RAPID ACCELERATION OF DIAGNOSTICS (RADX) PROGRAM: TECH PROJECT # 6808: SALIVA-BASED SARS-COV-2 RAPID DIAGNOSTIC TEST

Salignostics is applying cutting-edge technology which transforms saliva into a reliable body-fluid for lateral flow immunoassays (LFIA) for the detection and diagnosis of a range of medical conditions, including the SARS-CoV-2 virus. Saliva has over 5,000 different proteins and its composition makes it a body fluid with significant diagnostic potential, yet saliva-based diagnostic tests are at present virtually non-existent. The LFA-based technology developed by Salignostics addresses the challenges in inherent in identifying biomarkers in oral fluid. The platform  is inexpensive, safe, simple to manufacture and does not require special equipment. since saliva is collected by the end user through the insertion of a clinically approved non-invasive collection unit into the oral cavity. For this project, we aim to develop a dedicated analytical unit of the device including a unique diagnostic LFIA strip for SARS-CoV-2 virus detection. The ability to diagnose medical conditions through saliva represents a unique innovation within the COVID-19 Rapid Diagnostic Testing (RDT) space because it is an easy test to perform, always available, and does not require skilled personnel. Salignostics' disruptive technologies have been successfully applied as a device prototype to detect pregnancy. Preliminary trials for the detection of Cardiac Troponin and Malaria have been carried out successfully and will inform prototyping for the proposed solution.