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.
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.
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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