SALT LAKE CITY, April 28, 2021 /PRNewswire/
-- Co-Diagnostics, Inc. (Nasdaq: CODX) (the
"Company"), a molecular diagnostics company with a unique, patented
platform for the development of diagnostic tests, announced today
that its Indian manufacturing facility, CoSara Diagnostics Pvt.
Ltd. ("CoSara," or the "JV", a Joint Venture with Synbiotics Ltd)
has been featured in recent press highlighting its actions to
provide much-needed COVID-19 diagnostics as a wave of infections
has led to the world's worst COVID-19 outbreak since the pandemic
began.
The article in the Times of India and others discusses the increased
capacity that has resulted from CoSara's efforts to provide test
kits and technical support for CoSara's government and private lab
customers. In particular, the media has noted the extraordinary
efforts of a CoSara team of 6 women who have worked to increase
capacity at the manufacturing facility from roughly 8,000 COVID-19
PCR tests per day a year ago to around 40,000 per day now, after
being one of the first companies to provide PCR test kits to the
state of Gujarat.
Last week the Company shipped an emergency supply of raw test
materials to the JV to help combat the surge of cases, which comes
as the Company marks the 2-year anniversary of the inauguration of
the CoSara manufacturing facility. Within 8 months of the plant
inauguration in 2019, CoSara received in vitro ("IVD")
clearance from the Central Licensing Authority to manufacture and
sell five diagnostic assays including Mycobacteria tuberculosis,
hepatitis B, hepatitis C, malaria, and human papillomavirus
16/18.
These tests served as a base for initial sales and entry into
the market up until April 2020 when
the JV became the first company headquartered in India to get a license to manufacture COVID-19
test kits. CoSara was highlighted in several news outlets as
one of six companies that India
would depend on to win the fight against COVID-19 and has remained
steadfast through the pandemic manufacturing over two million
tests. The JV's dedication to the Indian people in providing
quality real-time PCR tests has expanded territory to about 160
current customers, which includes equipment installation in 73
laboratories, over 40 of which did not have access to PCR
technology prior to becoming CoSara customers. CoSara partners and
distributors also assisted in setting up nearly a dozen labs from
the ground-up.
Mohal Sarabhai, CEO of Synbiotics, remarked, "In agreement with
the 'make in India' initiative and
the response to the COVID-19 crisis, CoSara has risen to the
occasion as we play a critical role in helping to stem the tide of
infections spreading across the country. We are immensely proud of
all of the notable achievements that CoSara, Synbiotics, and
Co-Diagnostics' staff have already worked to bring to fruition, but
especially the boots-on-the-ground efforts 7 days per week to
provide these vital, compassionately-priced diagnostics to the
population.
"CoSara recently also joined the Center for Cellular and
Molecular Platforms (C-CAMP) Indigenization of Diagnostics program
to participate in efforts that bring together public and private
stakeholders to build large capacity supply of COVID-19 molecular
diagnostic reagents in India,"
continued Mr. Sarabhai.
"CoSara forms an integral part of our mission to bring
high-quality, affordable molecular diagnostics solutions to the
world, especially to the people and countries who need them the
most," commented Dwight Egan,
Company CEO. "Nowhere is that more applicable than India as this unprecedented surge has seen the
need for gold-standard PCR diagnostics reach heights that were
unheard of prior to the global pandemic, and at pricing levels that
many companies are unable to match. We are pleased to be able to
play a role in this crisis through our participation in the joint
venture."
Including the five Sarageneā¢ assays mentioned above and its
COVID-19 single gene and 2-gene Saragene assays, CoSara now also
has IVD licenses for 9 diagnostics, and is completing the
verification and validation steps required for submission to the
Central Drug Standard Control Organization ("CDSCO") for several
more. These include dengue, a dengue/chikungunya duplex test, a
drug resistance assay for tuberculosis, an influenza A/B with
COVID-19 multiplex, viral load tests for HIV, hepatitis B, and
hepatitis C, and a COVID-19 Direct Saliva test, among others. The
JV is already awaiting the export quota to be assigned for
additional tests for the surrounding Asia-Pacific, African, and Middle East territories, and is in the process
of applying CE-IVD clearance for several of its products.
CoSara has also identified partnerships to help promote
education, innovation, and translation of medical devices to fill
gaps and meet the growing needs. Over the last two years CoSara has
partnered with Biomolecular Systems and BioRad to provide real-time
PCR instrumentation throughout India.
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.
About CoSara Diagnostics Pvt. Ltd:
Established in 2017, CoSara is a Joint Venture between
Co-Diagnostics Inc. and Synbiotics Ltd, a group company of Asence
Inc., a U.S. company that specializes in supplying pharmaceutical
products to international markets across 35 countries. Asence and
Synbiotics are both subsidiaries of Ambalal Sarabhai Enterprises
Ltd., a continuation of one of the oldest and most respected
manufacturing institutions in India in operation today. Using the core
competencies of its partner companies, CoSara provides high-quality
molecular diagnostics products from its manufacturing plant in
Ranoli, India, the first of its
kind in India for manufacturing
in vitro molecular diagnostic products under Good
Manufacturing Practices.
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 rely
on any forward-looking statements. Any forward-looking statement
made by the Company in this press release is based only on
information currently available to the Company and speaks only as
of the date on which it is made. 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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SOURCE Co-Diagnostics