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, but 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 a number of 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.
1. Demonstrate how lyo-ready enzymes can overcome many of these issues and provide a viable solution for assay development.
2. Discuss advantages of lyophilization compared to traditional methods.
3. Explain why the quality and manufacturing considerations are crucial when selecting a commercialization partner.