Co-Diagnostics, Inc. Receives CE Mark for Novel Coronavirus Test
24 Febrero 2020 - 2:37PM
Business Wire
Logix Smart™ COVID-19 Test now available for
export from the United States as a CE-marked IVD
Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular
diagnostics company with a unique, patented platform for the
development of molecular diagnostic tests, announced today that its
Logix Smart™ Coronavirus COVID-19 Test has obtained regulatory
clearance to be sold as an in vitro diagnostic (“IVD”) for the
diagnosis of SARS-CoV-2 (COVID-19) in markets that accept
CE-marking as valid regulatory approval, and is now available for
purchase from the Company’s Utah-based ISO-13485:2016 certified
facility.
The Declaration of Conformity for the Logix Smart COVID-19 test
confirms that it meets the Essential Requirements of the European
Community’s In-Vitro Diagnostic Medical Device Directive (IVDD
98/79/EC), permitting export and sales of the product as an IVD to
commence immediately in the European Community. Co-Diagnostics
shipped samples of the Research Use Only version of its test to
distributors in Italy and Germany last week, which allows future
customers to confirm the quality and sensitivity of the product
prior to the IVD being available, and the Company to accelerate the
sales efforts of its diagnostic. Many other global markets also
accept a CE marking as valid regulatory approval following routine
local product registration, which allows sales of the Company’s IVD
into these areas.
Dwight Egan, Chief Executive Officer of Co-Diagnostics,
remarked, “Co-Diagnostics has received overwhelming interest in our
novel coronavirus diagnostic from all over the world since first
announcing its development a month ago. As the disease has spread
from China, so have concerns about the global health community’s
ability to contain and control it. The first step in containment is
a prompt, accurate diagnosis, and we are pleased to provide this
product to those areas that are able to utilize a CE-marked IVD to
protect their residents and visitors from a disease that has
already affected millions.
“We believe Co-Diagnostics is the first U.S. company to receive
a CE-marking for a coronavirus IVD, which is a testament to the
quality of our platform. The rapid development of our COVID-19 test
was made possible thanks to our proprietary design process and
patented CoPrimer™ technology platform. We look forward to scaling
up production to meet global demand with this regulatory clearance
in place, and to obtaining approvals from other bodies that will
allow us to further increase the reach of this invaluable
diagnostic tool.”
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 include statements regarding the (i) use of funding
proceeds, (ii) expansion of product distribution, (iii)
acceleration of initiatives in liquid biopsy and SNP detection,
(iv) use of the Company’s liquid biopsy tests by laboratories, (v)
capital resources and runway needed to advance the Company’s
products and markets, (vi) increased sales in the near-term, (vii)
flexibility in managing the Company’s balance sheet, (viii)
anticipation of business expansion, and (ix) 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200224005882/en/
Company Sales Contact: Seth Egan Head of International
Sales +1 801-438-1036 #2 s.egan@codiagnostics.com
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