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20/20 GeneSystems develops and promotes a proteomics product line providing tools for protein analysis for drug companies, biodefense specialists and life sciences research. The company develops and commercializes proprietary diagnostics tests for cancer and infectious disease.
In March 20, 2020, during the COVID-19 pandemic, 20/20 GeneSystems began taking orders for its diagnostic test CoronaCheck COVID-19 Rapid Antibody Test. The tests are chromatographic immunoassays that test a drop of blood in a similar configuration to a pregnancy test. The test detects IgM and IgG antibodies to SARS-CoV-2 which causes COVID-19. In patients infected with the novel coronavirus, the IgM antibody rises within 1 week of infection and IgG withing 14 days. The test which gives a result in 15 mintues is CE approved and used in European countries. 20/20 is requesting Emergency Use Authorization (EUA) from the FDA and is already available to US based public health providers, hospitals, urgent care centersm and occupational health providers. In an evaluation in China on 760 clinical samples, the manufacturers reported 97.2% sensitivity and 92% specificity.
