Co-Diagnostics Creates Sales Opportunities with CE Mark Submission and Mosquito Testing Vertical

NEW YORK, NY / ACCESSWIRE / February 28, 2019 / Utah-based Co-Diagnostics, Inc., (NASDAQ: CODX), has hit the ground running this year. The last week alone has brought news of expanding their revenue potential in the vector control vertical, a CE mark submission for a high-quality diagnostic with a global market that tests for multiple diseases at once, and the announcement that they are out of the woods as far as their Nasdaq listing requirements.

Vector control – or mitigating organisms that transmit infectious diseases, in this case mosquitos – is an important component of slowing the spread of mosquito-borne pathogens.

Often overlooked in this space is the fact that a test used for mosquito abatement by definition is not testing human samples, and therefore is not bound by the strict regulatory requirements governing the use of in vitro diagnostics (IVDs). This basically means that Co-Diagnostics can begin selling in-demand tests currently being developed in advance of regulatory approval, including to testing centers throughout the United States without first obtaining a 510(k) or Premarket Authorization (PMA) approval from the FDA. This potentially represents an exciting revenue opportunity for the company.

Revenue prospects are further bolstered by the more recent announcement of the CE marking submission for their Zika, Dengue, Chikungunya multiplex diagnostic, for use as an IVD in areas that accept a CE mark as valid regulatory approval. More than 50% of the world’s population live in areas at risk to one or all of these diseases, which all have similar symptoms and have been notoriously misdiagnosed as a result.

However, because of those misdiagnoses, and because prompt and appropriate treatment is only effective if the diagnosis is correct and fast to begin with, physicians in affected areas prefer a diagnostic tool that is not only affordable, but specific enough to accurately differentiate between all three diseases and avoid false positives.

According to Dwight Egan, CEO of Co-Diagnostics, that is exactly where their Logix Smart ZDC test excels:

”Enhanced specificity – or discriminating between similar genetic sequences to avoid false positive diagnoses – is one of the most valuable characteristics of the CoPrimer technology, especially in multiplexed assays. Our ZDC multiplex test provides patients and health care providers a low-cost solution to test for all three viruses at once, with the confidence that the test results will aid in determining the most suitable treatment for each patient. Early and accurate detection of severe dengue, for example, can lower the mortality rate to below 1% from as high as 50% when left untreated or treated improperly.”

The global market for a ZDC diagnostics, the potential for accelerated domestic and overseas revenue from their vector control vertical, and their recent announcement that they have regained Nasdaq Capital Markets listing requirements according to Rule 5550(b)(1) should all help to put shareholders’ minds at ease when contemplating this company’s future.

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SOURCE: Co-Diagnostics, Inc.

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