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.
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: