Co-Diagnostics, Inc. Receives CE Mark for Zika Screening Test
October 18, 2018
Company’s Logix Smart™ Zika Test to be available for purchase with
CE mark
SALT LAKE CITY–(BUSINESS WIRE)–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.
Contacts
Company Contact:
Co-Diagnostics
Andrew Benson
Co-Diagnostics
Investor Relations
801-438-1036
investors@codiagnostics.com
or
Investor
Contact:
Lytham Partners, LLC
Joe Diaz, Robert Blum and
Joe Dorame
602-889-9700
codx@lythampartners.com