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).
- The cobas® PIK3CA Mutation Test is more sensitive and specific in the detection of PIK3CA mutations than Sanger sequencing.
- 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.1
- 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
*For research use only. Not for use in diagnostic procedures.
- cobas® PIK3CA Mutation Test package insert
- Based upon data on file