Verification of a Highly Sensitive, Circulating Cell-Free DNA and Exosomal RNA RT-qPCR Assay System to Monitor ESR1 Mutations from a Liquid Biopsy
Summary
- Mutations in the Estrogen Receptor 1 (ESR1) gene are the leading cause of treatment resistance in HR+ metastatic breast cancer (mBC). While ESR1 testing is currently recommended at progression, ongoing clinical trials are demonstrating the benefits of switching therapies once mutations are detected in blood, prior to overt progression. Broadly accessible blood based tests for ESR1 will be needed to support a paradigm shift to molecular monitoring in the mBC setting.
- The ExoLutionTM Plus cfDNA + exoRNA Isolation Kit* and QuantideX® qPCR ESR1 exoMutation Kit* combination includes reagents, consumables, and automated analysis software to reliably detect 11 ESR1 resistance mutations across 6 target codons on widely-used qPCR platforms.
- The ExoLution Plus cfDNA + exoRNA Isolation Kit* was developed to coisolate cell free DNA (cfDNA) and exosomal RNA (exoRNA) from 2-4 mL of filtered plasma.
- The Kit design was verified on cfDNA and exoRNA isolated from multiple collection tube types, linearized plasmids, and cell line conditioned media samples across multiple operators, storage conditions, qPCR platforms, plasma inputs, and kit lots, resulting in robust and precise assay
performance.
*For Research Use Only. Not for use in diagnostic procedures.