Droplex ESR1 Mutation Test

Detection of the 16 defined mutations within the catalytic a-subunit of the ESR1-Gene

Features

Breast cancer (BC) is the most common type of cancer and the second leading cause of death in women. Approximately 71 % of all breast cancer patients have a tumor of the ER+ and HER2 type. Up to 40 % of ER+/HER2 positive patients show ESR1 mutations in exons 5, 7, and 8, which are considered as the cause of resistance to standard endocrine therapy. Innovations in endocrine therapy are already showing significant treatment success in cases with activating ESR1 mutations.

The CE-IVD certified Droplex ESR1 Mutation Test detects 16 defined mutations within the ESR1 gene using Digital DropletTM technology.

Biomarkers

Exon 5: E380Q

Exon 7: S463P

Exon 8: V534E, L536P/R/Q/H, Y537S/C/N/H/D, D538G

Product specifications

  • Cat No.
  • CD009
  • Cancer type
  • Breast cancer
  • Regulatory status
  • CE-IVD
  • Compatible sample type
  • DNA from FFPE tissue, for RUO application: cfDNA from Plasma
  • Mutation variants
  • 16
  • Kit size/ reactions
  • 24 samples/kit (2 well-reactions/sample)
  • Platform
  • Digital DropletTM PCR

Resources

Instructions for Use / Handbooks
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Instructions for Use / Handbooks
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Safety Data Sheets / Non-Hazardous Statements
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Technical Information
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Ordering Information

Droplex ESR1 Mutation Test

Size: 24 samples/kit (2 well-reactions/sample)
Cat.No.: CD009
Status: CE-IVD

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