Following US Health and Human Services Secretary Alex Azar declaring a US public health emergency on the potential threat that the novel coronavirus poses, and the FDA determining that circumstances exist justifying Emergency Use Authorization (EUA) of in vitro diagnostics for detection and/or diagnosis of the COVID-19 outbreak, innovative companies such as Co-Diagnostics Inc (NASDAQ:CODX) have been amongst the first to announce their intention to submit detection kits tests to the FDA for EUA approval.

Rapid detection of COVID-19 cases in the U.S. requires wide availability of accurate diagnostic testing to control the emergence of a rapidly spreading, severe illness. More than any recent epidemic, this coronavirus poses new global challenges. As part of its recently announced $8.3 billion push for vaccines, treatments, and protective equipment, there are suggestions that the U.S. government needs to make the availability of a fast and accessible diagnostic kit a high priority so communities can quickly detect and contain the disease. 

Vice President Mike Pence, who is leading the Administration's response to the outbreak, acknowledged yesterday that there was a shortfall in the number of testing kits required:  "We don't have enough tests today to meet what we anticipate will be the demand going forward."

A change in FDA policy allows certain laboratories that develop and validate COVID-19 test kits to begin to use them as diagnostics before the FDA has completed review of their EUA requests. The FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a determination that there is a public health emergency and a declaration that circumstances exist justifying the medical products’ emergency use.

As a result, entities like Co-Diagnostics can now sell reagents to these laboratories for use in their diagnostics test kits, and the company reports its domestic product shipments have been increasing. The growing number of people infected by the virus also sparked sales around the world with interest in Co-Diagnostics’ CE-IVD Logix Smart COVID-19 test kit.  

In addition to the numerous requests received from U.S. clinical laboratories for the company’s reagents, expected to be used according to the FDA’s new policy, Co-Diagnostics CEO, Dwight Egan announced that the company is advancing toward emergency use clearance as an in vitro diagnostic by the FDA.  This would allow direct sales of its test kits to any clinical customer within the U.S. for use as a diagnostic.

Coupled with increasing international demand, domestic FDA clearance could potentially open up the huge U.S market for the company, possibly also leading to a slice of that $8.3 billion pie.

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

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