The global pandemic has increased focus and scrutiny on molecular diagnostic assay development, resulting in a need for assays that provide quick results while delivering expected performance and quality. The need for these types of assays in infectious disease diagnostics has become apparent on a wide scale. However, molecular diagnostic testing is also poised to grow in other areas such as genetic testing, prenatal testing, oncology, and pharmacogenomics over the next several years.

Growth in the amount of testing being done in these areas brings additional challenges due to several issues such as various sample types, presence of inhibitors, and low sample amounts—all of which contribute to potential poor results due to less-than-ideal amplification reactions.

This webinar will demonstrate how small changes to assay components (such as enzyme selection) can overcome many of these hurdles during development and significantly impact the overall quality and accuracy of an assay. The presentation will cover specific cases related to SARS-CoV-2 detection and highlight quality and manufacturing considerations crucial to developing a molecular assay for any target.

Topics covered

• Understand common challenges in molecular assay development and how to overcome them
• Discover various methods of enzyme development and key attributes contributing to improved molecular assay design
• Determine important considerations in quality and manufacturing standards for molecular assay development