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 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.
