Co-Diagnostics JV CoSara Receives Indian Regulatory Approval for Five Diagnostic Assays
03 Diciembre 2019 - 5:30AM
Business Wire
CoSara Saragene™ tests for tuberculosis,
malaria, hepatitis B, hepatitis C, and human papillomavirus now
available for sale and distribution as in vitro diagnostics
Co-Diagnostics, Inc. (Nasdaq: CODX) (the “Company”), a
molecular diagnostics company with a unique, patented platform for
the development of molecular diagnostic tests, announced today that
CoSara Diagnostics Pvt Ltd (“CoSara,” or the “JV”), their joint
venture for manufacturing, has obtained regulatory clearance for
five tests to be manufactured and sold as in vitro diagnostics
(“IVDs”) from their facility in Ranoli, India.
The Saragene™ tests for Mycobacterium tuberculosis, malaria,
hepatitis B, hepatitis C and human papillomavirus (HPV) meet the
requirements of the Central Drug Standard Control Organization
(“CDSCO”) Medical Device Rules (MDR) 2017, File no.
29/Misc./3/2017-DC (292), to be manufactured and sold as IVDs.
CDSCO approval was granted following the completion of the CoSara
manufacturing facility and a comprehensive inspection of the
location, presentation of the technology, quality system,
procedures, product validation data and performance evaluation by
an independent NABL & CAP accredited laboratory. The licenses
and regulatory clearance allow CoSara for the first time to
manufacture and sell the tests for the detection of the respective
pathogens and microorganisms.
CoSara distributors have begun taking pre-orders for the five
IVDs, and the Company expects sales to ramp quickly. The JV has the
exclusive manufacturing rights in India for the complete menu of
Co-Diagnostics infectious disease molecular diagnostics kits,
designed by Co-Diagnostics using their patented CoPrimer™
technology platform.
Additional tests which are expected to be submitted to the CDSCO
for approval consist of those for drug-resistant tuberculosis, HIV
and more, including a multiplexed panel specifically for blood-bank
screening.
Dwight Egan, Company CEO, remarked, “India is soon to become the
largest healthcare market on the planet and the best place for
CoPrimer-powered products to be manufactured and distributed is
from within the country itself. Being able to sell fully approved
IVDs to this market represents the next stage in our growth as we
establish Co-Diagnostics to be a leading innovator of high-quality,
affordable diagnostics solutions. We are excited to be taking this
next step in our growth with such a distinguished partner and are
eager to see returns on the time and effort we have spent to get to
this point.”
The CoSara plant is one of the first facilities for
manufacturing molecular diagnostics in India and has been designed
to meet both current and future requirements for medical device
manufacturing, which are expected to be implemented by the Indian
government. CoSara is a joint venture between the Company and
Synbiotics Pvt 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.
“We are honored to be the manufacturer of the first indigenous
PCR-based diagnostic kits in India,” said Mr. Mohal Sarabhai, CEO
of Synbiotics. “Our team has worked tirelessly this year, ensuring
the facility and procedures meet or exceed the requirements to
fulfill our mandate of providing cutting-edge molecular diagnostics
technology to India. The goals of the ‘make in India’ initiative
aligns perfectly with those of CoSara, and we look forward to
serving not only the Indian market but to receiving the CE markings
and other necessary regulatory approvals that will allow CoSara
Diagnostics to expand on a global scale.”
On Thursday, December 5, Co-Diagnostics, Inc. will hold an
invitation-only press conference for members of the media and
financing partners in New York City, New York, to provide context
and impact of the news on the Company. Contact Jennifer Webb of
Coltrin & Associates at jennifer_webb[at]coltrin.com to request
an invitation.
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 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 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/20191203005411/en/
Andrew Benson Head of Investor Relations +1 801-438-1036
a.benson@codiagnostics.com
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