An open-source molecular diagnostic platform approach for outbreak and epidemic preparedness

Area of Science:

• Global Health
• Molecular Diagnostics
• Open-Source Development

Background:

• Traditional diagnostic development for outbreak pathogens is reactive and disease-specific.
• A proactive, flexible approach is needed for epidemic preparedness, particularly for resource-constrained settings.
• The World Health Organization Research and Development Blueprint prioritizes diverse outbreak pathogens.

Purpose of the Study:

• To present the benefits and challenges of an open-source business model for co-developing molecular diagnostic tests.
• To address the need for sustainable development of high-quality diagnostic products for epidemics in low- and middle-income countries.
• To leverage and de-risk the diagnostic development process for decentralized settings.

Main Methods:

• Identification of key outbreak pathogens requiring high-infrastructure laboratories.
• Comparison of in-country installed platforms for potential diagnostic menu expansion.
• Analysis of strengths and challenges for platform and assay developers within an open-source framework.

Main Results:

• The open-source model addresses challenges in detecting outbreak-prone pathogens in low- and middle-income countries.
• Development and deployment risks are reduced, supporting effective outbreak response.
• Diagnostic capacity is strengthened, and a viable market for product developers is created.

Conclusions:

• A collaborative, open-source approach to molecular diagnostics can improve outbreak preparedness.
• Encourages stakeholders to consider co-development partnerships for enhanced epidemic/pandemic response.
• Facilitates wider access to critical molecular diagnostic tests in diverse settings.