Diagnostic Application Notes
Adjusting Variant Allele Frequency (VAF) in ESR1 Control Kit
The ESR1 Control Kit includes synthetic DNA with clinically relevant ESR1 mutations at 1% VAF and a wild-type control, supporting assay performance and LoD studies. This application note outlines how to create lower-VAF samples using the kit and the cfgDNA Normal Female Standard Background to assess assay sensitivity.
Mobilizing Molecular Diagnostics for the Next Pandemic
This report summarizes a virtual round table discussion about the future of molecular diagnostics and strategies for deploying them effectively during the next pandemic.
How the FDA’s Rule on Laboratory-Developed Tests Could Impact the In Vitro Diagnostics Industry
This report summaries a virtual roundtable discussion in which experts discuss the FDA’s LDT rule, the challenges it presents to clinical laboratories, and how IVD vendors can help clinical labs navigate these challenges.