Biotech innovation company Aditxt has submitted two applications to the US Food and Drug Administration (FDA) seeking emergency use authorisation (EUA) for its AditxtScore for COVID-19 tests.
The new lab-developed blood test is designed to measure the quantity and quality of Covid-19 antibodies present in the body, including those for its common variants, such as Omicron.
It provides a comprehensive profile of the protective immunity against Covid-19 in the body.
The company said that its immune profile technology AditxtScore for COVID-19 also seeks to explore the difference in response to Covid-19 common variants.
It submitted the applications to the FDA for its AditxtScore for COVID-19 tests, which are designed to measure the level of antibodies that can attack different virus targets, including the spike and nucleocapsid proteins, and reveal levels of antibodies that neutralise Covid-19.
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Aditxt co-founder and CEO Amro Albanna said: “Understanding the levels of antibodies to Covid-19 and the effectiveness of these antibodies to neutralise the virus is key to a successful national and global response to the pandemic.
“AditxtScore for COVID-19 and its decoding of the immune response to SARS-CoV-2 plays a vital role in providing such critically needed information and helping us return to normality.”
During the FDA review, the availability of AditxtScore for COVID-19 will continue.
With the help of AditxtScore for COVID-19, individuals will be able to get a better understanding of their immunity status.
Last year, the company launched the AditxtScore Immune Monitoring Center in Richmond, Virginia.
The facility was certified by the Clinical Laboratory Improvement Amendments (CLIA).