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Molecular diagnostics (MDx) is rapidly advancing, with a growing array of DNA- and RNA-based tests now available to physicians, pharmacists, geneticists, research scientists, and other healthcare professionals.

As labs work with human and microbial genes, test developers must comply with clinical guidelines and regulations. Both established companies and start-ups face challenges, including meeting regulatory standards, ensuring quality, and managing supply chain issues. Early planning and robust partnerships are key to overcoming these obstacles.

This essential guide explores these challenges through detailed case studies. It covers everything from early development and assay formulation, to supply chain security, offering expert insights on successfully bringing PCR, next-generation sequencing (NGS), and other nucleic acid-based diagnostic tests to market.

With the challenges faced at the peak of the COVID-19 pandemic still very fresh in the memory, delivering point-of-care testing with speed, convenience, and reliability remains a pressing need in primary care. A resurgence in other respiratory pathogens, including influenza A and B, has left no respite for urgent care centers, general practice, and pharmacies as their testing services remain under pressure. The development and implementation of a PCR platform that could produce results in just minutes rather than hours would therefore be transformative.

In this SelectScience® webinar, Andrew Anyakwo, Head of Reagent Development at LEX Diagnostics, will give a unique insight into how they have been able to achieve just that - developing a low-cost, point-of-care PCR test that aims to diagnose SARS-CoV-2 and Flu A/B in just 5 minutes with high sensitivity and specificity.

Key learning objectives

• Understand the challenges the rapid development of assays/devices presents, how they can be overcome, and what can be learned in the process
• Gain insight into how to deal with inhibitors
• Explore the benefits of partnering with a manufacturer to develop a solution with GMP at scale
• Discover how PCR can be improved upon to revolutionise point-of-care molecular diagnostics

Who should attend?

Assay developers and scientists working within the molecular diagnostics field.

Certificate of attendance

All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.

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