Business
Co-Diagnostics Ships Diagnostic Materials to India for Initiation of Tuberculosis Clinical Studies Following Recently Issued Guidance from the World Health Organization
The near-term commencement of clinical studies is expected to align with recent WHO tuberculosis recommendations for near-point-of-care molecular testing and
About this update from Co-diagnostics, Inc.
[{"type":"text","content":"The near-term commencement of clinical studies is expected to align with recent WHO tuberculosis recommendations for near-point-of-care molecular testing and utilizing tongue swab samplesNew recommendations are aligned with the design of Co-Dx's proprietary test, platform, and missionSALT LAKE CITY, March 25, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (\"Co-Dx\" or \"the Company\"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has commenced shipments of PCR Pro® instruments*, Co-Dx™ PCR MTB test kits* for tuberculosis (\"TB\"), and proprietary sample preparation instruments to its joint venture CoSara Diagnostics Pvt. Ltd. (\"CoSara\") in India. These materials are necessary to begin clinical performance studies of the TB test on the PCR platform, as the Company completes final steps toward initiating those studies in the near term.\n \n \n \n \n \n \n \nAccording to the World Health Organization's (\"WHO\") 2025 Global tuberculosis report, the global TB incidence rate was only reduced by 12% since 2015, compared to the WHO's End TB Strategy target reduction rate of 50%. On March 9, the WHO issued recommendations for the first time on near-point-of-care (\"NPOC\") molecular diagnostics and easy-to-collect tongue swabs for patients who cannot produce sputum samples, in order to expand access to TB testing and help close critical diagnostic gaps.The Company's PCR testing platform* and NPOC TB test kit are already aligned with this new guidance.Co-Diagnostics CEO Dwight Egan remarked, \"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.\"Despite achieving a 21% reduction in TB incidence since 2015, India continues to account for approximately 25% of global cases according to the 2025 Global tuberculosis report.Mr. Egan continued,...