Gemina Laboratories and ReadyGo Diagnostics Achieve Mycobacterium Tuberculosis Diagnosis in Saliva

VANCOUVER, BC / ACCESSWIRE / June 5, 2023 / Gemina Laboratories Ltd. (CSE:GLAB)(FRA:8I7), a specialist in fast, affordable, and accurate diagnostic tests, is delighted to announce significant technical results from its collaboration with ReadyGo Diagnostics Ltd. ("ReadyGo"), an isothermal molecular diagnostics developer based in Bath, UK. This represents the first step of Gemina's move into molecular diagnostics adding further diagnostic capability to compliment our lateral flow programme.

Resulting from a collaboration which began in January 2023, Gemina and ReadyGo are proud to announce the successful feasibility of detecting Mycobacterium Tuberculosis ("MTB") in a saliva matrix using the ReadyGo GEO platform. This breakthrough in MTB detection paves the way for affordable testing which will have the potential to significantly impact MTB eradication efforts in countries such as India, Indonesia, and other affected regions worldwide.

The feasibility of utilizing saliva as a sample for the detection of Mycobacterium tuberculosis through a molecular diagnostic test has been successfully demonstrated.

MTB, commonly referred to as "Tuberculosis", is a highly infectious airborne disease caused by bacteria that affects the lungs, and was responsible for more than 10 million global infections in 2021, causing 1.6 million deaths. Alarmingly, an estimated 4 million infections (2 out of every 5 cases) remain undiagnosed and untreated, hampering disease control efforts. Diagnosis in low- to middle-income countries, where MTB is most prevalent, typically relies on smear microscopy using sputum samples. However, these tests have significant limitations, particularly in remote areas and when diagnosing certain patient populations such as children and the elderly, who struggle to produce sputum.

Consequently, the diagnosis of MTB presents a serious and complex healthcare challenge. The World Health Organisation has recommended the use of molecular diagnostic tests that can accommodate alternative sample types like saliva, thereby enhancing testing accessibility.

The Gemina and ReadyGo partnership will now progress to full product development, utilizing the GEO platform. The aim is to launch an MTB Screening Test in 2024, capable of replacing smear microscopy with a straightforward saliva sample. This innovative solution will provide results within 30 minutes, anywhere, at an affordable cost. Following the successful feasibility stage, the team anticipates introducing a compact laboratory instrument retailing for less than $1000, with a per-test cost of $5, enabling field testing near patients.