
Directing lab-developed tests through the emergency use authorization process has brought to light reagent supply shortages and other hurdles.
SARS-CoV-2 viral material is available for test validation, and the FDA is conducting a rolling review process with an abbreviated submission template.
Los Angeles brought and settled a civil enforcement action against the makers of an at-home test for SARS-CoV-2, NPR reports.
The Guardian reports that Cancer Research UK is cutting its research funding by £44 million.
Technology Review examines factors affecting SARS-CoV-2 testing turnaround times.
In PNAS this week: mapping of ancient human migrations in Europe, recurrent gene fusion in breast cancer, and more.