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Drug Hunter - drug analyzer for in situ quantitative analysis of illegal drugs in oral fluid

Periodic Reporting for period 1 - Drug Hunter (Drug Hunter - drug analyzer for in situ quantitative analysis of illegal drugs in oral fluid)

Periodo di rendicontazione: 2023-07-01 al 2024-06-30

The Drug Hunter project, led by SafePAS Ltd., was conceived in response to a critical gap in the market for precise, on-site illegal drug testing. The rising prevalence of drug misuse across Europe, coupled with the limitations of existing drug testing methods, highlighted an urgent need for a solution that could provide reliable, immediate results in various settings, including roadside testing and public events. Traditional drug testing methods often involve delays and logistical challenges, particularly when samples need to be sent to laboratories for analysis. These challenges can undermine law enforcement efforts and public safety measures.

To address these issues, the project aimed to develop and expand the market reach of the Drug Hunter analyzer, an innovative device designed for rapid and accurate drug detection. Complement to Drug Hunter analyzer innovation is the SALIKIT, a compliant drug testing kit that meets rigorous bioanalytical method requirements, enabling secure and effective sample collection and treatment in the field. The project sought to establish a robust network of distributors, business partners, and customers across Europe. By validating the needs of these customers and aligning the product with relevant regulations, the project aimed to ensure that the Drug Hunter analyzer could be effectively deployed where it is most needed.

The expected impact of the project is significant. By providing law enforcement agencies, healthcare providers, and event organizers with a reliable tool for on-site drug testing, the Drug Hunter analyzer has the potential to enhance public safety and streamline drug detection processes. The rigorous testing and validation processes carried out during the project, including field tests at roadside checks and music festivals, ensured that the product is both effective and user-friendly, thereby increasing its adoption potential.

Moreover, the project not only focused on the technological aspects but also integrated a comprehensive business strategy to support its market introduction and growth. This included updating the business model, refining financial projections, and developing targeted marketing and sales strategies. By securing distributor agreements in multiple countries and establishing partnerships in diverse markets, the project laid a solid foundation for broader market expansion.
During the project, SafePAS Ltd. and its partners, undertook extensive technical and scientific efforts to advance the Drug Hunter analyzer's development, validation, and regulatory alignment. The project focused on rigorous pre-clinical studies, validating the device according to the ICH M10 guidelines across critical parameters such as selectivity, accuracy, and stability, ensuring it met international bioanalytical standards. Simultaneously, the team developed a plan to align the hardware and software with regulatory and client requirements, assessing compliance with standards like ISO 13485 and ISO 14971. Feedback from partners was actively incorporated, leading to enhancements in forensic applications, threshold adjustments, and device usability. By the project's conclusion, the Drug Hunter had successfully passed validation tests, confirming its reliability and positioning it for broader adoption in forensic settings.
During the project, SafePAS successfully scaled up its business readiness level by expanding its network of distributors, partners, and customers across key EU markets. Through active participation in international events and direct engagement with industry competitors and stakeholders, SafePAS positioned itself strategically within the competitive landscape of drug testing solutions. The dissemination activities, including participation in the ROADPOL International Conference, Europol Excellence Awards, and leading startup events, were instrumental in raising awareness of the Drug Hunter analyzer, building strategic relationships, and enhancing market visibility.

The market research and regulatory analysis conducted by SafePAS provided a comprehensive understanding of the drug testing landscape in targeted EU countries. This analysis was critical for validating the business model, refining sales and marketing strategies, and ensuring compliance with legal and regulatory requirements. To ensure continued success, further research and demonstration of the product's capabilities in real-world settings are needed. Access to additional markets and finance will be crucial for scaling up production and distribution, while IPR support and internationalization efforts will help protect and expand the product's reach globally. A supportive regulatory and standardization framework will also be key to ensuring long-term compliance and market adoption.
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