ESR1 Reference Set 1% AF cfDNA
The ESR1 reference set 1% AF cfDNA is specifically designed as quality control material for lab-developed tests (LDTs) and CE-IVD assays targeting ESR1 mutations in cell-free DNA (cfDNA). The included mutations were carefully reviewed and endorsed by experts and ESR1 test developers. ESR1 mutations have been identified in 11%–55% of estrogen receptor-positive metastatic breast cancer patients treated with aromatase inhibitors, based on several retrospective studies. This reference set serves as a reliable quality control for ESR1 mutation assays at the cfDNA level.
Quote-based, no public pricing. Add to your quote and our specialists put together a proposal with the right documentation, typically within 24 hours.
This kit in detail
- For assessing test accuracy
- Verifying analytical sensitivity and specificity
- Monitoring reproducibility
- Validating new batches and reagents
- Ensuring quality assurance
- Troubleshooting errors
The ESR1 reference set 1% AF cfDNA is specifically developed as a quality control material for both lab-developed tests (LDTs) and CE-IVD labeled assays, focusing on ESR1 mutations in cell-free DNA (cfDNA). This set provides a reliable standard for ensuring accuracy in ESR1 mutation assays. The selection of mutations was thoroughly reviewed and endorsed by leading experts in the field, along with developers of ESR1 testing protocols, ensuring its relevance and quality.
ESR1 mutations have been reported in approximately 11%–55% of estrogen receptor-positive metastatic breast cancer patients treated with aromatase inhibitors, according to several retrospective cohort studies. The ESR1 reference set supports laboratories in validating their assays at the cfDNA level, helping to maintain consistency and reliability in ESR1 mutation testing.
- ESR1 Reference Set 1% AF cfDNA
This product is suited for PCR and/or Next Generation Sequencing (NGS) assays and is ready to use.
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Frequently paired with this kit
Other assays and instruments lab teams add alongside the ESR1 Reference Set 1% AF cfDNA.
EGFR-Multiplex 0.1% AF cfDNA in Plasma
Add this kit to your quote
Tell us the platforms and throughput you’re planning for and our specialists will put together a clear proposal with the right documentation, no public pricing, just a considered answer.
