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Madeleine covers PCR, nucleic acid amplification, and sample prep technologies for GenomeWeb.
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.
Comparing the BD and Quidel rapid antigen tests showed they performed similarly despite sensitivity differences in initial FDA filings.
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.
The firm is using ddPCR to support testing 3,000 samples per day with a turnaround time of approximately 24 hours
Grassroots efforts are leading the way in a number of commercial and non-commercial screening tests in development.