Development of CoroDetecT, a skin test for SARS-CoV-2 infection

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The following contains proprietary/privileged information that HDT Bio Corp requests not be released to persons outside the government, except for purposes of review and evaluation. PROJECT SUMMARY/ ABSTRACT Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2, the cause of the COVID-19 pandemic, rapidly spread worldwide and has had, and continues to have, a devasting impact on the global economy and individual quality of life. Large scale testing and expedient testing at regional and national levels is required for improved understanding of SARS-CoV-2 infection levels to inform public health control measures and guide a return to normality. While diagnostic strategies using nucleic acid- and antibody-detection tests have emerged, practical and scientific/clinical limitations inherent to both these platforms have left testing gaps. The rapid waning of antibody titers that is a natural phenomenon common to coronavirus immunity has been reported after SARS- CoV-2 infection (3-5), limiting the capability of antibody-based tests to assess both infection and immunity. Detailed immunological evaluations are, however, now indicating that antigen-specific T cell responses generated by both symptomatic and asymptomatic SARS-CoV-2 infection are more stable and longer lasting. Thus, there is significant merit in developing commercial tests that detect antigen-specific T cell responses for integration into the overall COVID-19 epidemiology and containment strategy. The overall goal of this program is to develop a T cell-based skin test (CoroDetecTTM) to detect and assess history of SARS-CoV-2-infection. Importantly, unlike most other testing systems, we will emphasize the production of a test that has minimal components, does not require laboratory support, and provides results directly to the subject being tested.