Co-Diagnostics, Inc. Enters Into Lease for New, Upgraded Laboratory Facility
December 19 2017 - 6:30AM
Business Wire
Laboratory will meet CGMP Requirements of
FDA; Will be BSL-2 to allow enhanced in-house verification and
validation activities
Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular
diagnostics company with a unique, proprietary platform for the
development of diagnostic tests, announced today leasing a new and
upgraded, CGMP-ready and Biological Safety Level 2 laboratory
facility in Salt Lake City, Utah.
Co-Diagnostics CEO Dwight Egan remarked, “The upgraded facility
is nearly perfectly appointed with the necessary amenities to
immediately commence production operations. This site will help us
to reduce our dependence on outside locations to complete robust
validations of the Company’s products, and represents the next step
in our growth as a world-class developer of molecular diagnostics.
Our trained personnel will now have the capacity to manufacture
high-quality products that meet the standards of the U.S. Food and
Drug Administration, preparing the Company to seek future FDA
approvals for sale domestically and export abroad.”
Mr. Egan continued, “This is another important milestone in the
development of Co-Diagnostics as an emerging leader in the
molecular diagnostics industry. We are bringing disruptive
technology to the market that will dramatically improve test
accuracy by reducing false positives via our CoPrimers™ technology,
and facilitate multiplexing to test for a broad range of disease
states in a patient in a single test which will cut costs to
healthcare systems. We are excited with the opportunities ahead in
the coming years.”
Biocontainment precautions are required for the safe handling of
potentially dangerous biological agents in a laboratory
environment. Biological Safety Levels (“BSL”) are determined by the
Centers for Disease Control (“CDC”) as a way to categorize which
specific controls are necessary for the containment of biological
agents based on their risk, transmissibility, severity, etc.
Containment levels range from the lowest, BSL-1, to BSL-4, with
each level requiring increasingly strict precautions. The Company’s
BSL-2 lab will allow trained staff members to conduct certain
verification and validation activities on human samples in-house
rather than sending investigational use test kits to other
facilities. From the FDA website, a CGMP-certified facility refers
the Current Good Manufacturing Practice regulations enforced by the
FDA, and provides systems that assure proper design, monitoring,
and control of manufacturing processes and facilities. The new
facility will also house the corporate headquarters for the
Company.
About Co-Diagnostics,
Inc.
Co-Diagnostics, Inc., a Utah corporation, is a molecular
diagnostics company that has developed and 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 to sell diagnostic equipment from other manufacturers as
self-contained lab systems.
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.
Disclaimer
This news release does not constitute an offer to sell or a
solicitation of an offer to buy the securities described herein,
nor shall there be any sale of these securities in any state or
jurisdiction in which such an offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction.
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version on businesswire.com: http://www.businesswire.com/news/home/20171219005534/en/
Company Contact:Co-Diagnostics, Inc.Andrew Benson,
801-438-1036Co-Diagnostics Investor
Relationsinvestors@codiagnostics.comorInvestor Contact:Lytham
PartnersJoe Diaz, 602-889-9700codx@lythampartners.com
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