cobas® PIK3CA Mutation Test

cobas® PIK3CA Mutation Test
Accurate PIK3CA detection in advanced or metastatic breast cancer
Broad mutation coverage. Greater clinical insights.

 

The cobas® PIK3CA Mutation Test is a highly sensitive, real-time polymerase chain reaction (PCR) test for the qualitative detection and identification of PIK3CA mutations in patients with advanced or metastatic breast cancer. The cobas® PIK3CA Mutation Test detects 17 mutations in exons 2, 5, 8, 10, and 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET).

 

Key features and benefits

 

  • Detection of 17 PIK3CA mutations with > 94% coverage in breast cancer
  • High analytical sensitivity with a LoD of 0.7% to 3.5% mutation level*
  • Repeatability of > 99%
  • Clinical reproducibility of > 99%
  • 100% concordance with NGS
  • Automated results reporting in < 8 hours

 *variant dependent

Accurate and insightful icon
Accurate and insightful
high analytical sensitivity
High sensitivity and reproducibility
fast time to results icon
Fast time-to-results
Small sample input icon
Small sample input
Unlike other PCR PIK3CA IVD assays on-market today,

the cobas® PIK3CA Mutation Test provides greater than 94% coverage in breast cancer with the detection of 17 PIK3CA mutations, including all 11 that are considered clinically actionable.2 The broad mutation coverage of the cobas® PIK3CA Mutation Test is unmatched - providing valuable information of clinically actionable mutations, as well as additional insights into other relevant PIK3CA mutations.

High sensitivity and reproducibility

The cobas® PIK3CA Mutation Test detects PIK3CA mutations with a limit of detection (LoD) as low as 0.7%. Over multiple specimens, reagent lots, operators and days, the cobas® PIK3CA Mutation Test has demonstrated repeatability of 99.7%, clinical reproducibility of > 99%, and 100% concordance with next-generation sequencing (NGS). Using Roche PCR on the trusted cobas z 480 Analyzer ensures high sensitivity and quality results.

Automated results in less than 8 hours

From sample to analysis and insights, the cobas® PIK3CA Mutation Test provides accurate, reliable results in less than 8 hours. Using a simple, standardized workflow with the cobas z 480 Analyzer, laboratories have the flexibility to mix-batch sample types from different oncology assays and process up to 30 samples in a single run. The cobas® PIK3CA Mutation Test offers high quality, fast results, improving laboratory efficiency and allowing healthcare professionals to make confident treatment decisions sooner.

cobas PIK3CA workflow
Small sample input

Minimizing the amount of tissue used when testing is critical and potentially reduces the need for an additional biopsy-an already invasive procedure. The cobas® PIK3CA Mutation Test requires a single, 5μm FFPET section containing at least 10% tumor content, compared to other non-Roche PIK3CA tests that require twice the amount of tissue. The small sample input required for the cobas® PIK3CA Mutation Test helps preserve precious tissue from the patient, potentially reducing the need for a re-biopsy.

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. cobas® PIK3CA Mutation Test package insert
  2. COSMIC database v89