Companion Diagnostics (CDx)2024-10-28T15:02:19-07:00
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.

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

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

As the CDx to midostaurin (US), gilteritinib fumarate (US, Japan, EU, Switzerland) and quizartinib hydrochloride (US, Japan, EU), 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 CDx 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.

K4120431 CE-2797 IVD (EU) ⟶
K4120361 IVD (US) ⟶
K4120331 IVD (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 Leukemia in adults, and 1 out of 3 diagnosed with AML are expected to have presence of FLT3 activating mutations.  The presence of FLT3 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 mutation.1,2  Therefore, 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 testing is recommended for newly diagnosed AML patients, and FLT3 mutation status may change with relapse/refractory AML.  Additionally, FLT3 targeted therapies are approved for newly diagnosed and/or relapse/refractory AML across various global regions warranting the application of FLT3 testing across the course of AML disease.

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 tools enabling the identification of biomarkers that indicate the patients most likely to benefit (or alternately not benefit) from specific or combinatorial targeted therapies.  For cancer patients, a CDx might detect a biomarker that is predictive of a treatment regimen’s effect on an individualized patient cancer based on the underlying genetics or biology of that patient.  Screening patients for known biomarkers assists in ascertaining optimal, individualized treatment options for patients.  In doing so, patients known not to benefit from a drug (due to the absent biomarker) are further spared unnecessary treatments and the possible negative side effects.

THE SOLUTION FOR FLT3 TESTING

The LeukoStrat CDx FLT3 Mutation Assay is a complete solution for FLT3 ITD and FLT3 TKD detection with software automated mutant identification, mutant to wild type signal ratio reports, and clinical interpretation.

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic (IVD) targeting regions of the FLT3 gene to identify ITD and TKD (D835, I836) activation mutations in patient samples.  Automated software identifies mutations, generates mutant to wild type signal ratios, and 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 Assay, which served as the companion diagnostic in the collective ADMIRAL, RATIFY and QuANTUM-R clinical trials, each respectively used in approvals of Xospata®, Rydapt® and Vanflyta®.

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.  In recent years, management of AML disease improved with the development of tyrosine kinase inhibitors (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 Internal Tandem Duplication (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. Clinical studies have found FLT3 ITD mutations are associated with higher numbers of leukemic cells, increased incidence of relapse, and decreased overall survival.  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 that is 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. Murphy, KM. et al., (2003). Detection of FLT3 Internal Tandem Duplication and D835 Mutations by a Multiplex Polymerase Chain Reaction and Capillary Electrophoresis Assay. The Journal of Molecular Diagnostics 5, 96 – 102.
2. Yamamoto, Y. et al., (2001). Activating mutation of D835 within the activation loop of FLT3 in human hematologic malignancies. Blood 97, 2434-2439.

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