Benzinga | Jan 18, 2022 08:34AM EST

Aditxt Reports Submission Of 2 Requests For Emergency Use Authorization To FDA For AditxtScore For COVId-19 Tests To Measure Quantity, Quality Of Antibodies Against COVID, Variants Including Omicron

Aditxt meets the timeline imposed by the FDA for laboratory-developed tests ("LDT"s) to request Emergency Use Authorization ("EUA") by January 14th

AditxtScore(tm) for COVID-19 will continue to be available during the FDA review

RICHMOND, Va.--(BUSINESS WIRE)-- Aditxt, Inc. ("Aditxt," or the "Company") (NASDAQ:ADTX), a biotech innovation company with a mission to advance humanity's transition to the "Age of Immunity," has submitted two EUA applications for AditxtScore(tm) for COVID-19. This lab-developed blood test provides a more comprehensive profile of the body's immune response to COVID-19.

AditxtScore(tm) 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: (i) reveal levels of antibodies neutralizing COVID-19; and (ii) quantify the level of antibodies that attack various targets of the virus, including the spike and nucleocapsid proteins. The granularity of AditxtScore(tm) 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 (CLIA) certified AditxtScore(tm) 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 (HHS) changed course on the regulation of COVID-19 LDTs, allowing the FDA to require providers to submit EUA applications for such tests.

"Understanding the levels of antibodies to COVID-19 and the effectiveness of these antibodies to neutralize the virus is key to a successful national and global response to the pandemic. AditxtScore(tm) 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," said Aditxt Co-Founder and CEO Amro Albanna.