cobas® PIK3CA Mutation Test

cobas® PIK3CA Mutation Test

Real-time PCR test for the detection of PIK3CA mutations in patients with metastatic breast cancer

The cobas® PIK3CA Mutation Test (CE-IVD) is a real-time polymerase chain reaction (PCR) test used to identify patients with advanced or metastatic breast cancer whose tumors harbor phosphoinositide 3-kinase, catalytic, alpha subunit (PIK3CA) mutations. It is intended for the qualitative detection and identification of 17 mutations in exons 2, 5, 8, 10, and 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolation from formalin-fixed paraffin-embedded tumor tissue (FFPET).1,2

Each kit comes with liquid, ready-to-use reagents for increased laboratory efficiency, with the ability to process up to 30 samples per run.* Specimens are processed using the cobas® DNA Sample Preparation Kit3 to isolate genomic DNA from FFPET human specimens. Following DNA isolation, mutation detection is achieved through PCR analysis using the cobas z 480 Analyzer for automated amplification and detection.

Features and benefits2

  • High sensitivity of 0.7% to 3.5% mutation level (variant-dependent)
  • Repeatability of 99.7% demonstrated over multiple specimens, reagent lots, operators, and days
  • Clinical reproducibility of >99%
  • Sample input from a single, 5μm FFPET section with >10% tumor
  • Automated results reporting in < 8 hours
  • Flexible throughput to process 1-30 samples per run*

* >24 samples will require 2 kits

Intended use

Intended use

The cobas® PIK3CA Mutation Test (CE-IVD) is a real-time PCR test for the qualitative detection and identification of 17 mutations in exons 2, 5, 8, 10 and 21 in the gene encoding the catalytic subunit of phosphoinositide 3-kinase (PIK3CA) in DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET). The cobas® PIK3CA Mutation Test is intended for the identification of patients with metastatic breast cancer whose tumors harbor these mutations. Mutation detection is achieved through PCR analysis using the cobas z 480 Analyzer.

Registration status

CE-IVD

References

  1. Lambert, A et al, Pathology & Oncology Research (2019) 25:1117–1123
  2. cobas PIK3CA Mutation Test package insert
  3. cobas DNA Sample Preparation Kit package insert