Arbor Vita Launches Open Platform COVID-19 Antibody Test Expanding Access To Higher Quality Diagnostics

Arbor Vita announced today the availability of its CoVisa™ IgG ELISA-based test for antibodies associated with the novel coronavirus (COVID-19). The test has been found to have a 100 percent sensitivity (positive percentage agreement), and 99.24 percent specificity (negative percentage). Additional validation testing is ongoing in independent laboratories. The company has notified the U.S. Food and Drug Administration under the Emergency Use Authorization (EUA) process. Arbor Vita's CoVisa™ test presents an opportunity to greatly enhance antibody test availability in the U.S.  Currently there are approximately 26,000 high complexity CLIA labs in the U.S. capable of processing COVID-19 antibody tests on ELISA systems. Approximately 200 to 2,000 of those labs have systems that can run currently available tests on a closed platform, that is on a particular manufacturer's laboratory equipment. CoVisa can be used by the additional 24,000 labs that do not have such equipment. This is especially important since those high complexity CLIA labs will not be able to offer COVID-19 antibody testing after the removal by the FDA of 28 non-functioning antibody tests that do not use the higher accuracy ELISA method. Arbor Vita has commenced production of all elements of its test including reagents within its U.S facilities and will initially deliver 2,000,000 tests by the end of June and expand production to 1,000,000 per day by the end of July.