Co-Diagnostics, Inc. Announces Launch of Test for New Coronavirus
February 06 2020 - 3:30PM
Business Wire
Product launch and rapid development of the
Logix Smart™ 2019-nCoV coronavirus test facilitated by Company’s
proprietary technology platform
Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular
diagnostics company with a unique, patented platform for the
development of diagnostic tests, announced today that its research
use only (RUO) CoPrimer™ test for the 2019-nCoV coronavirus is
ready for sale to appropriate laboratories, hospitals, and
institutions in need of a solution to the current coronavirus
epidemic.
The announcement follows two weeks of efficient design,
development, and verification activities to ensure that the
polymerase chain reaction (PCR) test’s performance, first announced
on January 23, meets the requirements of a large and growing market
for coronavirus detection. The test was designed using the
Company’s proprietary process, including the CoDx Design™ software
system, to rapidly identify and verify the most optimal target on
the 2019-nCoV genome for a PCR assay. Co-Diagnostics believes that
the test’s unique design will provide enhanced accuracy when
detecting the presence of the coronavirus, including improved
specificity over tests designed on a different platform.
“Increased specificity is one of the hallmarks of tests built
using our patented CoPrimer platform,” remarked Dwight Egan, CEO of
Co-Diagnostics. “Leveraging our proprietary design process and
software has allowed us to quickly move this product from design
into commercialization, and to do so with the confidence that our
high-quality product meets our goal of providing an effective,
much-needed global diagnostic solution in an emergency
situation.
“As a result of our rapid development, we have already received
requests from customers in countries across the world to purchase
tests. Sales and shipments of products will be fulfilled from our
Utah headquarters to customers who have the capacity to utilize RUO
products to slow the spread of this epidemic.”
An outbreak of respiratory illness caused by the pneumonia-like
coronavirus has spread rapidly over the past several weeks, after
first being identified in the Chinese city of Wuhan on January 7.
Since that time, infections have been confirmed in 28 countries,
including 12 patients testing positive in the US, with over 28,000
cases world-wide (over triple that of SARS in 2002 and 2003), and
over 560 confirmed deaths, nearly all located within China. The
World Health Organization declared the novel strain of the
coronavirus a global health emergency on January 30, and on
February 4 the US Food and Drug Administration (FDA) granted
authorization for emergency use of in vitro diagnostic (IVD) tests
for the virus, after determining that the virus has significant
enough potential to affect national security or public health.
Mr. Egan continued, “We are pleased to be able to react so
quickly and commercialize this RUO version of our test that can
immediately be used by thousands of labs around the world. We are
already in communication with the FDA regarding clearance of our
2019-nCoV test on an emergency use basis. If approved, it will
allow us to commercialize the test as an IVD, reaching even more
markets affected by this disease. We are also pursuing a CE marking
for the European Union and any country or jurisdiction that allows
registration of IVD products that bear a valid CE marking, as well
as emergency use clearance in India for our manufacturing joint
venture in that country.”
About Co-Diagnostics, Inc.: Co-Diagnostics, Inc., a Utah
corporation, is a molecular diagnostics company that develops,
manufactures and markets a new, state-of-the-art diagnostics
technology. The Company’s technology is utilized for tests that are
designed using the detection and/or analysis of nucleic acid
molecules (DNA or RNA). The Company also uses its proprietary
technology to design specific tests to locate genetic markers for
use in industries other than infectious disease and license the use
of those tests to specific customers.
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 may include statements
regarding the (i) use of funding proceeds, (ii) expansion of
product distribution, (iii) acceleration of initiatives in certain
verticals or markets, (iv) capital resources and runway needed to
advance the Company’s products and markets, (v) increased sales in
the near-term, (vi) flexibility in managing the Company’s balance
sheet, (vii) anticipation of business expansion, and (viii)
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/20200206005913/en/
Andrew Benson Head of Investor Relations +1 801-438-1036
investors@codiagnostics.com
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