Aditxt Introduces AditxtScore™ for COVID-19 and Announces the Completion of Validation Studies by Stanford Blood Center
Aditxt Therapeutics, Inc. (Nasdaq: ADTX) has announced plans to file for Emergency Use Authorization (EUA) and a 510(k) application for its AditxtScore™ for COVID-19, a multiplex assay for detecting SARS-CoV-2 antibodies. Validated by Stanford Blood Center, this platform distinguishes various antibody isotypes (IgG, IgM, IgA) simultaneously, enhancing detection sensitivity. Aditxt aims for regulatory submissions by Q3 2020 and anticipates launching pilot programs in Q4 2020 and commercial availability in Q1 2021. The AditxtScore™ may also be used for evaluating immune responses to vaccines.
- AditxtScore™ for COVID-19 validated by Stanford Blood Center.
- Dual multiplex assay enhances antibody detection sensitivity and specificity.
- Plans for EUA and 510(k) applications demonstrate proactive regulatory approach.
- Potential applications for monitoring responses to vaccines and other diseases.
- None.
Company Plans to file for an Emergency Use Authorization (EUA) and 510(k) Application in the Current Quarter (Q3, 2020)
Loma Linda, CA, Aug. 06, 2020 (GLOBE NEWSWIRE) -- 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 Center
Stanford 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 Therapeutics
Aditxt 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 Statements
Certain 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 Ramson Chief Executive Officer 646-762-4518 IR@aditxt.com www.aditxt.com | Media Relations: Stanford Blood Center Ross Coyle Public Relations Officer 650-421-1993 rcoyle@stanford.edu stanfordbloodcenter.org |
FAQ
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