On December 15, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the launch of the cobas PIK3CA Mutation Test for patients with advanced or metastatic breast cancer (Press release, Hoffmann-La Roche, DEC 15, 2020, View Source [SID1234572852]). Previously only available as research use only (RUO), this in vitro diagnostic (IVD) test is now available in countries accepting the CE mark.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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.