On March 20, 2020, Co-Diagnostics, Inc. (Nasdaq:CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that following a successful clinical evaluation of its Logix Smart™ COVID-19 Test, the Company will begin fulfilling orders from a wider array of U.S. customers, including thousands of additional laboratories in the country who can now run the Company’s test as a clinical diagnostic.
A recent FDA policy change aimed at expediting the availability of COVID-19 diagnostics has allowed the Company to expand domestic sales of its test immediately. Co-Diagnostics’ COVID-19 polymerase chain reaction (PCR) test can yield results in under two hours, and successfully passed the clinical evaluation as requested in the policy change, showing sensitivity of 100% and specificity of 100% in detecting SARS-CoV-2, the virus which causes COVID-19, without demonstrating any cross-reactivity with other coronaviruses.
Dwight Egan, Co-Diagnostics CEO, commented, “Our Logix Smart COVID-19 test has already been deployed on a global basis to five continents as well as to U.S. CLIA labs that meet certain requirements, and we are prepared to provide an even greater number of U.S. laboratories and patients access to our test as a result of the new FDA policy. The demand for reliable, high-quality COVID-19 diagnostics has never been greater, and it continues to grow daily as this disease affects not just patients afflicted with it and their families, but the entire nation as a whole.
“We believe the excellent performance of our COVID-19 test combined with affordable pricing will place it in the vanguard of available testing alternatives worldwide. We have scaled up both our domestic and international production capabilities to meet demand, including receiving a license to manufacture our COVID-19 test in our facility in India, which more than triples our capacity. The Company’s Logix Smart COVID-19 test, built on our patented CoPrimer™ technology, has the potential to improve the quality of life of millions of Americans by providing access to a prompt, accurate, cost-effective test. We are gratified to be in a position to make available a test that can provide results in less than two hours, which we believe is among the fastest turn-around times of any test currently on the market.”
The new FDA policy permits Co-Diagnostics to begin U.S. sales of COVID-19 tests immediately while it awaits FDA clearance under Emergency Use Authorization (EUA). The Company’s application for EUA is currently under review by the FDA.
On March 19, 2020, Co-Diagnostics announced that CoSara Diagnostics Pvt Ltd (“CoSara,” or the “JV”), its joint venture for manufacturing in India, has become the first and only Indian company to receive a license from the Central Drugs Standards Control Organisation (CDSCO) to manufacture RT-PCR COVID-19 test kits. The kits are expected to be sold in the Indian market, as well as for export to the surrounding regions.
CoSara has aligned itself with the “Make in India” initiative introduced in 2014 to transform India into a global design and manufacturing hub, and senior officials from the health department expedited the approval process for the license. The country took early measures to recall its citizens, drastically limit travel into the country and eventually close the country’s borders, which has also increased the demand for indigenous COVID-19 tests to serve India’s population of 1.3 billion.
The outbreak has been declared an epidemic in several states where provisions of the Epidemic Diseases Act have been invoked, and educational institutions and many commercial establishments have been shut down. Prime Minister Narendra Modi also recently called for enhanced testing facilities in an effort to contain the spread of the disease in a country where social isolation, as practiced in other areas, may prove difficult due to the high population density. According to economists, if the pandemic in India grows out-of-control, the consequences are likely to be even more severe than in Italy.
The COVID-19 test kits approved by the CDSCO were those originally designed by Co-Diagnostics, the first U.S. company to receive a CE marking for a COVID-19 diagnostic. “The high-quality tests built on our patented CoPrimer™ technology will have a positive impact on what is projected to be the largest healthcare market in the world,” said Dwight Egan, CEO of Co-Diagnostics. “Co-Diagnostics is honored that our joint venture has achieved such a significant milestone.”
Mohal Sarabhai, Director of CoSara, remarked “Presently there are 52 government-approved testing facilities and delivering the kits to those is the first target,” in addition to pursuing 60 accredited private labs to conduct COVID-19 tests. “Overall, our target market will be private as well as government labs.”
The large players volume has formed a positive divergence to the price of CODX stock. The Twiggs Money Flow has gone negative which is bearish.
The real danger of this stock is that the FDA seems to not be too fond of Co-Diagnostics test. That might be because of the failure of the CDC and the tests that were sent to States. It could be a case of an over abundance of caution after the previous testing snafu by the CDC.
It feels like the FDA is approving other tests quickly and the Co-Diagnostics test is like, well, if we have to we’ll approve it but we’d rather approve these better tests first. Again, this is just what it sort of feels like at the present. That may not be true as we don’t really know why it has taken Co-Diagnostics’ test this long to get a thumbs up from the FDA while other company’s have already gotten their tests approved. We could see CODX stock soar in the coming days if their test finally gets approved.