#India #Salt Lake City #Co-Diagnostics #Tuberculosis #WHO Recommendations

Co-Diagnostics Sends Essential Diagnostic Materials to India for Tuberculosis Clinical Trials

In a significant stride towards combating tuberculosis (TB), Co-Diagnostics, Inc. (stock symbol: CODX) announced the shipment of essential diagnostic instruments and test kits to its joint venture in India. This initiative comes in the wake of recent guidance from the World Health Organization (WHO), which emphasizes the importance of improved TB testing methodologies.

The shipments include Co-Dx's acclaimed PCR Pro® instruments and Co-Dx™ PCR MTB test kits, necessary for the commencement of clinical performance studies. These studies aim to assess the efficacy of TB testing procedures on the Co-Dx PCR platform while adhering to the new WHO recommendations for point-of-care molecular diagnostics. This move signals a crucial step in closing the testing gaps that have persisted in TB diagnosis.

Recent WHO Recommendations

The WHO's 2025 Global Tuberculosis Report highlighted a mere 12% reduction in the global TB incidence since 2015, falling short of the ambitious target of 50%. In response to the mounting TB crisis, the WHO recently recommended the use of near-point-of-care (NPOC) molecular diagnostics and the utilization of tongue swab samples. This approach is particularly beneficial for patients who struggle to provide sputum samples, thereby enhancing access to TB testing.

According to Dwight Egan, CEO of Co-Diagnostics, the company's testing platform is already aligned with these new directives. This alignment reinforces Co-Diagnostics' commitment to facilitating widespread access to TB testing by using the latest technological advancements in molecular diagnostics. Egan stated, "Our design foresight in creating a testing platform that supports both sputum and tongue swab samples coincides perfectly with the recommendations laid out by the WHO."

Addressing the TB Burden in India

Despite a reported reduction in TB incidence by 21% since 2015, India continues to bear a heavy burden, accounting for about 25% of global TB cases. The commencement of these clinical studies is imperative as India seeks to enhance its TB testing capacity and, ultimately, save lives. The newly developed Co-Dx PCR MTB test has shown promising preclinical results, paving the way for further evaluation in clinical settings.

With the recent licensing of the PCR Pro® instrument from the Central Drugs Standard Control Organization (CDSCO) in India, Co-Diagnostics is poised to begin clinical performance studies. Egan emphasized the company's strategic alignment with WHO guidelines, indicating that the forthcoming studies will play a pivotal role in the approval process with Indian regulatory authorities.

The Future of TB Testing

Co-Diagnostics has a clear mission: to develop and promote access to precise, life-saving PCR tests. As the fight against tuberculosis continues, the company is dedicating its resources to ensuring that timely and accurate testing is available, which brings hope in the battle against this resilient disease.

As these clinical studies commence in India, global health stakeholders will monitor the outcomes closely, anticipating not just improvements in TB diagnostics but also a sustained effort to tackle the ongoing public health challenge presented by tuberculosis worldwide.

The commitment shown by Co-Diagnostics reflects a broader awareness of the pressing needs in global health, particularly in endemic regions where TB continues to claim lives and hinder healthcare progress. With innovative solutions like the Co-Dx PCR testing platform, the company aims to spearhead a new era in disease prevention and diagnosis on a global scale.

Note: The Co-Dx testing platform, including the PCR Home®, PCR Pro®, mobile app, and associated tests, is subject to regulatory review and is currently not available for sale.