AXIM® Biotechnologies Files Emergency Use Authorization With the FDA for First-in-Class COVID-19 Rapid Diagnostic Test for Neutralizing Antibodies
SAN DIEGO, Sept. 16, 2020 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM® Biotech,” “AXIM” or “the Company”), an international healthcare solutions company targeting oncological and COVID-19 research, announced today it has filed an Emergency Use Authorization (EUA) application with the Food and Drug Administration (FDA) for measuring COVID-19 neutralizing antibodies in plasma and serum through its first-in-class rapid diagnostic test.
AXIM’s rapid diagnostic test is expected to be the market’s first COVID-19 rapid diagnostic test for measuring levels of functional neutralizing antibodies in a lateral flow assay format. Neutralizing antibodies prevent SARS-CoV-2, the virus responsible for the current COVID-19 pandemic, from binding to and entering host cells.
Last month, AXIM signed an exclusive limited licensing, manufacturing and distribution agreement with Empowered Diagnostics LLC (“Empowered Diagnostics”) for high volume production of the Company’s rapid diagnostic test. Under this agreement, Empowered Diagnostics will manufacture the lateral flow assays under the name “Tru-19 Neutralizing Antibody Test” (“Tru-19”). With the filing of this EUA, the Company is now able to begin selling Tru-19 to clinics immediately.
Tru-19 is unlike other rapid serological COVID-19 tests currently on the market because it measures levels of neutralizing antibodies in serum or plasma from patients that have recovered from COVID-19. With this knowledge, plasma with the highest levels of neutralizing antibodies can be identified and administered to patients fighting COVID-19. Since the Tru-19 test agrees with virus-based assays, it could be a tool for monitoring levels of neutralizing antibodies in large numbers of vaccine recipients.
Tru-19 can also be used to measure levels of neutralizing antibodies in patients receiving hyperimmune globulin or convalescent plasma so that healthcare providers can decide on the proper dosing of neutralizing antibodies that correlates with favorable outcomes. In the future, AXIM intends to make Tru-19 available to large employer groups, essential workers, and others who would like to know their levels of protective neutralizing antibodies.
AXIM® Biotech CEO John . Huemoeller II commented: “Our ultimate goal is to get Tru-19 approved and manufactured as a point-of-care test as quickly possible. We are confident that once care providers see how easy to use Tru-19 is, it will become the go-to choice for assessing levels of immunity and protection against re-infection. All roads point to neutralizing antibodies as a key measurement in defeating COVID-19.”
Earlier this year, AXIM announced that Tru-19 accurately classified serum from patients who strongly neutralized SARS-CoV-2 and serum from patients who poorly neutralized the virus. Importantly, Tru-19 did not cross-react with serum from patients with seasonal respiratory infections including seasonal coronaviruses, suggesting that the test is highly specific for COVID-19.
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