# LeukoStrat CDx FLT3 Mutation Assay

Source: https://onco.cc/drugs/leukostrat-cdx-flt3/  
OnCo record `leukostrat-cdx-flt3` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The FDA-approved test that decides whether a person with acute myeloid leukaemia has a FLT3 mutation and so can be offered a FLT3 inhibitor.

## Summary

Invivoscribe's LeukoStrat CDx FLT3 Mutation Assay was approved on 28 April 2017 (PMA P160040) as the companion diagnostic for midostaurin in acute myeloid leukaemia. Supplements added gilteritinib (28 November 2018) and quizartinib (20 July 2023). Invivoscribe also runs the test in its own LabPMM clinical laboratories.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: LeukoStrat CDx FLT3
- Modality: PCR companion diagnostic test (FLT3 ITD and TKD mutations, blood or bone marrow)
- Mechanism: Detects FLT3 internal tandem duplications (ITD) and the tyrosine kinase domain (TKD) mutations at D835 and I836 in DNA from peripheral blood or bone marrow.
- Approvals: US 2017: Companion diagnostic for midostaurin in acute myeloid leukaemia (FLT3 ITD and TKD); US 2018: Companion diagnostic for gilteritinib; US 2023: Companion diagnostic for quizartinib

## Sources

- FDA PMA P160040: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160040
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools
- Invivoscribe: about us: https://invivoscribe.com/about-us/

## Connected records

- biomarkers: [FLT3-ITD (internal tandem duplication)](https://onco.cc/biomarkers/flt3-itd/), [FLT3-TKD (D835 and I836 tyrosine kinase domain mutations)](https://onco.cc/biomarkers/flt3-tkd/)
- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- targets: [FLT3](https://onco.cc/targets/flt3/)
- drugs: [Gilteritinib](https://onco.cc/drugs/gilteritinib/), [Midostaurin](https://onco.cc/drugs/midostaurin/), [Quizartinib](https://onco.cc/drugs/quizartinib/)
- companies: [Invivoscribe](https://onco.cc/companies/invivoscribe/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)

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