Aditxt Introduces AditxtScore™ for COVID-19 and Announces the Completion of Validation Studies by Stanford Blood Center
August 06 2020 - 8:00AM
via NEWMEDIAWIRE -- Aditxt Therapeutics, Inc. (Aditxt) (the
“Company”) (Nasdaq: ADTX), a life sciences company developing
technologies focused on improving the health of the immune system
through immune monitoring and reprogramming, today introduced
AditxtScore™ for COVID-19 to be used in detecting antibodies
against SARS-CoV-2 antigens, as validated in studies performed by
Stanford Blood Center, headquartered in Palo Alto, California.
AditxtScore™ for COVID-19 is a double-multiplex
assay that can be used to detect and differentiate various antibody
isotypes (IgG, IgM, IgA) against multiple SARS-CoV-2 antigens (e.g.
RBD, S1, NP) simultaneously in a single reaction. Currently, one of
the most widely used platforms, ELISA, can only detect one antibody
isotype against one antigen at a time. AditxtScore™ for COVID-19
increases the resolution of results obtained for each antibody
isotype thereby enhancing sensitivity for monitoring changes in
these values over time. Due to the enhanced specificity and
sensitivity of this comprehensive antibody profiling system, false
positive and false negative results have proven to be significantly
reduced when testing for the antibodies produced to SARS-CoV-2,
thereby expanding its utility beyond a tool used in epidemiology.
Therefore, and importantly, AditxtScore™ for COVID-19 can serve as
a valuable tool to evaluate immune responses to SARS-CoV-2 vaccines
in clinical settings.
Aditxt plans to file for an Emergency Use
Authorization (EUA) followed by a 510(K) application with the U.S.
Food and Drug Administration by the end of the current quarter (Q3,
2020). Additionally, Aditxt is planning its operational
capabilities in anticipation of beginning pilot programs utilizing
AditxtScore™ for COVID-19 in Q4, 2020, with the goal of making
AditxtScore™ commercially available starting in Q1, 2021.
Harpreet Sandhu, Chief Executive Officer of
Stanford Blood Center (SBC), commented, “The AditxtScore™ for
COVID-19 has the potential to be a game changer for our industry.
AditxtScore™ for COVID-19 is a multiplexed platform that has shown
tremendous speed and accuracy, which is extremely critical for
meeting the ongoing COVID-19 challenge. My team and I look forward
to further exploring this platform and potentially collaborating
with Aditxt on future projects.”
Amro Albanna, Co-founder and Chief Executive
Officer of Aditxt, added, “Our vision for AditxtScore™ is to
transform immune diagnosis from reactive testing to proactive
monitoring. The AditxtScore™ platform is a transformative
approach for monitoring and predicting immune responses by
providing meaningful information in a timely manner. Now that
we have successfully completed the validation study of the first
product, our goal is to quickly secure the necessary regulatory
requirements to deploy AditxtScore™ for COVID-19 and contribute to
addressing the current national and global pandemic we are all
facing. The AditxtScore™ platform is built to evaluate the status
of the immune system and the COVID-19 application is only the first
product to demonstrate its potential. We are actively working to
develop AditxtScore™ for other applications, including predicting
immune responses to vaccination and early detection of Type I
Diabetes, among others.”
About Stanford Blood CenterStanford Blood
Center (SBC) is an independent, community blood center that
supplies blood products and testing services to multiple Bay Area
hospitals and is a recognized leader in the fields of transfusion
and transplantation medicine. SBC was created at the Stanford
University School of Medicine in 1978 to meet the complex
transfusion and transplant needs of Stanford Health Care and Lucile
Packard Children’s Hospital Stanford, as well as provide clinical
trial services and specialized blood products for researchers.
Today, the center remains locally focused, serving community
hospitals, patients and donors, while contributing to research and
advancement that impact the world at large. More information is
available at stanfordbloodcenter.org.
About Aditxt TherapeuticsAditxt is developing
technologies specifically focused on improving the health of the
immune system through immune monitoring and reprogramming. The
immune monitoring technology is designed to provide a personalized
comprehensive profile of the immune system. The immune
reprogramming technology is currently at the pre-clinical stage and
is designed to retrain the immune system to induce tolerance with
an objective of addressing rejection of transplanted organs,
autoimmune diseases, and allergies. For more information, please
visit www.aditxt.com.
Forward-Looking StatementsCertain statements in
this press release constitute “forward-looking statements” within
the meaning of the 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 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 entitled “Risk Factors” in the Company’s
prospectus, dated June 29, 2020, that was filed with the U.S.
Securities and Exchange Commission under File No. 333-235933, as
well as discussions of potential risks, uncertainties, and other
important factors in the Company’s subsequent filings with the U.S.
Securities and Exchange Commission. All such statements speak only
as of the date made, and 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.
Contacts
Investor Relations:PCG Advisory:
Jeff RamsonChief Executive Officer646-762-4518IR@aditxt.com
www.aditxt.com |
Media Relations:Stanford Blood CenterRoss
CoylePublic Relations
Officer650-421-1993rcoyle@stanford.edustanfordbloodcenter.org |
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