Co-Diagnostics (NASDAQ:CODX) Gets “Indian FDA” Approval for Infectious Disease Testing in One of the World’s Biggest Ma...
December 03 2019 - 9:00AM
Co-Diagnostics, Inc.
(Nasdaq: CODX), a biotech
company with a patented platform for the development of molecular
diagnostic tests, released what could arguably be the most
significant news in its history earlier today with the announcement
that Indian regulators have approved five in vitro diagnostic
assays to be manufactured and sold by CoSara Diagnostics Pvt Ltd.,
the company’s joint venture for manufacturing in India. The
approved tests include those for tuberculosis, malaria, hepatitis
B, hepatitis C, and human papillomavirus.
Why is this important? The Indian Central Drug
Standard Control Organization (or “CDSCO”) is the regulatory body
responsible for approving pharmaceuticals and medical devices for
use in the Indian healthcare market, serving a parallel function as
the Food and Drug Administration in the United States, making CDSCO
approval in India analogous to FDA approval in the US. That means
that this news is essentially equivalent to a company receiving FDA
approval for five diagnostics at the same time—but for a population
roughly 4 times larger than the US, and one that is heavily
afflicted by all of the diseases in question.
Co-Diagnostics announced the inauguration of the
JV manufacturing plant earlier this year, one of the first of its
kind in India. Today’s release indicates that the wait between
inauguration and production is due to the rigorous inspection
process of the tests and plant following its completion, marking
this as the first time CoSara has been able manufacture and sell
tests from its facility.
The news also announced that distributors are
already taking pre-orders for the newly approved diagnostics. With
additional tests on the way, including HIV and a multiplexed panel
for blood-bank screening, and ambitions for global expansion, the
test approvals and impending revenue are major—and welcome—steps
forward for a company that has devoted so much time to a healthcare
market that the company CEO has described as soon to become the
largest on the planet.
Disclosure: Co-Diagnostics Inc is a client of BDA
International.
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