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Companion Diagnostics (CDx) | LeukoStrat® CDx FLT3 | Invivoscribe
Companion Diagnostics (CDx)2026-10-01T16:31:05-07:00
PRODUCTS

Companion Diagnostics (CDx)

CDx are in vitro diagnostic (IVD) tests used to identify biomarkers that help determine which patients are most likely to benefit from specific or combinatorial targeted therapies. They improve patient outcomes by transforming molecular marker data into actionable treatment decisions.

PRODUCTS

Companion Diagnostics
(CDx)

CDx enable the identification of biomarkers that indicate the patients most likely to benefit (or alternately not benefit) from specific or combinatorial targeted therapies. Their utilization enhances patient care and the potential for improved outcomes.

The LeukoStrat® CDx FLT3 Mutation Assay

The only globally standardized FLT3 companion diagnostic approved for all FLT3 tyrosine kinase inhibitors enabling targeted therapeutics in AML.

The LeukoStrat CDx FLT3 Mutation Assay is an IVD companion diagnostic to aid in the selection of acute myeloid leukemia (AML) patients eligible for treatment with midostaurin (US), gilteritinib fumarate (US, Japan, EU, Switzerland), or quizartinib hydrochloride (US, Japan, EU, Switzerland).

 

IVD CDx Kit Solution

Invivoscribe offers a complete solution for FLT3 Internal Tandem Duplication (ITD) and Tyrosine Kinase Domain (TKD) mutation detection, enabling laboratories and physicians to support patients with local access to high-quality diagnostic tests that improve treatment.

IVDR-certified Kit (EU) ⟶
FDA-approved Kit (US) ⟶
PMDA-approved Kit (JP) ⟶

The LeukoStrat® CDx FLT3 Mutation Assay

Intended to assist physicians in making treatment decisions for their AML patients with FLT3 mutations.

As the CDx to midostaurin (US, EU, Switzerland), gilteritinib fumarate (US, Japan, EU, Switzerland) and quizartinib hydrochloride (Japan), the LeukoStrat CDx FLT3 Mutation Assay is a globally standardized test validated for detection of genetic mutation in the FLT3 gene which is one of the most important driver mutations in AML.

IVD Kit Solution

A complete solution for FLT3 ITD & TKD detection, enabling laboratories and physicians to support patients with local access to high-quality, diagnostic tests that improve treatment.

K-412-0291 CE-IVD (EU) ⟶
K-412-0361 IVD (US) ⟶
K-412-0331 IVD (JP) ⟶
WHY IT MATTERS

While FLT3-targeted AML therapies are approved and may save lives, these tyrosine kinase inhibitor (TKI) therapies are available only by prescription following confirmation of FLT3 mutation with a validated test, such as the LeukoStrat CDx FLT3 Mutation Assay.

AML is the most common form of  acute leukemia in adults, and approximately 1 out of 3 diagnosed with AML are expected to have presence of FLT3 activating mutations.1

The presence of activating mutations in AML portends a poor prognosis, and some treatment regimens and targeted drug trials are only accessible to patients who test positive for the FLT3 mutation.1,2 A false negative FLT3 test result can have serious implications for the patient.

Due to the significant impact FLT3 testing may have on AML patient lives, the LeukoStrat CDx FLT3 Mutation Assay represents one of the most critically important biomarker tests for patients with AML.

WHEN TO TEST FOR FLT3 Mutations

NCCN, ELN and CAP Guidelines recommend FLT3 mutation testing to inform patient treatment decisions. 

FLT3 companion diagnostic testing is recommended for newly diagnosed AML patients, and at regular intervals thereafter because FLT3 mutation status may evolve over the course of the disease.6,7,8

WHAT IS A CDx

Companion Diagnostics (CDx) are in vitro diagnostic tests that serve as a primary standard of care in the area of personalized medicine.  Their utilization enhances patient care and the potential for improved outcomes.

CDx are critical molecular diagnostic tools enabling the identification of biomarkers that indicate the patients most likely to benefit from specific or combinatorial targeted therapies.

For cancer patients, this means a CDx can detect a biomarker predictive of how an individual’s cancer, based on underlying genetics or biology, will respond to a given treatment.

Screening patients for FLT3-ITD and FLT3-TKD mutations informs the selection of optimal biomarker-driven therapies. Equally important, they can spare patients who are unlikely to benefit from unnecessary therapies and their potential side effects.

THE SOLUTION FOR FLT3 TESTING

The LeukoStrat CDx FLT3 Mutation Assay is a validated PCR-based mutation assay for FLT3 ITD and FLT3 TKD detection with software-driven mutant identification, mutant to wild type signal ratio reporting, and clinical interpretation.

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based acute myeloid leukemia test targeting regions of the FLT3 gene to identify ITD and TKD (D835, I836) activation mutations in patient samples.

Automated software interprets data for FLT3 mutation status ensuring patients are above a significant clinical cut-off.

AML patients may be prescribed TKI therapy following confirmation of FLT3 mutations with a validated test, such as the LeukoStrat CDx FLT3 Mutation Assay5, which served as the companion diagnostic in the collective ADMIRAL, RATIFY and QuANTUM-R clinical trials, each respectively used in approvals of Xospata® (gilteritinib), Rydapt® (midostaurin), and Vanflyta® (quizartinib).

WHY FLT3 ITD and FLT3 TKD

FLT3 activation mutations (ITD, TKD) are an attractive drug target in AML.

Internal tandem duplications (ITD) and point mutations in the tyrosine kinase domain (TKD) of the FLT3 gene both result in constitutive auto-phosphorylation and activation of the FLT3 receptor, which may associate with AML disease.2

In recent years, management of AML disease improved with the development of TKIs that are now approved as targeted therapies for ITD and/or TKD mutations in the FLT3 gene.

The most prevalent and clinically significant type of FLT3 mutation is an ITD in and around the juxtamembrane domain of the receptor. FLT3-ITD are a heterogeneous type of mutation in location, size, and number and are characterized by an aggressive phenotype with high prevalence of relapse.3,4 Clinical studies have found FLT3-ITD mutations are associated with higher numbers of leukemic cells, increased incidence of relapse, and decreased overall survival.4

The second most common mutation type in the FLT3 gene is a TKD point mutation in the codon for an aspartate (D835) or an isoleucine (I836) residue located in the activation loop of the FLT3 protein. FLT3-TKD mutations are caused by nucleic acid substitutions and/or deletions that result in a change in the amino acid sequence in this highly conserved catalytic center.

REFERENCES
  1. Acute Myeloid Leukemia, Clinical Practice Guidelines in Oncology, (v.5.2026) National Comprehensive Cancer Network.
  2. Yamamoto, Y. et al., (2001). Activating mutation of D835 within the activation loop of FLT3 in human hematologic malignancies. Blood 97, 2434-2439.
  3. Bacher, U. et al., Blood. 2008; 111: 2527-2537
  4. Whitman, S.P. et al., Blood. 2010; 116: 3622-3626
  5. Levis, M. et al., Blood Adv. 2018; 2(8):825-831.
  6. Dillon, L. et al., JAMA. 2023; 329(9):745-755.
  7. Dillon, L. et al., JAMA Oncol. 2024; 10(8):1104-1110.

Partner with Invivoscribe for Companion Diagnostics

Precision oncology starts with trusted diagnostics. Invivoscribe’s validated companion diagnostics tests bring standardized molecular workflows to programs where accuracy drives every decision.

Request more information today to explore the LeukoStrat® CDx FLT3 Mutation Assay and related molecular diagnostics testing capabilities.

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