Co-Diagnostics (NASDAQ:CODX) Ready to Meet U.S Vice President’s Plea for More Domestic Tests
March 06 2020 - 1:01PM
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
Co Diagnostics (NASDAQ:CODX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Co Diagnostics (NASDAQ:CODX)
Historical Stock Chart
From Apr 2023 to Apr 2024