MTB Screening Test Could Replace Smear Microscopy with Saliva Sample

In 2021 alone, it accounted for over 10 million infections worldwide, resulting in 1.6 million deaths. Unfortunately, around 4 million infections, which equates to two out of every five cases, remain undiagnosed and untreated, complicating efforts to control the disease. In countries with lower to middle incomes, where MTB is most widespread, diagnosis is typically performed via smear microscopy using sputum samples. This method, however, has notable limitations, especially in remote locations and when diagnosing specific patient groups like children and the elderly, who often find it challenging to produce sputum. As a result, diagnosing MTB presents a formidable healthcare issue. The World Health Organization has endorsed the use of molecular diagnostic tests that can work with different types of samples, such as saliva, thereby improving the accessibility of testing. Now, a breakthrough in MTB detection paves the way for affordable testing that could have a profound impact on MTB eradication efforts in heavily affected countries like India and Indonesia.

Gemina Laboratories (Vancouver, Canada) and ReadyGo Diagnostics (Bath, UK) have successfully demonstrated that it is possible to utilize saliva for MTB detection through a molecular diagnostic test. This groundbreaking achievement is a result of a partnership initiated in January 2023. The companies have demonstrated the feasibility of detecting MTB in saliva using the ReadyGo GEO platform. Following this success, Gemina and ReadyGo will now move forward to complete product development and aim to release the MTB Screening Test in 2024. The innovative product will be capable of replacing smear microscopy with a simple saliva sample and providing results within 30 minutes while proving to be highly cost-effective. Post-feasibility, the team plans to bring a compact laboratory instrument to market, projected to cost less than USD 1000 with a per-test cost of just USD 5, thereby advancing near-patient field testing for MTB.

"I'm delighted to be seeing such significant results, so quickly, from our partnership with ReadyGo Diagnostics," said Brian Firth, CEO of Gemina. "Our focus is developing better diagnostics that are not only highly effective, but affordable and deployable anywhere at any time, and our goal with ReadyGo was to create better diagnostic tests for managing patients with tuberculosis. The fact that we have proven feasibility of detecting MTB in saliva opens the door to a fundamental improvement in human health and has the potential to be a significant advancement towards eradicating Tuberculosis worldwide."

"I'm thrilled about our continued progress and collaboration with Gemina in establishing a tuberculosis diagnostic platform using saliva as the primary sample," added Ben Cobb, CEO of ReadyGo Diagnostics. "We understand the pressing need for an affordable triage tool that can replace smear microscopy, particularly in resource-constrained areas of the world. Using our experience and the tools at our disposal has been immensely beneficial in developing this test and I'm pleased with the progress we've achieved. We are dedicated to becoming the preferred development partner for companies seeking to create cost-effective molecular diagnostics for patients across diverse healthcare environments."

Related Links:
Gemina Laboratories
ReadyGo Diagnostics