Aditxt Secures CLIA Certification for AditxtScore™ Laboratory Operations in Richmond, VA, and Plans to Launch AditxtScore™ for COVID-19 as a Lab Developed Test (LDT)
Upcoming Vaccines Increase the Need for Ongoing Monitoring of Presence and Durability of Immunity
Mountain View, CA , Nov. 19, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- Aditx Therapeutics, Inc. (Aditxt) (the “Company”) (Nasdaq: ADTX), a life sciences company developing biotechnologies specifically focused on improving the health of the immune system through immune monitoring and reprogramming, today announced that its AditxtScore™laboratory operations for immune monitoring has secured CLIA certification, allowing for the launch of AditxtScore™for COVID-19 as a Laboratory Developed Test (LDT).
AditxtScore’s™ operations will initially be co-located at the facilities of Salveo Diagnostics, Inc., the Company’s collaboration partner, located in Richmond, VA. This will expedite the commercial launch of AditxtScore™ for COVID-19, which is targeted for January 2021. These Company-managed AditxtScore™operations will provide Aditxt with the necessary flexibility, stringent quality control and rapid deployment needed for these sensitive products.
In parallel, Aditxt plans to continue to pursue the EUA application it submitted to the Food and Drug Administration in late August 2020 for AditxtScore™for COVID-19, which is expected to provide a path to 510(k) clearance as well.
Amro Albana, Co-Founder and CEO of Aditxt, commented, “As we prepare to roll out the AditxtScore™ immune monitoring platform and applications, the establishment of our own CLIA-certified AditxtScore™ operation is vital to realizing our full vision, which is to transform immune diagnosis from reactive testing to proactive monitoring. We believe that the upcoming availability of two new vaccines, as was recently announced, will increase the need for ongoing monitoring of the immune system in order to assess the presence and durability of immunity at any point in time.”
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