Table 1. F1CDx companion diagnostic claims.
| Tumor type | Biomarker(s) detected | Therapy |
|---|---|---|
| Pan-tumor | TMB ≥10 mutations per megabase | Keytruda® (pembrolizumab) |
| NTRK1/2/3 fusions | Vitrakvi® (larotrectinib) | |
| NSCLC | EGFR exon 19 deletions and EGFR exon 21 L858R alterations | Gilotrif® (afatinib), Iressa® (gefitinib), Tagrisso® (osimertinib), or Tarceva® (erlotinib) |
| EGFR exon 20 T790M alterations | Tagrisso® (osimertinib) | |
| ALK rearrangements | Alecensa® (alectinib), Alunbrig® (brigatinib), Xalkori® (crizotinib), or Zykadia® (ceritinib) | |
| BRAF V600E | Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) | |
| MET exon 14 skipping | Tabrecta™ (capmatinib) | |
| Breast cancer | ERBB2 (HER2) amplification | Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), or Perjeta® (pertuzumab) |
| PIK3CA C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y alterations | Piqray® (alpelisib) | |
| CRC | KRAS wild-type (absence of detectable mutations in codons 12 and 13) | Erbitux® (cetuximab) |
| KRAS wild-type (absence of detectable mutations in exons 2, 3, and 4) and NRAS wild type (absence of detectable mutations in exons 2, 3, and 4) | Vectibix® (panitumumab) | |
| Ovarian cancer | BRCA1/2 alterations | Lynparza® (olaparib) or Rubraca® (rucaparib) |
| Prostate cancer | HRR gene (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, and RAD54L) alterations | Lynparza® (olaparib) |
| Melanoma | BRAF V600E | Tafinlar® (dabrafenib) or |
| Zelboraf® (vemurafenib) | ||
| BRAF V600E and V600K | Mekinist® (trametinib) or Cotellic® (cobimetinib) in combination with Zelboraf® (vemurafenib) | |
| Cholangiocarcinoma | FGFR2 fusions and select rearrangements | Pemazyre™ (pemigatinib) |
| Truseltiq™ (infigratinib) |
CRC = colorectal cancer; HRR = homologous recombination repair; NSCLC = non-small cell lung cancer; TMB = tumor mutational burden.