The company said 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: reveal levels of antibodies neutralizing COVID-19; and 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 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 changed course on the regulation of COVID-19 LDTs, allowing the FDA to require providers to submit EUA applications for such tests.
Aditxt develops technologies focused on improving immune system health through immune monitoring and reprogramming.
Perrigo's Omeprazole Magnesium Delayed-Release Mini Capsules receives US FDA final approval
Nanoscope Therapeutics names new advisors to company's Board and Management
Alcon to expand ophthalmic eye drop portfolio with acquisition of EYSUVIS
Third shot of Pfizer-BioNTech vaccine '80% effective' against Omicron in under-5s
STADA Arzneimittel's Kinpeygo receives positive EU regulator opinion for IgAN kidney disease
Astellas receives unfavourable decision in LEXISCAN(R) 0.4mg/mL US patent trial