Table 2.

Laboratory Developed Test (LDT) assays approved by the FDA as companion diagnostic (CDx).

LDT CDx Assay	Platform/Technology
BRACAnalysis CDx (Myriad Genetic Laboratories)	PCR
KIT D816V Mutation Detection by PCR for Gleevec Eligibility (ARUP Laboratories)*	PCR
PDGFRB FISH for Gleevec Eligibility (ARUP Laboratories)*	FISH
FoundationFocus CDxBRCA Assay (Foundation Medicine)	NGS
FoundationOne CDx (Foundation Medicine)	NGS
LeukoStrat CDx FLT3 Mutation Assay (Invivoscribe Technologies)	PCR
Myriad myChoice CDx (Myriad Genetic Laboratories)	NGS
Guardant360 CDx (Guardant Health)	NGS
FoundationOne Liquid CDx (Foundation Medicine)	NGS

Abbreviations: FISH, fluorescence in situ hybridization; PCR, polymerase chain reaction; NGS, next generation sequencing.

^⁎Approved through a humanitarian device exemption.