The global shortage of COVID-19 testing kits is hitting the United States and other nations hard, but a recent FDA policy change means that Co-Diagnostics (NASDAQ:CODX) can help meet this unprecedented demand by aggressively distributing its COVID-19 test without prior FDA clearance - no longer just globally, but also to address the anxious and growing U.S. market.  Following a successful clinical evaluation showing 100% sensitivity and 100% specificity, the company plans to rapidly begin fulfilling orders from a multitude of U.S. customers, including thousands of additional laboratories that can now run the company’s test as a clinical diagnostic.

Accordingly, HC Wainwright has reiterated their Buy rating and $20 price target.

On March 18 they observantly note that:

…Co-Diagnostics has validated its Logix Smart COVID-19 test and submitted an EUA application to the FDA. We are aware that EUAs have thus far been issued to tests developed by Roche, Thermo Fisher, Hologic, LabCorp, Quest Diagnostics and Quidel, with the last two EUAs issued late yesterday. It seems the FDA continues to issue EUAs even though EUA is no longer required under the new guidance.

It should be clarified that where the Co-Diagnostics test differs from others is on how fast it works. While Roche pledges to have results identifying a Covid-19 infection in 3-1/2 hours. Becton Dickinson (BDX:NYSE), says its test is complete in two to three hours. According to their most recent release, Co-Diagnostics aims to do better: under 2 hours.

HC Wainwright continue:

The company plans to market its Logix Smart™ COVID-19 test to a wide array of U.S. laboratories without first requiring Emergency Use Authorization (EUA) from the FDA. We note that Co-Diagnostics has already been shipping its COVID-19 test to countries across five continents and scaling up production to meet global demand. These countries include Italy, Germany, UK, Turkey, Greece, the Philippines, Thailand, Australia, Paraguay, Ecuador, Israel, South Africa, Canada, and the U.S. In our view, the company is now able to serve the urgent need for rapid, accurate COVID-19 testing in the U.S., which has been lagging other developed countries on the testing front; the volume of tests shipped to domestic labs should ramp up in the immediate term.

Other highlights include:  

COVID-19 test kits to be sold in India. The company’s joint venture in India, CoSara Diagnostics, has become the first and only Indian company to receive a license from the Central Drugs Standards Control Organization (CDSCO) to manufacture reverse transcription polymerase chain reaction (RT-PCR) test kits for COVID-19... Test kits manufactured by CoSara are expected to be sold in the Indian market, targeting 52 government-approved testing facilities as well as 60 accredited private labs. CoSara’s COVID-19 test kits may also be exported to surrounding countries and regions. We note that COVID-19 testing in India has been inadequate, and the government plans to ramp up testing going forward. Therefore, we expect CoSara to ship increasing numbers of test kits in the coming weeks and months, which should make positive contributions to Co-Diagnostics’ bottom-line.

The full reports can be accessed here and here.

Disclosure: Co-Diagnostics Inc is a client of BDA International.

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Disclaimer

The information, opinions and analysis contained herein are based on sources believed to be reliable, but no representation, expressed or implied, is made as to its accuracy, completeness or correctness. The opinions contained in this analysis reflect our current judgment and are subject to change without notice. We do not accept any responsibility or liability for any losses, damages or costs arising from an investor’s or other person’s reliance on or use of this analysis. This analysis is for information purposes only, and is neither a solicitation to buy nor an offer to sell securities, nor a recommendation of any security, although members of the BDA may at times hold a position in the company covered within the article. Co-Diagnostics is a client of BDA International. Past gains are not a representative of future gains. The opinions herein contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning manufacturing, marketing, growth, and expansion. When used herein, the words “anticipate,” “intend,” “estimate,” “believe,” “expect,” “plans,” “should,” “potential,” “forecast,” and variations of such words and similar expressions are intended to identify forward-looking statements. Such forward-looking information involves important risks and uncertainties that could affect actual results and cause them to differ materially from expectations expressed herein. A company’s actual results could differ materially from those described in any forward-looking statements contained herein. BDA is not a licensed broker, broker dealer, market maker, investment advisor, analyst or underwriter. We recommend that you use the information found herein as an initial starting point for conducting your own research in order to determine your own personal opinion of the companies discussed herein before deciding whether or not to invest. You should seek such investment, tax, financial, accounting or legal advice appropriate for your particular circumstances. Information about many publicly traded companies and other investor resources can be found at www.sec.gov. Investing in securities is speculative and carries risk.

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