FoundationOne CDx
A comprehensive genomic profiling assay used as an FDA-approved companion diagnostic to identify actionable genomic alterations across multiple solid tumors.
Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.
Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.
About this test
FoundationOne CDx is an in vitro diagnostic test that uses next-generation sequencing to analyze genomic alterations in solid tumor tissue. The assay is designed to detect clinically relevant substitutions, insertions and deletions, copy number alterations, and gene rearrangements across a broad panel of cancer-related genes.
Where this test fits
| Indication | Biomarker | Biomarker details | Therapy (Select a therapy to open its FDA-approved testing pathway) |
|---|---|---|---|
| Breast Cancer | ERBB2 (HER2) | gene amplification | HERCEPTIN, KADCYLA, PERJETA |
| PIK3CA | AKT1/PTEN alterations | TRUQAP + FASLODEX | |
| C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y | PIQRAY | ||
| Cholangiocarcinoma | FGFR2 | fusions and select rearrangements | PEMAZYRE |
| Colorectal Cancer (CRC) | KRAS | KRAS wild-type (absence of mutations in codons 12 and 13) | ERBITUX |
| KRAS and NRAS | wild-type (absence of mutations in exons 2, 3 and 4) | VECTIBIX | |
| Low-Grade Glioma | BRAF | V600 and BRAF fusions | OJEMDA |
| Melanoma | BRAF | V600 | TECENTRIQ + COTELLIC + ZELBORAF |
| V600E | TAFINLAR, ZELBORAF | ||
| V600E and V600K | BRAFTOVI + MEKTOVI, COTELLIC + ZELBORAF, MEKINIST, TAFINLAR + MEKINIST | ||
| Metastatic Castrate Resistant Prostate Cancer (mCRPC) | BRCA1 and BRCA2 | alterations (including mutations) | LYNPARZA + ZYTIGA |
| Homologous recombination repair (HRR) genes | BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D and RAD54L alterations | LYNPARZA | |
| Non-Small Cell Lung Cancer (NSCLC) | ALK | gene rearrangements | ALECENSA, ALUNBRIG, XALKORI, ZYKADIA |
| BRAF | V600E | BRAFTOVI + MEKTOVI, TAFINLAR + MEKINIST | |
| EGFR (HER1) | Exon 19 deletion or exon 21 L858R substitution mutation | GILOTRIF, IRESSA, LAZCLUZE + RYBREVANT, TAGRISSO, TARCEVA, VIZIMPRO | |
| T790M | TAGRISSO | ||
| MET | single nucleotide variants and indels that lead to MET exon 14 skipping | TABRECTA | |
| ROS1 | fusions | ROZLYTREK | |
| Ovarian Cancer | BRCA1 and BRCA2 | alterations (including mutations) | LYNPARZA |
| Prostate Cancer | BRCA1 and BRCA2 | alterations (including mutations) | AKEEGA |
| Solid Tumors | MSI-High | Microsatellite instability-High | KEYTRUDA |
| NTRK1, NTRK2 and NTRK3 | fusions | ROZLYTREK, VITRAKVI | |
| RET | fusions | RETEVMO | |
| TMB | TMB ≥ 10 mutations per megabase | KEYTRUDA |
Performing lab
Boston Lab (22D2027531)
At Foundation Medicine, our mission is to transform lives in cancer and beyond. We strive to provide multi-modal precision diagnostic solutions to transform cancer care throughout a patient’s experience, from pre-diagnosis to ongoing management and monitoring. Leveraging our vast knowledge of precision medicine, we partner with biopharmaceutical companies to accelerate the development of new personalized therapies in cancer and in a range of other diseases. For more information, visit us at www.FoundationMedicine.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.
Order this test
If your organization is connected to Casandra, you can place an electronic order forFoundationOne CDx directly from your existing workflow.
Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.