Predictive, prognostic, and therapeutic response biomarkers across solid and hematologic malignancies.
| Biomarker Name | Testing Modality | Associated Malignancies | Targeted Therapeutic Agents (2026) |
|---|---|---|---|
| HER2 / ERBB2 (Amplification / Overexpression / Mutation) | IHC (0, 1+, 2+, 3+), FISH (Ratio >= 2.0), NGS | Breast, Gastric/GEJ, Colorectal, NSCLC | Trastuzumab, Pertuzumab, T-DXd (Enhertu), T-DM1, Tucatinib |
| EGFR (Exon 19 del, L858R, T790M, Exon 20 ins) | Real-time PCR, Targeted NGS, ctDNA Liquid Biopsy | Non-Small Cell Lung Cancer (NSCLC) | Osimertinib, Amivantamab + Lazertinib, Afatinib |
| ALK & ROS1 Fusions | Break-apart FISH, RNA Sequencing NGS, IHC (D5F3) | NSCLC, Inflammatory Myofibroblastic Tumor | Alectinib, Brigatinib, Lorlatinib, Entrectinib |
| KRAS G12C Mutation | Allele-Specific PCR, Targeted NGS | NSCLC (13%), Colorectal (3%), Pancreatic (1%) | Sotorasib (Lumakras), Adagrasib (Krazati) |
| BRAF V600E / V600K Mutation | Cobas PCR, VE1 IHC, Targeted NGS | Melanoma, Colorectal, NSCLC, Thyroid (Anaplastic) | Dabrafenib + Trametinib, Encorafenib + Cetuximab |
| MSI-H / dMMR (MLH1, MSH2, MSH6, PMS2) | IHC (Loss of Nuclear Expression), PCR MSI Panel, NGS | Colorectal, Endometrial, Gastric, Pancreatic (Agnostic) | Pembrolizumab, Dostarlimab, Nivolumab + Ipilimumab |
| PD-L1 Expression (TPS / CPS / IC) | IHC 22C3, 28-8, SP263, SP142 Assays | NSCLC, TNBC, Bladder, Head & Neck, Gastric, Cervical | Pembrolizumab, Nivolumab, Atezolizumab, Durvalumab |
| BRCA1 / BRCA2 (Germline / Somatic HRD) | Germline blood sequencing, Myriad myChoice HRD | Ovarian, Breast, Pancreatic, Prostate | Olaparib (Lynparza), Niraparib (Zejula), Talazoparib |