Monitoring mutations in HR+/HER2- advanced breast cancers

In HR+/HER2- advanced breast cancers, gene mutations in the ESR1 gene ligand binding domain (LBD) can cause treatment resistance to aromatase inhibitors. Physicians can monitor this mutation using a simple blood test, the GeneStrat ESR1 test, which helps them determine if the cancer is progressing or becoming resistant to therapy. The comprehensive, highly sensitive, and NYS CLEP-approved GeneStrat ESR1 test can be conducted as often as every other month to enable clinicians to more quickly adapt patient care more efficiently for a more personalized and effective treatment pathway. Identifying these mutations is important for improving patient survival. This type of blood test is now a preferred diagnostics methodology and is included in the National Comprehensive Cancer Network (NCCN) Guidelines. The GeneStrat ESR1 test can detect 11 of the most prevalent ESR1 variants in the LBD using Droplet Digital™ PCR (ddPCR™)technology. The test is designed to detect the respective ESR1 variants at high sensitivity in plasma-derived cfDNA. NYS CLEP approval for GeneStrat ESR1 was granted on March 12, 2026.

Note: Droplet Digital and ddPCR are trademarks of Bio-Rad Laboratories, Inc.