Co-Diagnostics Awarded CE Mark for Tuberculosis Test Kit

Co-Diagnostics (NASDAQ:CODX) announced a milestone achievement on Wednesday (July 25) with the European Union (EU) granting the company CE mark approval for its tuberculosis test kit, Logix Smart MTB Test.

The company’s press release states the device can identify DNA of mycobacteria tuberculous (MTB) complex members and works through real-time polymerase chain reaction (PCR) to uncover the IS6110 and MPB64 areas of the MTB genome.

Receiving the CE mark approval will allow the test to be sold as an in vitro diagnostics for pinpointing tuberculosis within the EU and areas that accept a CE-IVD mark as a legitimate regulatory approval.

Dwight Egan, CEO of Co-Diagnostics said in the press release that while the CE mark is significant for the company, it is just as important for people in need of affordable tuberculosis testing.

“Our proprietary design platform and CoPrimer™ technology, on which this test was built, are now also being used to design tests for HIV and multi-drug resistant tuberculosis (“MDR-TB”),” Egan added.

Co-Diagnostics says the device will be built at its IVD medical device facility in Utah, but isn’t seeking US Food and Drug Administration (FDA) approval to market the device in the US due to low tuberculosis incidents in the country.

In its press release on July 17 advising of its submission for the device’s CE mark approval, the company said Logix Smart has a projected availability purchase date as early as August in the EU.

“This newest iteration of our MTB screening test has been tailored to target detection of the two genes present in a broad range of tuberculosis infections, to greatly mitigate the potential of false negatives and improve the diagnosis and prognosis of patients afflicted with this disease worldwide,” Egan said in the July 17 press release.

According to the European Centre for Disease Prevention and Control, nearly 59,000 cases of tuberculosis were reported in 2016 across 30 EU/EEA countries.  Tuberculosis is caused by bacteria that most affects the lungs, and is spread from person-to-person through the air.  The disease, however, is curable and preventable, but is still deadly.

Case in point, the World Health Organization (WHO) in its most recent fact sheet on tuberculosis  states that the disease is one of the top 10 causes of death around the world, with 10.4 million in total contracting the virus in 2016 and 1.7 million succumbing to the disease. In the EU, WHO has a target elimination date of tuberculosis of 2050 in European low-incidence countries.

“The key component to battling tuberculosis is an early, accurate, and affordable diagnosis. We are confident that the time we have taken to ensure this test meets our high standards of quality and performance,” Egan said on July 17. “The Departments or Ministries of Health recognize clearance by the European Community as valid regulatory approval to allow sale of CE marked products throughout their jurisdictions.”

Following Wednesday’s announcement, shares of Co-Diagnostics responded favorably with a 4.75 bump to reach US$3.53 as of 2:48 p.m. EST.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.