Sample Prep Instrument to Empower Decentralized PCR Testing for Tuberculosis

Tuberculosis remains the deadliest infectious disease worldwide despite being both treatable and curable when diagnosed early. A major barrier to timely diagnosis is that PCR-based TB testing is still largely centralized, requiring complex and costly sample preparation that limits access in primary health centers. Preparing patient samples safely and efficiently at the point of care has been one of the key challenges preventing wider adoption of molecular TB diagnostics. A newly developed sample preparation solution now addresses this bottleneck by simplifying workflow, reducing costs, and enabling safer decentralized testing.

Co-Diagnostics (Salt Lake City, UT, USA) has developed a proprietary sample preparation instrument to support its point-of-care Co-Dx PCR Mycobacterium Tuberculosis test. The device is engineered for low-resource and near–point-of-care environments and supports both sputum samples and a novel tongue swab collection method. Designed with single-button operation, it eliminates the need for measuring or dispensing tools and incorporates an integrated safety step that inactivates live organisms, helping protect test operators while preparing genetic material for PCR analysis.

The instrument has been developed to address longstanding limitations of TB PCR testing outside centralized laboratories, where extraction workflows are often time-consuming and expensive. By enabling rapid and standardized sample processing with minimal training, the device supports consistent preparation of samples suitable for real-time PCR. Clinical evaluations of the associated MTB test are expected to begin in India, a setting where decentralized diagnostics could significantly expand access to molecular testing.

This streamlined sample preparation approach could accelerate the transition of PCR-based TB testing from district hospitals to tens of thousands of primary health centers currently reliant on microscopy. In addition to tuberculosis, the platform is designed to support the preparation of other sample types at the point of care, opening pathways for future expansion into blood-borne pathogens. The technology represents a step toward broader global access to affordable, high-quality molecular diagnostics in settings with the greatest unmet need.

“We believe that the new device is also a step towards affordable preparation of other sample types at the point-of-care, creating opportunities to expand into blood-borne pathogens and representing a major step forward in our mission to make PCR testing more accessible worldwide, especially in challenging environments with the most pressing need for affordable life-saving diagnostics,” said Dwight Egan, Chief Executive Officer of Co-Diagnostics.

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