cobas^® PIK3CA Mutation Test

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.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