Co-Diagnostics Completes Submission of CE Marking Registration for COVID-19 Coronavirus Test
February 20 2020 - 2:33PM
Business Wire
Company’s new Logix Smart™ COVID-19 Test
expected to be available with CE marking in February 2020
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™ COVID-19 Test technical file has been submitted for
registration with the European Community, and that it is expected
to be available later this month as an in vitro diagnostic (“IVD”)
for markets that accept a CE marking as valid regulatory
approval.
Dwight Egan, CEO of Co-Diagnostics, commented, “We are pleased
to announce this milestone, which comes after weeks of hard work by
our team at Co-Diagnostics to develop a high-performance diagnostic
to help prevent the spread of the new strain of coronavirus. Our
patented CoPrimer™ molecules have unique properties that lead to a
significant reduction in false positive test results over other
polymerase chain reaction (PCR) technologies, but will also allow
for enhanced multiplexing, or identifying multiple targets at once,
as we iterate the test to include other strains of coronavirus and
mutations of COVID-19.”
Co-Diagnostics’ Logix Smart COVID-19 Test uses the Company’s
CoPrimer technology to detect the presence of ribonucleic acid
(RNA) of the novel strain of coronavirus in a real-time RT-PCR kit
that targets conserved regions in the virus genome. The virus was
first identified in the Chinese city of Wuhan on January 7, before
spreading to 25 more countries, infecting over 75,000 people, and
causing nearly 2,130 deaths according to current data available on
Johns Hopkins Center for Systems Science and Engineering. A
representative for the US Centers for Disease Control and
Prevention (CDC) said last week that in addition to the testing
kits distributed by the CDC, it was critical for the private sector
to develop diagnostics for COVID-19 that could be commercially
scaled.
Mr. Egan continued, “The impact that this virus will have on the
global economy and health of countless individuals continues to
evolve. Co-Diagnostics is in the vanguard of commercializing
diagnostics to help ameliorate the effects of COVID-19 by ensuring
accurate diagnoses, and we are confident in our ability to scale to
meet demand as necessary.”
The technical file dossier submitted to the Company’s authorized
European representative includes a description of the test to
support conformance to the CE marking standards, which will confirm
that the test meets the Essential Requirements of the European
Community’s In-Vitro Diagnostic Medical Device Directive (IVDD
98/79/EC). The registration process is expected to be complete
later this month, at which point sales of the product may commence
as a CE-marked IVD. Co-Diagnostics will manufacture its Logix Smart
COVID-19 Test in the Company’s ISO 13485:2016 certified facility
for the development and manufacture of IVD Medical Devices located
in Utah, USA.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200220005835/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
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