Co-Diagnostics (NASDAQ:CODX) Gets “Indian FDA” Approval for Infectious Disease Testing in One of the World’s Biggest Markets
New York City, Dec. 03, 2019 (GLOBE NEWSWIRE) -- 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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