MENU

Getting Started

NEW YORK

+1 646-679-4321

get directions

LONDON

+44 203-289-5319

get directions

OUR SERVICES

NEW YORK

+1 646-679-4321

get directions

LONDON

+44 203-289-5319

get directions

Co-Diagnostics (NASDAQ:CODX) Ready to Meet
U.S Vice President’s Plea for More Domestic Tests

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.

About BDA International, Inc.:

BDA International is an independent global Investor Relations firm offering a
wide range of IR-related analysis, research and advisory services. In
particular, we provide and are compensated for service packages that include
strategic action plans and investor/market perception studies to help entities
improve communication with customers and investors, and to increase their
visibility. BDA International has received no direct compensation related to
this release but its principles hold shares of client companies in our
personal portfolios, including CODX. BDA International accepts sole
responsibility for the content and distribution of the foregoing release,
which does not contain any previously unpublished or non-public information.
Parties interested in learning more about the relationship between BDA and
CODX may do so via the contact information at the bottom of this release.

Disclaimer

The information, opinions and analysis contained herein are based on sources
believed to be reliable, but no representation, expressed or implied, is made
as to its accuracy, completeness or correctness. The opinions contained in
this analysis reflect our current judgment and are subject to change without
notice. We do not accept any responsibility or liability for any losses,
damages or costs arising from an investor’s or other person’s reliance on or
use of this analysis. This analysis is for information purposes only, and is
neither a solicitation to buy nor an offer to sell securities, nor a
recommendation of any security, although members of the BDA may at times hold
a position in the company covered within the article. Co-Diagnostics is a
client of BDA International. Past gains are not a representative of future
gains. The opinions herein contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, including,
but not limited to, statements concerning manufacturing, marketing, growth,
and expansion. When used herein, the words “anticipate,” “intend,” “estimate,”
“believe,” “expect,” “plans,” “should,” “potential,” “forecast,” and
variations of such words and similar expressions are intended to identify
forward-looking statements. Such forward-looking information involves
important risks and uncertainties that could affect actual results and cause
them to differ materially from expectations expressed herein. A company’s
actual results could differ materially from those described in any
forward-looking statements contained herein. BDA is not a licensed broker,
broker dealer, market maker, investment advisor, analyst or underwriter. We
recommend that you use the information found herein as an initial starting
point for conducting your own research in order to determine your own personal
opinion of the companies discussed herein before deciding whether or not to
invest. You should seek such investment, tax, financial, accounting or legal
advice appropriate for your particular circumstances. Information about many
publicly traded companies and other investor resources can be found at
www.sec.gov. Investing in securities is speculative and carries risk.

Investor Relations Contact:
Mushtaq Dost
BDA International
www.bda-ir.com
dost@bda-ir.com

06CONTACT

Ready for the next phase in your capital markets journey?

Contact Us
LOCATION 1

NEW YORK

375, 5th Avenue, Suite 1402,
New York, NY, 10016

+1 646-679-4321

LOCATION 2

LONDON

Level 33, 25 Canada Square,
Canary Wharf, London E14 5LB,

+44 203-289-5319