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With nearly 7 million COVID-19 cases, the country is expanding near-patient strategies historically deployed for tuberculosis testing for SARS-CoV-2 testing.
The agency provided the update on Wednesday in its weekly virtual town hall and on its FAQ page.
The new method incorporates analysis of the amplification and melt curves and was used to create a single-channel nonaplex test using intercalating dye.
Reported as "nucleic acid amplification test-detectable" units per milliliter, the limits of detection of more than 50 commercial tests differed by 10,000-fold.
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 firm was one of the first to have a COVID-19 test receive EUA from the FDA. It is also developing a COVID-19/flu combo test for which it will seek EUA.
The Warsaw, Poland-based startup expects to submit a rapid SARS-CoV-2 molecular test for EUA and is seeking US manufacturing and distribution partners.
The New York startup is curating available data for all Emergency Use Authorized molecular diagnostic tests for the benefit of the public.
Funding from RADx and NIAID will enable the scale-up of multiplexed viral detection microarrays to 4 million tests per month.
Politico reports that the NYPD DNA database has grown since it announced it would be removing profiles from it.
Forbes reports that a structural biology lab at Oxford University studying the coronavirus was hacked.
Science reports that a Dutch research funding agency is combating a ransomware attack.
In Science this week: set of 64 haplotype assemblies from 32 individuals, and more.