Implementation

Production:

Our production strategy is based on licensing our technology to established diagnostic manufacturers, enabling us to leverage their infrastructure, expertise, and global distribution networks. Prior to production, we will focus on research and development, with continuous testing and refinement throughout multiple engineering cycles. A primary goal will be to enhance test specificity as new biomarker research becomes available. Once our product fully meets all criteria, we will engage in production partnerships. This approach reduces the need for substantial capital investment in internal facilities, thereby lowering financial risk and enabling rapid scaling.

Licensing agreements will ensure our intellectual property is protected while allowing manufacturers to produce the test at scale in compliance with stringent quality standards. Furthermore, licensing generates a sustainable revenue stream through royalties, providing financial stability and supporting ongoing innovation and pipeline expansion. This strategy also offers flexibility, allowing us to partner with manufacturers in various regions and adapt production and distribution to local requirements. Ultimately, licensing enables us to focus on innovation, clinical validation, and expanding our pipeline, while trusted partners manage large-scale manufacturing and logistics, accelerating the widespread availability of our test.

Validation:

Before distributing the test product, we need to implement a validation protocol. This will involve sampling products from the manufacturing line to ensure they meet all necessary requirements and function as intended. Additionally, during the initial stages of product development and validation, we will conduct clinical trials to confirm that our test functions effectively not only in the laboratory but also in real-world scenarios.

In order to test the efficacy of any detection system these three criteria should be met:

• The system does not produce a signal when there is no biomarker
• The system does not produce a signal when there is a similar but wrong biomarker
• The system produces a detectable signal when the correct biomarker is present

To test these three criteria, the following steps will be carried out:

1. Test the system's expression in the absence of miRNA (also referred to as leakage testing). This will help determine if the system is suitable for further experiments. Some leakage is expected, but it should be minimal (barely visible to the naked eye) to avoid false positives.
2. Once the system is confirmed to exhibit minimal leakage, proceed to test it with a non-target miRNA that is up to 80% similar to the intended biomarker. In this case, expect some level of signal expression, but it should be sufficiently low to prevent a false positive response.
3. Finally, the system is tested with the target miRNA to confirm that it can generate a clear signal when the target molecule is present.

In our product, the mRFP reporter gene serves as our signal, producing a deep red color upon transcription. We quantify all tests using visible light spectroscopy.

Storage:

Our diagnostic test kits will be stored at normal room temperature in a clean, dry environment to ensure their stability and reliability. They will remain in their original packaging, which protects them from light, dust, and minor physical damage during storage and handling. This simple storage requirement eliminates the need for costly cold-chain logistics or specialised facilities, making the tests highly practical for use in low-resource and urban settings. Keeping the tests in their protective packaging until use, further ensures ease of distribution and preservation of product quality. Our test has a shelf life of three months.

Upscaling:

Upscaling for our business will focus on transitioning from small-scale prototype production to mass manufacturing while maintaining affordability, quality, and accessibility. This will involve moving from lab-based assembly to standardised, automated production processes that comply with international quality standards such as ISO 13485 and Good Manufacturing Practices (GMP). By partnering with experienced manufacturers through licensing agreements, we can scale quickly without the heavy upfront investment of building our own facilities. To ensure supply chain resilience, we intend to secure reliable sources of raw materials, including microalgae-based polylactic acid (PLA) for cassettes and key reagents, and establish regional manufacturing hubs to reduce costs and improve distribution efficiency. Simultaneously, we will invest in continuous process optimisation to lower unit costs as volumes increase, keeping our tests competitively priced. This scalable model supports rapid growth in the TB diagnostics market and establishes a foundation for adapting our platform to other diseases, increasing both our reach and long-term commercial potential.

However, we anticipate several challenges in upscaling. Supply chain vulnerabilities, such as reagent shortages or fluctuations in microalgae-based PLA availability, will be managed through diversified suppliers and stockpiling strategies. Regulatory hurdles across different jurisdictions may extend timelines, so we will engage early with regulators and seek certifications like WHO prequalification to facilitate global approvals. Maintaining consistent quality at scale is a potential risk, which we will address through strict quality management systems and regular audits of our manufacturing partners. By proactively addressing these barriers, we can ensure upscaling enhances both our commercial success and global health impact.