Co-Diagnostics, Inc. Receives CE Mark for Zika Screening Test
October 18 2018 - 6:30AM
Business Wire
Company’s Logix Smart™ Zika Test to be
available for purchase with CE mark
Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular
diagnostics company with a unique, proprietary platform for the
development of molecular diagnostic tests, announced today that its
Logix Smart™ Zika Test technical file has obtained CE mark
approval, the principle regulatory clearance allowing the test to
be sold as an in vitro diagnostic (“IVD”) for the diagnosis of Zika
virus in European Union states and other markets that accept a
CE-IVD mark as valid regulatory approval.
Dwight Egan, Chief Executive Officer of Co-Diagnostics,
remarked, “The CE marking of the most recent iteration of our Zika
test is a significant step towards meeting demand for disease
detection products in one of our key target markets. Given the
ability of Zika infections to be passed along through mosquito
vectors as well as sexual transmission, the key component to
preventing the occurrence of these tragic developmental disorders
is an early, accurate, and affordable diagnosis for both men and
women. Like many mosquito-borne illnesses, Zika infections tend to
occur in cycles, but the World Health Organization (“WHO”) has
recently emphasized that the threat of Zika has not abated. We are
confident that this test meets our high standards of quality and
performance and will allow us to better meet the demand for
affordable Zika diagnostic options, the absence of which can have
awful consequences for families and create additional burdens on
social health programs.”
The CE mark confirms that the test meets the Essential
Requirements of the European Community’s In-Vitro Diagnostic
Medical Device Directive (IVDD 98/79/EC), allowing sales of the
product to commence as an IVD with the CE marking included. The
Logix Smart Zika Test uses polymerase chain reaction (“PCR”)
technology to detect the presence or absence of the Zika virus in
serum, plasma, collected alongside with urine, from patients
suspected to be infected. While not lethal itself, studies have
directly linked Zika with cases of microcephaly, a neurological
disease that affects the brain development of fetuses. The WHO has
raised the priority for R&D investments for Zika in their 2018
annual review of diseases.
Mr. Egan continued, “Co-Diagnostics’ patented CoPrimer™ design
platform, on which this test is built, has been shown to
drastically reduce the occurrence of ‘primer-dimers,’ the
often-occurring phenomenon that leads to false positives in PCR
diagnostics. The groundbreaking multiplexing capabilities of
CoPrimers is also being used to facilitate the development of
another diagnostic test to identify and distinguish between Zika,
dengue fever, and chikungunyua, three diseases with a high degree
of comorbidity in regions where they are prevalent. We have already
seen very promising verification results for this multiplexed
screening test and look forward to being able to announce news
related to its regulatory clearance in the near future, further
augmenting our Company’s molecular diagnostics product offerings in
underserved markets of the world.”
Co-Diagnostics will manufacture its Logix Smart Zika test in the
Company’s ISO 13485:2016 facility for development and manufacture
of IVD Medical Devices located in Utah, USA. At this time the
Company is not seeking approval by the FDA for sale in the United
States due to the low domestic rate of Zika incidents, and the test
will be available on an Export Only basis.
About Co-Diagnostics, Inc.:Co-Diagnostics, Inc., a Utah
corporation, is a molecular diagnostics company with a proprietary
diagnostic testing technology and development platform that intends
to manufacture and sell reagents used for diagnostic tests that
function via the detection and/or analysis of nucleic acid
molecules (DNA or RNA), and license the use of its platform to
other non-competing developers.
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/20181018005308/en/
Company Contact:Co-DiagnosticsAndrew BensonCo-Diagnostics
Investor
Relations801-438-1036investors@codiagnostics.comorInvestor
Contact:Lytham Partners, LLCJoe Diaz, Robert Blum and Joe
Dorame602-889-9700codx@lythampartners.com
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