COVID-19’s devastating impact on the world has shone a spotlight on the importance of effective diagnostic testing for respiratory illnesses.
Canada and UK–based company Gemina Laboratories (CSE:GLAB) is progressing multiple Point-of-Care (PoC) diagnostic products for respiratory diseases, utilizing proprietary chemistry that the company calls “one of the most significant developments in rapid in vitro diagnostics since its invention.”
“Our technologies enable tests to be less expensive, more sensitive and more environmentally friendly,” Brian Firth, Gemina Laboratories Chief Executive Officer, tells Canadian Securities Exchange Magazine.
Firth, a 35-year veteran of the PoC diagnostics industry, spent nearly eight years at Swiss Precision Diagnostics, producer of the Clearblue-branded pregnancy test, first as managing director of its UK subsidiary and later as chief operating officer of the parent company.
He has also owned a health tech advisory practice, with clients that included Agfa, Johnson & Johnson and AkzoNobel.
Gemina’s CEO explains that the company’s technologies fit into two groups: one that improves lateral flow tests and another that improves molecular testing.
Lateral flow technology, which is commonly used in home pregnancy tests, has traditionally been subject to poor accuracy compared to laboratory equipment due to inefficient deposition of the antibody, or “catcher”, in which as little as 30% of the antibody is effective.
Gemina’s proprietary chemistry is a surface chemistry binder that acts like a stand for the catcher, ensuring that all catchers are oriented in the optimum position, which increases both stickiness and efficiency so that 100% of the catcher is effective.
The company’s lateral flow improvements enable the same sensitivity as traditional tests but with 75% less antibody usage, which is one of the major cost advantages.
Its technologies also enable tests to be built on paper, derived from plant cells contained in products such as cotton, wood and hemp, rather than using expensive and difficult-to-source nitrocellulose, which has been used for the nearly 40-year history of the lateral flow assay.
Developed in the 1800s, nitrocellulose is formed by treating cellulose with a mixture of nitric and sulfuric acids to produce a flammable compound that only degrades slowly in the environment, releasing nitric acid in the process.
The compound is well suited to lateral flow assay development due, in part, to the uniformity of the nitrocellulose pore structure and to the binding affinity between nitrocellulose and the antibodies used in the lateral flow immunoassay format.
Gemina’s technologies allow tests to be made efficiently on local manufacturing cells that can be built in any country, bringing true diagnostics access to even low-income countries.
The company’s molecular technologies, meanwhile, have enabled assays to be run on fully portable molecular diagnostic machines, which can detect tuberculosis (TB) in saliva, improving the screening for TB globally.
Its molecular technologies product will enter clinical trials in 2024 with the global launch expected in 2025.
Gemina’s testing breakthrough has the goal of creating affordable, rapid, lab-accurate PoC diagnostics in any environment, worldwide.
PoC is a market that has estimated compound annual growth of 7% and is expected to reach US$55.3 billion by 2030, according to Allied Market Research.
“Gemina will begin to generate regular revenues early in 2024 with breakeven coming in early 2025,” Firth says.
He noted the company has devised a multifaceted revenue strategy that encompasses traditional product distribution, technology licensing, franchised manufacturing and a promising new venture in the pharmacy channel.
Traditional product distribution will be used for tests Gemina develops and brings to market. The company will also license its technologies to large diagnostics companies to significantly improve their processes.
As well, Gemina will engage in franchised/distributed manufacturing where manufacturing cells are licensed to individual countries, enabling these nations to manufacture their own critical diagnostics. The company will further supply the key reagents (a substance or mixture for use in chemical analysis or other reactions) and components for the individual tests the countries create.
Finally, Gemina is currently developing a pharmacy revenue channel supporting the move internationally toward test-to-treat programs.
Firth says the company’s earliest revenues will come from licence deals that are currently in negotiations, with the first of these expected to be signed soon.
To help accelerate its licence deals and partnership opportunities, Gemina recently engaged global investment bank Stifel, which has extensive licensing experience across the life sciences sector, as its exclusive financial advisor.
The initial licence deals will be followed by product distribution agreements for Asia as well as franchise manufacturing deals that are anticipated to be signed by the end of 2024.
Gemina is targeting a 20% share of the respiratory test market within 10 years, with its first product expected to be launched in the European and African markets.
To finance its growth, Firth said the company is planning a private placement in the closing months of 2023 into early 2024 that should support its strategy through 2024.
Firth adds that the company is also seeing interest from several grant funds that will work with Gemina to secure appropriate non-dilutive funding.
And there are expectations that at some point during 2024, Gemina will use the upfront payment components of licence deals as another form of non-dilutive financing.
Looking ahead, Gemina’s CEO sees several upcoming catalysts that could help to boost corporate value.
Gemina anticipates signing its first significant licensing partnership by year’s end.
Within the next six months, the company expects to report positive pre-clinical results for its TB test, with full clinical results and the launch of the TB test targeted to occur sometime over the next year and a half.
As well, Gemina should announce the signing of distribution agreements for its molecular tests within the next year.
The company also anticipates launching its protein production facility toward the end of 2024, which will supply the increasing number of licensees expected to be signed.
Finally, along with Gemina’s first significant revenue in 2024, the company is gearing up for franchise bookings for local manufacturing facilities from multiple countries.
This story was featured in Canadian Securities Exchange Magazine.
Learn more about Gemina Laboratories at http://geminalabs.com/.