FoundationOne CDx Foundation1CDx

Synonyms

Allscripts (AEHR) Order Name

FoundationOne CDx

Sunrise Clinical Manager (SCM) Order Name

FoundationOne CDx

EPIC Order Name

FoundationOne CDx

Clinical Info

FoundationOne CDx is a qualitative next-generation sequencing tissue-based test for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens.

It is FDA-approved as a companion diagnostic to identify patients who may benefit from treatment with a specific list of therapies in accordance with the approved therapeutic product labeling.

Specimen Type

Tissue

Specimen Volume

Container

Formalin-fixed paraffin embedded (FFPE)

Collection Instructions

Transport Instructions

Specimen Stability

Methodology

Days Performed

Performing Laboratories

• Foundation Medicine

CPT

PDM

255199

Result Interpretation

Forms