Healthcare diagnostic solutions development company AXIM Biotechnologies has filed a provisional patent application with the U.S. Patent and Trademark Office on a new test designed to measure the neutralizing antibodies against fentanyl, a synthetic opioid responsible for the world’s leading cause of overdose.

Additionally, the company has filed for a license to handle the controlled substance with the Drug Enforcement Administration (DEA) as required for research.

Dangers of Fentanyl

Fentanyl is a powerful synthetic opioid that is 50 to 100 times stronger than morphine and has a strong addiction profile and associated overdose risk. Prevention of fentanyl addiction and overdose within the current healthcare landscape is difficult.  However, new research is being conducted on potential immunotherapies and vaccines that prevent fentanyl from breaching blood-brain barrier to preemptively circumvent its overdose effects. (1)

Recent research suggests that fentanyl neutralizing antibodies may prevent overdose deaths, but scientists will need to quantitatively measure a patient’s neutralizing antibodies through clinical studies and for relapse prevention from boosters, and such a test does not currently exist on the market.

As a result and leveraging its experience in diagnostics and working with neutralizing antibodies, AXIM is developing a rapid point-of-care diagnostic assay that will detect and measure levels of fentanyl neutralizing antibodies. This aims to enable therapeutic and vaccine scientists to expedite transition of their research from lab to clinic using AXIM’s new test given the test’s quick time to result at clinical settings.

AXIM’s ongoing discussions with various academic and research groups on potential collaboration on the new test signal broad enthusiasm among the scientific community for its development and commercialization, the company says

“This test is another example of the broad applications of AXIM’s diagnostic platform,” says John Huemoeller II, CEO of AXIM Biotechnologies. “We continue to be able to leverage our processes and scientific expertise in developing rapid diagnostic assays of commercial significance. As most know, the fentanyl crisis continues to plague the US as well as many other countries and scientists from a myriad of fields continue to research ways to combat the devastation this lethal drug is causing. The commercial applications of this test are far and wide and represent a massive opportunity for AXIM. Once we receive our DEA license, we plan to begin clinical studies on the assay immediately, with the hopes of commercialization in the second quarter of 2023.”

Fentanyl addiction and overdose has skyrocketed in recent years amid the widely covered “opioid crisis.” According to the CDC, over 150 people die every day in the US from overdoses related to synthetic opioids like fentanyl and the drug is the primary driver of overdose deaths in the United States.

For this reason, the U.S. and other government and regulatory bodies are incentivizing organizations through grants and licenses to conduct research on potential therapeutics or vaccines that may prevent overdose or addiction. AXIM plans to market its newly developed test to these research institutions as a leading way to measure neutralizing antibodies in clinical trial patients.