RADX TECH - MAXIM BIOMEDICAL INC. SARS-COV-2 ANTIGEN RAPID TEST

Maxim Biomedical, Inc. (Maxim), headquartered in Maryland, USA, was formed in May 2005 to develop and provide high quality, in-vitro diagnostic (IVD) and Point-of-Care (POC) testing solutions. Our FDA cGMP approved and ISO13485:2016 certified facility is equipped with state-of-the-art laboratories for in-vitro diagnostic production. In response to the COVID-19 pandemic and in collaboration with the US Department of Defense (DoD), Maxim has in-house developed the Maxim SARS-CoV-2 Antigen Rapid Test Kit as a single-use qualitative lateral flow immunoassay to detect the circulating antigens of SARS-CoV-2. This point-of-care (POC) test is currently suitable for use with nasopharyngeal specimens from individuals suspected of COVID-19 infection and requires 10 minutes for a complete readout. A small-batch production (5000 units) of Maxim’s SARS-CoV-2 Antigen Rapid Test prototype has undergone and completed performance evaluation testing by the DoD’s Defense Biological Product Assurance Office (DBPAO) with highly promising results (see Prior Work). Optimizations are already ongoing to improve the sensitivity and specificity and to ensure that the product can be manufactured in a scalable manner. Maxim is currently seeking funding to rapidly scale up production capacity to be able to meet DoD’s demand of an estimated minimum of 1 MM tests/month by 07/15/20. Based on our current stage of development, we believe that Maxim’s Rapid Antigen Test can meet the milestones of this RADx program to rapidly deploy test kits to the general public.