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AXIM Biotechnologies Applauds FDA's Recent COVID-19 Test Policies to Support Rapid Neutralizing Antibody Tests
AXIM Biotechnologies Applauds FDA's Recent COVID-19 Test Policies to Support Rapid Neutralizing Antibody Tests.
About this update from Axim Biotechnologies, Inc.
[{"type":"text","content":"\n 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: A qualitative test that measures levels of neutralizing antibodies using a reader;A semi-quantitative test that provides three measures of neutralizing antibody levels -- low, medium and high;And a qualitative test that provides yes/no results indicating whether the number of neutralizing antibodies is likely to provide immunity from contracting the virus have been detected. 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 a...