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 - 12:30AM
Business Wire
Aditxt meets the timeline imposed by the FDA
for laboratory-developed tests (“LDT”s) to request Emergency Use
Authorization (“EUA”) by January 14th
AditxtScore™ for COVID-19 will continue to
be available during the FDA review
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.
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Media and Investor Relations Contact: Aditxt Investor
Communications ir@aditxt.com
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