FDA Policy Change to Allow Rapid Domestic Expansion of Co-Diagnostics COVID-19 Test
March 17 2020 - 6:30AM
Business Wire
Co-Diagnostics, Inc. (Nasdaq:CODX), a molecular
diagnostics company with a unique, patented platform for the
development of diagnostic tests, announced today that a new FDA
policy released last night aimed at expediting the availability of
COVID-19 diagnostics will allow the Company to aggressively expand
its presence in the U.S. market.
Co-Diagnostics was the first U.S. company to obtain a CE marking
for a COVID-19 test, and international shipments have continued to
escalate. In the past month, the Company has shipped its CE marked
and research use Logix Smart™ COVID-19 test kits to countries all
over the world. These include Italy, Germany, the United Kingdom,
Turkey, Greece, the Philippines, Thailand, Australia, Paraguay,
Ecuador, Israel, South Africa, and Canada, in addition to numerous
shipments to customers and research institutions in the United
States.
Previous domestic shipments to date have been in accordance with
the FDA’s policy change on February 29, 2020 that allows U.S. CLIA
laboratories to use the Company’s COVID-19, under certain
conditions. Now, as a result of the change announced last night by
the FDA, the Company’s test kit will soon be available for use by
and marketed to a wide array of U.S. laboratories, without first
requiring Emergency Use Authorization.
Co-Diagnostics CEO Dwight Egan remarked, “The ramifications of
this new FDA policy are significant for our Company. This change
will quickly afford Co-Diagnostics even more opportunities to serve
the needs of laboratories nationwide, as we play an even larger
role in responding to this pandemic. We applaud the FDA’s decision
to recognize the dire need for increased access to high-quality
COVID-19 tests, and to adapt as the situation demands in light of a
public health emergency.
“With no known treatment or approved vaccine for the
highly-infectious COVID-19, the need for accurate and rapid
diagnoses has never been greater. Our cost-effective Logix Smart
CODIV-19 test has been designed to run on a variety of commercially
available platforms, with easy-to-interpret results in under two
hours. We are confident in our ability to meet the growing demand
for this diagnostic.”
See the original press release from the Food and Drug
Administration here.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular
diagnostics company that develops, manufactures and markets a new,
state-of-the-art diagnostics technology. The Company’s technology
is utilized for tests that are designed using the detection and/or
analysis of nucleic acid molecules (DNA or RNA). The Company also
uses its proprietary technology to design specific tests to locate
genetic markers for use in industries other than infectious disease
and license the use of those tests to specific customers.
Forward-Looking Statements:
This press release contains forward-looking statements.
Forward-looking statements can be identified by words such as
"believes," "expects," "estimates," "intends," "may," "plans,"
"will" and similar expressions, or the negative of these words.
Such forward-looking statements are based on facts and conditions
as they exist at the time such statements are made and predictions
as to future facts and conditions. Forward-looking statements in
this release may include statements regarding the (i) use of
funding proceeds, (ii) expansion of product distribution, (iii)
acceleration of initiatives in certain verticals or markets, (iv)
capital resources and runway needed to advance the Company’s
products and markets, (v) increased sales in the near-term, (vi)
flexibility in managing the Company’s balance sheet, (vii)
anticipation of business expansion, and (viii) benefits in research
and worldwide accessibility of the CoPrimer technology and its
cost-saving and scientific advantages. Forward-looking statements
are subject to inherent uncertainties, risks and changes in
circumstances. Actual results may differ materially from those
contemplated or anticipated by such forward-looking statements.
Readers of this press release are cautioned not to place undue
reliance on any forward-looking statements. The Company does not
undertake any obligation to update any forward-looking statement
relating to matters discussed in this press release, except as may
be required by applicable securities laws.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200317005264/en/
Company Contact: Andrew Benson Head of Investor Relations
+1 801-438-1036 investors@codiagnostics.com
Media Contact: Jennifer Webb Coltrin & Associates,
Inc +1 267-912-1173 jennifer_webb@coltrin.com
Co Diagnostics (NASDAQ:CODX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Co Diagnostics (NASDAQ:CODX)
Historical Stock Chart
From Sep 2023 to Sep 2024