Company Plans to file for an Emergency Use Authorization (EUA) and 510(k) Application in the Current Quarter (Q3, 2020)
Aditxt Therapeutics, Inc. (Aditxt) (the “Company”) (Nasdaq: ADTX), a life sciences company developing technologies focused on improving the health of the immune system through immune monitoring and reprogramming, today introduced AditxtScore™ for COVID-19 to be used in detecting antibodies against SARS-CoV-2 antigens, as validated in studies performed by Stanford Blood Center, headquartered in Palo Alto, California.
AditxtScore™ for COVID-19 is a double-multiplex assay that can be used to detect and differentiate various antibody isotypes (IgG, IgM, IgA) against multiple SARS-CoV-2 antigens (e.g. RBD, S1, NP) simultaneously in a single reaction. Currently, one of the most widely used platforms, ELISA, can only detect one antibody isotype against one antigen at a time. AditxtScore™ for COVID-19 increases the resolution of results obtained for each antibody isotype thereby enhancing sensitivity for monitoring changes in these values over time. Due to the enhanced specificity and sensitivity of this comprehensive antibody profiling system, false positive and false negative results have proven to be significantly reduced when testing for the antibodies produced to SARS-CoV-2, thereby expanding its utility beyond a tool used in epidemiology. Therefore, and importantly, AditxtScore™ for COVID-19 can serve as a valuable tool to evaluate immune responses to SARS-CoV-2 vaccines in clinical settings.
Aditxt plans to file for an Emergency Use Authorization (EUA) followed by a 510(K) application with the U.S. Food and Drug Administration by the end of the current quarter (Q3, 2020). Additionally, Aditxt is planning its operational capabilities in anticipation of beginning pilot programs utilizing AditxtScore™ for COVID-19 in Q4, 2020, with the goal of making AditxtScore™ commercially available starting in Q1, 2021.
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