Roche launches cobas PIK3CA Mutation Test for patients with advanced or metastatic breast cancer in countries accepting the CE mark

• This genetic test identifies mutations in the PIK3CA gene that can cause cells to grow uncontrollably, which may lead to cancer
• PIK3CA is the most commonly mutated gene in advanced or metastatic breast cancer, with nearly 40 percent of patients harbouring a mutation in this gene¹
• The cobas PIK3CA Mutation Test is a PCR-based test that detects PIK3CA mutations in patients with metastatic breast cancer to help identify those most likely to benefit from approved therapy²
  
  

Basel, 15 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas PIK3CA Mutation Test for patients with advanced or metastatic breast cancer. Previously only available as research use only (RUO), this in vitro diagnostic (IVD) test is now available in countries accepting the CE mark.

“Nearly two million women are diagnosed with breast cancer each year, and an estimated half a million could harbour a PIK3CA mutation.^3,4 If correctly identified, some of these women may benefit from targeted therapy,” said Thomas Schinecker, CEO Roche Diagnostics. “We are pleased to offer the cobas PIK3CA Mutation Test CE-IVD, enabling clinicians to accurately and quickly manage their breast cancer patients.”

In advanced or metastatic breast cancer, PIK3CA mutations are associated with tumour growth, resistance to endocrine treatment, and a poor overall prognosis. The cobas PIK3CA Mutation Test detects 17 mutations in the PIK3CA gene and can help clinicians identify patients who may benefit from phosphoinositide 3-kinase (PI3K) targeted therapy as supported by medical guidelines.^5,6

About the cobas PIK3CA Mutation Test
The cobas PIK3CA Mutation Test 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 PIK3CA in DNA isolated from formalin-fixed paraffin-embedded tissue (FFPET). The cobas PIK3CA Mutation Test is intended to identify patients with metastatic breast cancer whose tumours harbour these mutations.

The cobas PIK3CA Mutation Test provides automated results reporting, with flexible throughput to process up to 30 samples per run on the widely available cobas z 480 Analyzer. Specimens are processed using the cobas DNA Sample Preparation Kit to isolate genomic DNA from FFPET human specimens. Using a standardised workflow, the cobas PIK3CA Mutation Test provides fast time-to-results in under eight hours.