Co-Diagnostics Ships TB Diagnostic Materials to India for Clinical Studies

Co-Diagnostics, Inc., a molecular diagnostics company, has announced the shipment of its PCR Pro® instruments, Co-Dx™ PCR MTB tuberculosis test kits, and proprietary sample preparation systems to its joint venture CoSara Diagnostics Pvt. Ltd. in India. These shipments mark a key step toward initiating clinical performance studies for its TB diagnostic platform.

The move comes in alignment with recent guidance issued by the World Health Organization (WHO), which for the first time recommended near-point-of-care (NPOC) molecular diagnostics and the use of easily collected tongue swab samples for TB testing. These recommendations aim to expand access to testing, particularly for patients unable to produce sputum samples, and help address persistent diagnostic gaps.

Co-Diagnostics stated that its PCR testing platform and TB test kit are already designed in line with these recommendations, supporting both sputum and tongue swab-based testing approaches.

According to the WHO’s 2025 Global Tuberculosis Report, global TB incidence has declined by only 12% since 2015, significantly below the targeted 50% reduction under the End TB Strategy. India continues to bear a substantial burden, accounting for approximately 25% of global TB cases.

“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. The WHO's recommendation underscores the importance of these technological advances in molecular diagnostics to ensure early and accurate TB testing. Co-Diagnostics' mission to develop and increase access to life-saving PCR tests is aligned to fulfill that objective.”

The company noted that its TB test has demonstrated encouraging preclinical results in third-party evaluations, supporting further clinical validation. It also highlighted that its PCR Pro® instrument has received a license from the Central Drugs Standard Control Organization (CDSCO) for manufacturing and sale as a medical device in India.

“The Co-Dx PCR MTB test has continued to generate encouraging third-party preclinical results, supporting further clinical evaluation. We recently announced that the PCR Pro® instrument received a license from the CDSCO to be manufactured and sold as a medical device instrument, and expect to announce the commencement of clinical performance studies in India in the near future as we prepare for a submission to the Indian regulatory authorities for clearance.”