New York City, March 06, 2020 (GLOBE NEWSWIRE) — 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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