Co-Diagnostics Inc. (NASDAQ: CODX) has shipped PCR Pro instruments and tuberculosis test kits to its joint venture CoSara Diagnostics Pvt. Ltd. in India to begin clinical performance studies of its TB test platform.

The shipment includes PCR Pro instruments, Co-Dx PCR MTB test kits for tuberculosis, and proprietary sample preparation instruments. The company stated these materials are necessary to initiate clinical studies in the near term.

The timing aligns with World Health Organization guidance issued March 9 recommending near-point-of-care molecular diagnostics and tongue swab samples for TB testing. The WHO noted that global TB incidence has decreased only 12% since 2015, falling short of its End TB Strategy target reduction of 50%.

According to the WHO's 2025 Global Tuberculosis Report, India accounts for approximately 25% of global TB cases despite achieving a 21% reduction in TB incidence since 2015.

"We are pleased that our foresight in designing the Co-Dx PCR testing platform and TB test for broad accessibility in point-of-care and near-point-of-care settings, and to be operated with either sputum or tongue swab samples, is consistent with the direction of the WHO's recommendation," said CEO Dwight Egan.

The company previously announced that its PCR Pro instrument received a license from India's Central Drugs Standard Control Organization to be manufactured and sold as a medical device instrument. Co-Diagnostics expects to announce the start of clinical performance studies in India as it prepares for regulatory submission to Indian authorities.

The Co-Dx PCR platform and associated tests remain subject to FDA and other regulatory reviews and are not yet available for sale.