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

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.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 NARRATIVE Practical tools are required to help health surveillance programs during the COVID-19 pandemic. Using the observation that antigen-specific T cell responses outlast circulating antibodies following coronavirus infections, we will develop a T cell-based skin test to detect immunity to SARS-CoV-2 infection. This practical test will address a critical gap in the fight against this devastating disease.