Co-Diagnostics, Inc. Announces Additional Grant Award for Tuberculosis Test in Development

7 November 2023

Company to use funds awarded by the Bill & Melinda Gates Foundation toward the tuberculosis test for its Co-Dx™ PCR platform

Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced a grant awarded by the Bill & Melinda Gates Foundation to support the tuberculosis (TB) test in development, designed to be run on the upcoming Co-Dx™ PCR platform*. The amount awarded is $8.976 million.

The Company's TB test, which Co-Dx has designed for afflicted markets worldwide highly burdened by the disease, will be applied towards regulatory and clinical validation activities, increasing manufacturing capacity, and additional platform software development.

The World Health Organization (WHO) has highlighted the need to dramatically increase the availability of affordable, high-quality, point-of-care TB diagnostics to enable more rapid treatment decisions for TB, a disease that has a mortality rate of about 50% if left untreated.

Dwight Egan, CEO of Co-Diagnostics said, "Co-Dx is committed to making point-of-care TB diagnostics more accessible around the world, and we are pleased that this commitment will be supported by the additional proceeds of this new grant as we follow through on our mission to prevent the spread of infectious diseases by increasing the availability of PCR diagnostics worldwide. The WHO estimates that nearly 40% of TB cases went undiagnosed in 2021, or roughly 4.2 million, which represents a significant opportunity for this new platform to make a positive impact."

The grant will leverage the existing infrastructure and manufacturing capabilities of Co-Diagnostics' joint venture in India, CoSara Diagnostics. Those assets will be enhanced and expanded to help meet the anticipated demand for testing once the Co-Dx PCR platform, including the associated TB test, is available.

Egan continued, "Co-Dx supports the WHO's and United Nations' joint initiative to end the global TB epidemic by 2030, and we expect that this new grant will help to accelerate the role the Company is able to play in that initiative and to address the shortfalls in TB diagnoses and treatment in the wake of COVID-19."

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