Co-Diagnostics Receives CE Mark for Tuberculosis Test Kit
July 25 2018 - 6:30AM
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™ MTB Test 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 tuberculosis in European
Union states and other markets that accept a CE-IVD mark as valid
regulatory approval.
The World Health Organization (WHO) confirms that as of 2016,
the latest year for which data is available, tuberculosis (TB) is
one of the top 10 causes of death globally, proving fatal to 1.7
million people, and is the leading killer of individuals infected
with HIV. Prompt and accurate TB treatment is also believed to have
saved 53 million lives between 2000 and 2016, with a success rate
as high as 83% in 2015. However, symptoms of tuberculosis may be
mild or non-existent early on, and many affected people seek a
diagnosis too late after the disease has advanced, which is then
more difficult to treat and more likely to be fatal. In some
regions, cost prohibits residents from seeking a tuberculosis
diagnosis.
Dwight Egan, Chief Executive Officer of Co-Diagnostics,
remarked, “This granting of this CE mark represents a milestone not
only for Co-Diagnostics, but for all individuals in need of an
affordable, high-quality TB diagnostic in areas not blessed with
wealth or access to philanthropic subsidies. Our proprietary design
platform and CoPrimer™ technology, on which this test was built,
are now also being used to design tests for HIV and multi-drug
resistant tuberculosis (“MDR-TB”). These diagnostics are in high
demand where TB is prevalent and will further augment the tools
available to people in those areas, in addition to expanding the
Company’s footprint there as well.”
Co-Diagnostics will manufacture its Logix Smart MTB test in the
Company’s ISO 13485:2016 facility for the development and
manufacture of IVD Medical Devices located in Utah, USA, and at
this time is not seeking approval by the FDA for sale in the United
States due to the low domestic rate of tuberculosis incidents.
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). The Logix Smart MTB Test
detects DNA of mycobacteria tuberculosis (MTB) complex members and
functions via real-time polymerase chain reaction (PCR) to detect
and amplify the IS6110 and MPB64 regions of the MTB genome.
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. 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/20180725005242/en/
Company Contact:Co-Diagnostics, Inc.Andrew
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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