Co-Diagnostics Completes Submission of CE Mark Registration for Tuberculosis Screening Test
17 Julio 2018 - 5:30AM
Business Wire
Company’s Logix Smart™ MTB Test to be
available for purchase with CE mark in August 2018
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 technical file has been submitted for
registration with the European Community, and that the CE marked in
vitro diagnostic (“IVD”) is expected to be available for purchase
early in August in markets that accept a CE mark as valid
regulatory approval.
Dwight Egan, Chief Executive Officer of Co-Diagnostics,
commented, “The CE marking of the Company’s tuberculosis test, our
flagship product for infectious disease, represents a major
milestone for Co-Diagnostics. This newest iteration of our MTB
screening test has been tailored to target detection of the two
genes present in a broad range of tuberculosis infections, to
greatly mitigate the potential of false negatives and improve the
diagnosis and prognosis of patients afflicted with this disease
worldwide. Being built on Co-Diagnostics’ proprietary CoPrimer™
design platform also means that 'primer-dimers,' the
often-occurring phenomenon that leads to false positives in these
types of diagnostics, are virtually eliminated.”
The technical file dossier 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 by
the end of July, at which point sales of the product may commence
as an IVD with the CE marking included. 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.
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.
Mr. Egan continued, “The key component to battling tuberculosis
is an early, accurate, and affordable diagnosis. We are confident
that the time we have taken to ensure this test meets our high
standards of quality and performance will allow us to better meet
the global demand for detection of a disease with 99.9% of
infections occurring outside of the United States, and that causes
over 1.5 million deaths per year. Roughly 95% of these deaths occur
in low and middle-income countries, which includes those in Eastern
Europe in addition to many across Central America and the Caribbean
basin. In the case of the latter, the Departments or Ministries of
Health recognize clearance by the European Community as valid
regulatory approval to allow sale of CE marked products throughout
their jurisdictions.”
Co-Diagnostics will manufacture its Logix Smart MTB test in the
Company’s ISO 13485:2016 facility for 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.
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/20180717005411/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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