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.

"I'm delighted to be seeing such significant results, so quickly, from our partnership with ReadyGo Diagnostics," stated 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."

Ben Cobb, CEO of ReadyGo Diagnostics added, "I'm thrilled about our continued progress and collaboration with Gemina in establishing a tuberculosis diagnostic platform using saliva as the primary sample. 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."

On Behalf of the Board of Directors

Brian FirthCEO

Gemina Laboratories Ltd.

About Gemina Laboratories Ltd.

Gemina Labs is a biosensor and diagnostic company with a transformative, patented, proprietary chemistry that powers next-generation testing platforms for a wide range of pathogens that affect human health and wellness. Our technology drives testing platforms that are fast, affordable and accurate, and easily self-administered. Our development pipeline includes platforms for the rapid testing of COVID-19, influenza and other viruses. Additional information on the Company can be found at www.geminalabs.com.

About ReadyGo Diagnostics Ltd.

ReadyGo Diagnostics is a rapidly growing diagnostics company that designs, develops and commercialises novel sample collection devices and diagnostic platforms. Our proprietary technology molecular diagnostic platform, GEO™, permits low cost decentralised testing in under 30 minutes. Our Sampler transforms diagnostic testing by elegantly combining sample collection and processing into a single, user-friendly disposable and provides optimal and reproducible samples for testing using molecular, biochemical and lateral flow tests. For more information, please refer to the website: www.readygotest.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this Release.

Forward Looking Statements

This news release includes forward-looking information and statements, which may include, but are not limited to, information and statements regarding or inferring the future business, operations, financial performance, prospects, and other plans, intentions, expectations, estimates, and beliefs of the Company. Such statements include statements regarding the anticipated terms of any proposed transaction or engagement. Information and statements which are not purely historical fact are forward-looking statements. Forward-looking information and statements involve and are subject to assumptions and known and unknown risks, uncertainties, and other factors which may cause actual events, results, performance, or achievements of the Company to be materially different from future events, results, performance, and achievements expressed or implied by forward-looking information and statements herein. Although the Company believes that any forward-looking information and statements herein are reasonable, in light of the use of assumptions and the significant risks and uncertainties inherent in such information and statements, there can be no assurance that any such forward-looking information and statements will prove to be accurate, and accordingly readers are advised to rely on their own evaluation of such risks and uncertainties and should not place undue reliance upon such forward-looking information and statements. Furthermore, the Company is presently unable to fully quantify the impact that the Covid-19 pandemic will have on its operations and recognizes that certain eventualities may affect planned or assumed performance moving forward. As such, any forward-looking information and statements herein are made as of the date hereof, and except as required by applicable laws, the Company assumes no obligation and disclaims any intention to update or revise any forward-looking information and statements herein or to update the reasons that actual events or results could or do differ from those projected in any forward looking information and statements herein, whether as a result of new information, future events or results, or otherwise, except as required by applicable laws.

For more information regrading the Company, please contact:

Gemina Laboratories LtdBrian Firth, Chief Executive OfficerEmail: [email protected]

ReadyGo Diagnostics LtdBen Cobb, Chief Executive OfficerBen Reed, Chief Commercial OfficerEmail: [email protected]

SOURCE: Gemina Laboratories Ltd.

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