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AXIM Biotechnologies Inc (OTCMKTS: AXIM) Engages its Manufacturing Partner, Empowered Diagnostics, to File Amended Emergency Use Authorization with FDA for ImmunoPass



Dry Eye Disease (DED) affects more than 344 million people worldwide, and the number is growing in both young and old adults. Hence, clinicians have found it essential to figure the best means of diagnosing and treating the prevalence of this condition. And through its manufacturing partner Empowered Diagnostics, AXIM Biotechnologies Inc (OTCMKTS: AXIM) filed an amended emergency use authorization (EUA)for ImmunoPass. The rapid test detects COVID-19 neutralizing antibodies. 

Several conversations with the FDA and the submission of updated clinical trials, studies, and a robustness study on ImmunoPass culminated into the amendment. ImmunoPass is an ideal device because it is straightforward to use, according to John W. Huemoeller II, the CEO of AXIM® Biotech. It also produces accurate results within minutes. 

The Acquisition of DED Testing Technology by AXIM

leading experts in healthcare and biotechnology are behind the delivery of innovative diagnostics by Empowered Diagnostics. The Pompano Beach, Florida-based biotech is one of the US’s largest capacity manufacturers of rapid diagnostic solutions. Its mission is to empower and improve people’s lives through affordable and reliable tests. 

On the other hand, AXIM is determined to offer solutions to the changing diagnosis and treatment for oncology and SARS-CoV-2. It is also keen on developing rapid diagnostic tests for the early detection of DED. It has since signed a Binding Term Sheet to acquire the necessary technology, including two FDA authorizations. The definitive agreement, which closes later in the year, will also approve the commercial sale of two ophthalmic diagnostic lab tests. Meanwhile, AXIM is anticipating the commercial launch of the first product at the beginning of 2022.

The prevalence of Dry Eye Disease 

According to a study by the American Journal of Ophthalmology, there are more than six million DED cases that are yet to be diagnosed. The condition, which occurs when tears cannot provide enough lubrication for the eyes, impairs visual acuity and decreases the quality of life with age. The bad news is that it’s a multifactorial disease with many disparate causes, and there is frequently a discordance between signs and symptoms.

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