30-Minute Molecular Assay to Revolutionize Tuberculosis Diagnosis within Near Patient Settings

By HospiMedica International staff writers
Posted on 20 Apr 2023

Mycobacterium tuberculosis (MTB) is an extremely contagious airborne disease. In low- and middle-income countries where it is most widespread, diagnosis typically relies on smear microscopy using sputum samples. However, this method has notable limitations, particularly in remote areas and when diagnosing specific patient groups like children and the elderly who may struggle to produce sputum. As a result, diagnosing MTB remains a significant healthcare challenge. The World Health Organization (WHO) has recommended adopting molecular diagnostic tests that can utilize alternative samples, such as saliva, to make testing more accessible. A new partnership now seeks to implement these recommendations by replacing smear microscopy with a simple saliva test that can provide a sample to answer result within 30 minutes.

ReadyGo Diagnostics Ltd. (Bath, UK) has entered into an assay development agreement with Gemina Laboratories Ltd. (Vancouver, Canada). ReadyGo will develop, optimize, and validate an MTB detection assay for Gemina to use on ReadyGo's off-grid isothermal diagnostic platform, Geo. The Geo platform can deliver quick results in any location within 30 minutes, and is anticipated to play a vital role in diagnosing MTB in near-patient settings, ultimately improving patient management and outcomes.

Image: Geo is a compact, portable, testing platform that provides results within 20 minutes of sample collection (Photo courtesy of ReadyGo)

Despite its small size, Geo represents a breakthrough in diagnostic testing. The ultra-portable device, with an 8cm cubed footprint, can conduct molecular tests in various settings, ranging from a compact wet laboratory to a muddy field. Geo employs ReadyGo's Flex reagents, which do not require a cold-chain for a true off-grid, go-anywhere test platform. Pre-measured reagents eliminate the need for a skilled operator or accurate pipetting. Moreover, Geo can accommodate various isothermal chemistries and melt-curve analyses for molecular examination. The device can analyze eight samples simultaneously and is compatible with any assay that requires fluorescence or colorimetric readouts. Geo does not necessitate RNA and DNA purification and can perform both singleplex and multiplexed tests.

“I'm excited about our partnership with ReadyGo Diagnostics. Our goal at Gemina Labs is to create better diagnostic tests for respiratory diseases,” said Brian Firth, CEO of Gemina. “We focus on tests that are effective at the front line of patient care whether that be in the field, the home or the primary clinic. For this reason we've been impressed by ReadyGo's platform, Geo and what it could mean for the diagnosis and treatment of tuberculosis. I'm really confident that by teaming up with ReadyGo, we'll be able to create a fast and accurate TB detection solution that can make a real difference in improving patient outcomes all around the world.”

“I'm really excited about our partnership with Gemina to create a simple platform for diagnosing tuberculosis,” added Ben Cobb, CEO of ReadyGo Diagnostics. “Having worked in this field for a long time, I know that a low-cost triage tool that can replace smear microscopy is desperately needed, especially in places with limited resources. We are proud of the progress made so far, and we're committed to becoming the go-to development partner for companies looking to create simple, cost-effective molecular diagnostics for different settings.”