Co-Diagnostics, Inc. Ships Product to India for Validation Study
February 21 2018 - 5:30AM
Business Wire
Shipment includes 10,000 tests to be sold as
Research Use Only by Joint Venture
Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular
diagnostics company with a unique, proprietary platform for the
development of molecular diagnostics, announced today a product
shipment to India containing tests to be sold as Research Use Only
as well as others to be used in validation studies in that
country.
The validation study for the most recent iteration of the
Company’s test for tuberculosis will be conducted at the All India
Institute of Medical Sciences (“AIIMS”). With nearly 20% of the
world’s tuberculosis cases in India, a substantial market exists in
that country for affordable, accurate diagnostic solutions. Results
of the study will be used to complete the application to the
Central Drugs Standard Control Organization (“CDSCO”), the Indian
regulatory body for pharmaceuticals and medical devices, to allow
for free sale of the diagnostic test across the country. Prior to
approval by the CDSCO the tests will be sold as Research Use Only,
until authorization has been granted for use as an in-vitro
diagnostic. Ten thousand such tests were also included with the
shipment to be sold by CoSara Diagnostics Pvt Ltd, the Company’s
Joint Venture in India.
The shipment also contained other Co-Diagnostics products to be
used in third party performance validation studies, including a
test for human papillomavirus (HPV). Certain strains of HPV, HPV 16
and HPV 18, are known to account for nearly 70% of cases of
cervical cancers in women. The HPV test included in the shipment
was built on the Company’s patent-pending CoPrimer™ technology
specifically to identify the existence of these two strains of the
virus.
Dwight Egan, Co-Diagnostics CEO, remarked, “Completion of the
AIIMS study is the final hurdle before being able to pursue
approval by CDSCO, and we are confident that the results will bear
out the quality and competitiveness of Co-Diagnostics’ products.
The distribution network already in place with CoSara Diagnostics
is eager to commence sales of the newest version of our flagship
tuberculosis test. And with nearly a half million new cases every
year, and one quarter million female deaths worldwide per year from
cervical cancers, we also look forward to being able to introduce
our HPV test into the addressable market.”
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180221005489/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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