BioVaxys Technology Corp. announced that it has initiated the clinical development program for Covid-T™, the Company's novel diagnostic platform for detecting T-cell activity. The US Food and Drug Administration has tentatively agreed to permit that BioVaxys can file for a pre-Emergency Use Authorization for Covid-T™. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Covid-T™ addresses an unmet need for a low-cost, easy-to-administer, and accurate tool to test for the presence of T-cells which may offer lasting protection against SARS-CoV-2. It is believed that detection of T-cells can potentially identify safe and/or at-risk populations. Covid-T™ also provides an ability to evaluate the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T-cell immunity. Mass availability of Covid-T™ would complement antibody testing and various public health risk mitigation strategies. Current methods of measuring T-cell immunity require drawing blood from the test subject, followed by a time-consuming and expensive analysis of the blood sample at laboratories possessing specialized equipment. Covid-T™ is based on the well-established concept of Delayed Type Hypersensitivity, the oldest and most reliable test of human T lymphocyte function. The process involves an intradermal skin prick of an immunogenic composition of the SARS-CoV-2 S-protein, where an inflammatory response develops 24-72 hours after skin exposure to the s-spike antigen. BioVaxys anticipates that once clinical testing is complete, Covid-T™ would have the potential for detecting differences in T-cell responses between the original SARS-CoVC-2 virus and the two new strains of SARS-Cov-2 the had originally been identified in the UK and South Africa-B.1.1.7 and 501Y.V2, respectively but which are spreading worldwide. BioVaxys has prepared the clinical development plan for Covid-T™, and engaged global regulatory advisory group Rio Pharmaceutical Services ("RPS") of Bridgewater, NJ, to provide strategic regulatory guidance, prepare an FDA pre-submission guidance package, recommend regulatory pathway, and support BioVaxys on the registration filing. RPS has provided pharmaceutical and medical-device advisory services across the entire drug, biologic and device development and approval spectrum of the pharmaceutical industry since 2000. Collectively, the RPS team of pharmaceutical industry executives offers nearly 150 years of experience in providing advice and support services for medical, scientific, clinical-trial and regulatory issues to clients including a majority of Fortune 500 pharmaceutical companies. Since Covid-T™ requires a biological substance to be placed intradermally, a nonclinical study will be needed to establish the risk profile prior to the start of clinical studies. BioVaxys plans to shortly conduct a GLP animal toxicology study, is currently evaluating proposals from Contract Research Organizations, and is in the process of obtaining the appropriate cell lines, expression systems, and licenses so as to produce its own supply of SARS-CoV-2 s-spike protein.