Research & Development
Aditxt Submits Two Requests for Emergency Use Authorization to FDA for AditxtScore for COVID-19 Tests Which Measure the Quantity and Quality of Antibodies Against COVID-19 and its Variants Including Omicron
19 January 2022 - - US-based biotech innovation company Aditxt, Inc (NASDAQ: ADTX) has submitted two EUA applications for AditxtScore for COVID-19, the company said.

The company said this lab-developed blood test provides a more comprehensive profile of the body's immune response to COVID-19.

AditxtScore for COVID-19 not only indicates levels of protective immunity against the virus, but also seeks to map out the difference in response to its common variants, including Omicron.

Aditxt's EUA submissions are for tests designed to, among other things: reveal levels of antibodies neutralizing COVID-19; and quantify the level of antibodies that attack various targets of the virus, including the spike and nucleocapsid proteins.

The granularity of AditxtScore for COVID-19 is of crucial importance as spike protein antibodies are generated in response to the vaccine and natural exposure to the virus.

Antibodies to the nucleocapsid protein are, in contrast, only produced in response to exposure or infection by COVID-19.

In mid-2021, Aditxt launched a high complexity, Clinical Laboratory Improvement Amendments certified AditxtScore Immune Monitoring Center in Richmond, Virginia.

Before November 15, 2021, COVID-19 LDTs were not reviewed by the FDA and fell under the guidelines of CLIA. On November 15, the Department of Health and Human Services changed course on the regulation of COVID-19 LDTs, allowing the FDA to require providers to submit EUA applications for such tests.

Aditxt develops technologies focused on improving immune system health through immune monitoring and reprogramming.


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