cobas® PIK3CA Mutation Test

RUO For Research Use Only. Not for use in diagnostic procedures.
<b>cobas</b><sup>®</sup> 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 features

  • 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.


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


Detailed Specifications

Ordering Information

Compatible Instruments


    Technical Documents

    error errorMessage
    Sorry, we couldn't find the content you are looking for
    Please try again later