cobas® PIK3CA Mutation Test

cobas® PIK3CA Mutation Test

Real-time PCR detection of PIK3CA mutations in exons 1, 4, 7, 9 and 20.

The cobas® PIK3CA Mutation Test* is a real-time PCR test for the qualitative detection and identification of mutations in exons 1, 4, 7, 9 and 20 of the Phosphatidylinositol-3-kinase catalytic subunit alpha isoform (PI3KCA) gene in DNA derived from formalin-fixed paraffin-embedded tissue (FFPET).

Key benefits


  • The cobas® PIK3CA Mutation Test is more sensitive and specific in the detection of PIK3CA mutations than Sanger sequencing.1
  • PIK3CA test results can be obtained from a single, 5μm FFPET section with >10% tumor.
  • The cobas® PIK3CA Mutation Test can be performed in <8 hours.
  • Liquid, ready-to-use reagents are provided in the test kit to increase laboratory efficiency.
  • The test kits have an 18 month shelf life from date of manufacture.
  • Automated result interpretation and test reporting provides consistent, objective and reproducible results.
  • Has been validated in FFPET samples and can reliably detect PIK3CA mutations in exons 9 and 20 with ≥5% mutation level.
  • A total of 20 replicates of 5% mutant plasmid blends for each of the 17 mutations were tested, and in all cases the cobas® PIK3CA Mutation Test achieved a >95% hit rate.
  • Has demonstrated a 99.5% repeatability over multiple specimens, reagent lots, operators, instruments and days.2

Intended use

*For research use only. Not for use in diagnostic procedures.

Registration status

Research Use Only

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.


  1. cobas® PIK3CA Mutation Test Package Insert
  2. Based upon data on file