GHLabs x GADx: PoC innovation in molecular diagnostics

The sensitivity of molecular testing is now being revolutionised for point-of-care (PoC) usage. PCR, known for its high sensitivity and specificity, is the gold standard in diagnosing many infectious diseases. However, its availability has been limited to specialised labs, creating challenges, especially in low- and middle-income countries (LMICs) where the cost of sample transportation and testing is often prohibitively high and the time to result long.

Addressing this, GADx is collaborating with Global Health Labs and other international partners to create an affordable, accessible diagnostic platform. This innovation aims to provide the accuracy of PCR testing in a format that can be easily used by healthcare providers at the point of care, even with minimal infrastructure and basic training. This approach particularly benefits LMICs and remote areas where advanced lab facilities are scarce.

In a groundbreaking effort, we have developed a test that merges the highly specific technique of isothermal nucleic acid amplification with lateral flow detection. The test device is ingeniously designed, featuring a heated chamber for amplification and a switch mechanism for transferring the amplified product to a lateral flow strip. This enables the delivery of results in under 45 minutes – significantly improving speed and convenience.

This project is a confluence of expertise from various fields, including molecular diagnostics, lateral flow assay, microfluidics, thermodynamics, electronics, and advanced manufacturing technologies. It represents a significant step forward in expanding diagnostic capabilities in LMICs and remote locations.

While the immediate focus of this initiative is on developing an assay for tuberculosis, the technology holds vast potential for diagnosing a wide range of diseases that are currently reliant on nucleic acid amplification methods in laboratories. The overarching goal is to make molecular diagnostics more accessible and efficient, significantly impacting global health, especially in underserved regions.

Frequent testing is invaluable and so it is vital to find ways to drive down the cost of kits and increase production levels. As a social enterprise, GADx can transform this process because it ‘breaks the link’ of ‘having to make profit for shareholders’.

Paul Davis
Co-founder of Mologic and pioneer of lateral flow diagnostics.