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Co-Diagnostics' detection of infectious disease has led it to join the coronavirus fight with flagship test

Snapshot

The Utah company's in-vitro Logix Smart Coronavirus Disease 2019 (COVID-19) test kits are available in nearly 50 countries

Co-Diagnostics - Co-Diagnostics joins fight against coronavirus with diagnostic test

Quick facts: Co-Diagnostics

Price: 25.73 USD

NASDAQ:CODX
Market: NASDAQ
Market Cap: $706.47 m
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  • Develops products to detect infectious diseases in humans and animals
  • Offers Logix Smart Coronavirus Disease 2019 detection test in US and globally
  • Has $24 million cash position to fund operations for next three years

What Co-Diagnostics does: 

Co-Diagnostics Inc (NASDAQ:CODX) is a molecular diagnostics company that develops products to detect infectious diseases in humans and animals. The company also develops tools for liquid-biopsy cancer screening and agricultural uses.

The Utah-based company, which also operates a second location at the CoSara Clinical Laboratories (CSCL) in Gujarat, India, offers medical labs and facilities a proprietary platform for the development of molecular diagnostic tests. It also manufactures state-of-the-art diagnostics technology. 

Co-Diagnostics' technology is utilized for tests designed for the detection and/or analysis of nucleic acid molecules (DNA or RNA). The company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and licenses the use of those tests to specific customers.

The company's main product is its Logix Smart test that runs a foundation of its trademark CoPrimer technology and CoDx software. The company offers four tests to detect tuberculosis and viruses -- Zika, Dengue, Chikungunya, and most importantly -- the SARS-CoV-2 virus, which causes the coronavirus (COVID-19) disease.

Co-Diagnostics also offers a host of mosquito abatement tests in the eastern US as well as the Midwest. The tests can be tailored to all regions of the country, including multiplexed tests that include either eastern equine encephalitis or western equine encephalitis. 

How is it doing:

Like many diagnostic and pharmaceutical companies, Co-Diagnostics is marshaling most of its resources to help medical professionals, regulatory officials and governmental bodies combat and stabilize the coronavirus pandemic through testing, therapies and treatments. 

The company is providing for sale its in-vitro Logix Smart Coronavirus Disease 2019 (COVID-19) test kits to nearly 50 countries and in the US to more than a dozen states. It most recently won approvals from both the Indian and Mexican governments to market and sell the test.

In February, the company was the first from the US to earn a coveted CE mark from European regulators. A month later the diagnostic test won Emergency Use Authorization (EUA) from the US Food and Drug Administration.

The test, which is currently available to all certified clinical laboratories, uses the company’s patented CoPrime technology to detect the presence of RNA in SARS-CoV-2, the virus that causes the COVID-19. 

The test is designed to run on a variety of commercially available platforms, with easy-to-interpret results in under two hours. The test has been found to offer 100% specificity and 100% sensitivity in several independent evaluations.

The company has orders from public and private organizations in nearly 50 countries and over 15 US states -- and demand has been strong and growing steadily for the test after winning FDA approval in early April.

Co-Diagnostics has manufactured more than six million tests to date and has ordered components for more than 20 million additional tests to fill existing and expected orders in the near future.

In its current second quarter, which ends June 30, 2020, Co-Diagnostics has seen sales of over $18 million year-to-date, with $16.5 million so far in the 2Q ( as of May 15). Management said the company is now profitable.  

In addition to the test, the company is moving ahead with a feasibility study aimed at developing a possible second COVID-19 test using CoPrimers to simultaneously identify both the virus and the antibody associated with a past infection in a single test. 

 

It also has developed, for Research Use Only (RUO), the Logix Smart 2019-nCoV kit, which is currently under verification and validation studies involving upper and lower respiratory tract and serum specimens. The company is also in discussion with regulatory officials in the US and the EU as well as the World Health Organization to secure emergency use authorization for that research test.

And Co-Diagnostics also announced it is developing a multiplex panel to differentiate between the COVID-19 virus and other upper respiratory pathogens in anticipation of future testing needs.

As it goes forward, debt-free Co-Diagnostics has managed to create a pro-forma cash position of $24 million that it says is sufficient to fund operations for the next three years.

In the meantime, news of the company’s coronavirus test and its sales successes have given its stock a major boost. Before the pandemic broke in early 2020, Co-Diagnostics' stock exchanged hands at around $1 a share but now trades around $28 a share, inflating its market cap to more $800 million.   

Inflection points:

  • Boost availability of Logix Smart Coronavirus Disease 2019 test kits
  • Move forward on developing a second COVID-19 test
  • Report audited profit in June quarter
  • Seek regulatory clearance for Logix Smart 2019-nCoV detection kit for ROU

What the boss says:

“There are several challenges to developing a test for a virus so relatively new on the world stage, especially one with many closely related genetic cousins such as SARS and MERS,” according to Co-Diagnostics CEO Dwight Egan.

“One of the most important advantages of our CoPrimer platform is its ability to reliably and accurately differentiate between similar genetic sequences, in order to reduce the likelihood of a false-positive diagnosis.”

What the broker says:

The Maxim Group in early August repeated a Buy rating on the stock with a price target of $30 a share -- which is close to the company’s most recent stock price. 

Analysts noted that Co-Diagnostics’ partner Clinical Reference Laboratory, one of the largest testing providers in the country, announced that it had received Emergency Use Authorization from the FDA for a self-collected, saliva-based PCR test for COVID-19. The test uses Co-Diagnostics probes and primers. 

“The test has demonstrated 100% sensitivity/specificity (higher than any other saliva-based molecular test for COVID-19) and can be processed within 24-48 hours, which is important considering that current tests are taking up to a week or more to return results,” they wrote. 

“With COVID cases on the rise in the US and testing times increasing past the point of usefulness, interest in expanding testing capacity has increased markedly.” 

Litchfield Hills Research and HC Wainwright & Co also have Buy ratings on the stock with price targets of $36 and $35, respectively.

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Co-Diagnostics to reach wider audience with FDA Emergency Use Authorization...

Co-Diagnostics Inc (NASDAQ:CODX) CEO Dwight Egan tells Proactive the molecular diagnostics company's Logix Smart coronavirus test has obtained Emergency Use Authorization from the FDA to be used to diagnose SARS-CoV-2. Egan says the authorization confirms the quality and performance of the...

on 04/07/2020

6 min read