Co-Diagnostics has begun shipping its PCR Pro instruments, Co-Dx polymerase chain reaction (PCR) mycobacterium tuberculosis (MTB) test kits for TB, and sample preparation instruments to CoSara Diagnostics, its joint venture in India.

These shipments will support upcoming clinical performance studies of the TB test on the PCR platform, as the company finalises preparations for trial initiation.

This development aligns with recent guidance from the World Health Organization (WHO) concerning tuberculosis molecular diagnostics in India.

According to the WHO’s 2025 Global Tuberculosis report, global TB incidence declined by only 12% since 2015, well below the End TB Strategy target reduction of 50%.

Earlier this month, the WHO issued recommendations supporting near-point-of-care (NPOC) molecular diagnostics and easy-to-collect tongue swabs for patients unable to produce sputum samples.

These measures aim to expand access to TB testing and address significant diagnostic gaps.

The Co-Diagnostics PCR testing platform and NPOC TB test kit are designed to align with this new WHO guidance.

Co-Diagnostics CEO Dwight Egan said: “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 fulfil that objective.”

The Co-Dx PCR platform remains subject to regulatory review and is not yet available for sale.

Co-Diagnostics recently entered an agreement with CoSara Diagnostics to expand its commercial and distribution territory into Sri Lanka, Nepal, Pakistan, and Bangladesh.