AXIM Biotechnologies Applauds FDA's Recent COVID-19 Test Policies to Support Rapid Neutralizing Antibody Tests
SAN DIEGO, Nov. 18, 2021 (GLOBE NEWSWIRE) -- AXIM Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM® Biotech,” or “the Company”), an international healthcare solutions company targeting oncological, COVID-19 and Dry Eye Disease (DED) diagnostics, today applauds the FDA on its recent update to its COVID-19 test policies that aims to increase nationwide access to at-home and point-of-care tests as well as ensure the accuracy and reliability of such diagnostic tests.
As part of the agency’s mission to support increased access to at-home and point-of-care COVID-19 testing efforts, the FDA has announced its focus on emergency use authorization (EUA) requests for various diagnostic tests for use with or without a prescription that can be manufactured in high volumes. This includes lab-based and point-of-care high-volume antibody tests that can measure the amount of antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies. This further supports AXIM’s development of its Rapid Neutralizing Antibody Test for COVID-19.
“For the first time ever, the agency is publicly prioritizing the review and approval of neutralizing antibody tests,” said John W. Huemoeller II, AXIM® Biotech Chief Executive Officer. “Only a specific subset of antibodies are able to neutralize the COVID-19 virus. Measuring the levels of neutralizing antibodies determines if a person has the specific antibodies that deactivate the virus and are associated with adaptive immune response. This is excellent news for AXIM as we made it a priority early on in the pandemic to develop a test to measure neutralizing antibody levels.”
Currently, AXIM has developed three different types of neutralizing antibody tests including:
AXIM recently announced the publication of an article on the development of its test in the Journal of Clinical Virology, which was conducted by Dr. Douglas Lake, an associate professor at Arizona State University. The article outlind how the test can be performed in a point-of-care setting or by an individual and has demonstrated over 90% sensitivity and 100% specificity when benchmarked against an authentic SARS-CoV-2 neutralization assay using serum samples from COVID-19 patients. Additionally, AXIM’s manufacturing partner Empowered Diagnostics has filed for Emergency Use Authorization for the point-of-care qualitative test, which is pending final review and approval in Canada and the EU.
About AXIM® Biotechnologies
Welcome Reception - For Paid Conference Pass Holders, Exhibitors, Sponsors, Speakers, Press
Interoperability Between Digital Assets and Local Currencies
Keynote Panel Session - Open to all Badge Holders