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

Rhea-AI Summary

Aditxt has officially submitted two Emergency Use Authorization (EUA) applications for its AditxtScore™ COVID-19 test to the FDA, meeting the January 14 deadline. This comprehensive blood test assesses the immune response to COVID-19 and its variants, including Omicron. Notably, the test evaluates levels of neutralizing antibodies to the virus and those targeting its spike and nucleocapsid proteins. AditxtScore™ continues to be available during the FDA review process, aiming to provide critical insights into COVID-19 immunity.

Positive

• Submitted two EUA applications for AditxtScore™ for COVID-19, meeting FDA timeline.
• AditxtScore™ provides comprehensive immune response profiling against COVID-19 and its variants.

Negative

• None.

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

AditxtScore™ 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™ for COVID-19. 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: (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™ 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™ 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™ 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.

About Aditxt:

Aditxt develops technologies focused on improving immune system health through immune monitoring and reprogramming. Aditxt’s immune monitoring technology is designed to provide a personalized, comprehensive system immune system profile. Aditxt’s immune reprogramming technology, currently preclinical, is designed to retrain the immune system to induce tolerance to address rejection of transplanted organs, autoimmune diseases, and allergies. AditxtScore™ for COVID-19 is Aditxt’s proprietary immune profile technology to equip people with information about their level of protection.

For more information, please visit: www.aditxt.com and www.AditxtScore.com

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, the Company’s ongoing and planned product and business development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section titled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the Securities and Exchange Commission. All such statements speak only as of the date made. The Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220118005534/en/

Media and Investor Relations Contact:

Aditxt Investor Communications

ir@aditxt.com

Source: Aditxt, Inc.

FAQ

What is Aditxt's recent announcement regarding the FDA and COVID-19 tests?

Aditxt has submitted two Emergency Use Authorization (EUA) applications for its AditxtScore™ COVID-19 test to the FDA, meeting the January 14 deadline.

What does AditxtScore™ for COVID-19 measure?

AditxtScore™ assesses the immune response to COVID-19, including levels of neutralizing antibodies and the immune response to different viral variants.

Will AditxtScore™ for COVID-19 be available during the FDA review?

Yes, AditxtScore™ will continue to be available while the FDA reviews the EUA applications.

What are the key features of AditxtScore™ for COVID-19?

The test reveals levels of antibodies that neutralize COVID-19 and quantifies antibodies targeting spike and nucleocapsid proteins.

When did Aditxt submit its EUA applications to the FDA?

Aditxt submitted its EUA applications in January, ahead of the January 14 deadline imposed by the FDA.