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TEST:
LeukoStrat® CDx FLT3 Mutation Assay

Type:
FDA Approved
Related tests:
15d
LLS 2024 ELN-REFINED RISK STRATIFICATION IN OLDER ADULTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA TREATED WITH LOW-INTENSITY THERAPY (EHA 2024)
Among patients ≥60 yrs with ND AML given LIT, the current 2022 ELN risk system classifies most (79%)patients as adverse risk and does not reliably distinguish favorable from intermediate-risk, highlighting thelimitations of the model in this patient population. We propose a refined LLS classification using a "mutationscore" incorporating IDH2, MLL2, KRAS and TP53 mutations for those previously assigned ELN 2022 adverserisk, as well as redefining the definition of LLS-favorable risk.
Clinical
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KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • KMT2D (Lysine Methyltransferase 2D) • MLL2 (Myeloid/lymphoid or mixed-lineage leukemia 2)
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TP53 mutation • KRAS mutation • FLT3-ITD mutation • IDH2 mutation • FLT3 mutation • KMT2D mutation • TP53 mutation + KRAS mutation • MLL2 mutation • KRAS mutation + TP53 mutation
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FoundationOne® Heme CDx • LeukoStrat® CDx FLT3 Mutation Assay
7ms
Quantum-First (Q-F): Clinical Bridging Study for FMS-like Tyrosine Kinase 3–Internal Tandem Duplication (FLT3-ITD) Companion Diagnostic Development (ASH 2023)
Background Q-F (NCT02668653) showed that the highly potent, selective, type 2 FLT3 inhibitor quizartinib (Q) + standard chemotherapy ± transplantation, followed by Q monotherapy for ≥36 cycles, reduced the relative risk of death by 22.4% vs placebo (P) in newly diagnosed (nd) FLT3-ITD+ AML, with HR of 0.776 and P value of 0.0324 (PMID: 37116523)...Conclusions This study showed 1) agreement between CDx & CTA in identifying nd FLT3-ITD+ AML pts and 2) that OS benefit provided by Q in the ITT CDx+ population is comparable with the OS benefit in the ITT population of Q-F. The LeukoStrat CDx FLT3 Mutation Assay aids in assessing AML pts for Q therapy.
Clinical • Companion diagnostic
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FLT3 (Fms-related tyrosine kinase 3)
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FLT3-ITD mutation • FLT3 mutation
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LeukoStrat® CDx FLT3 Mutation Assay
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Vanflyta (quizartinib)
7ms
Genomic Characterization of Newly Diagnosed Acute Myeloid Leukemia in Patients Age 60 Years and Older; A Report from the Beat AML Master Trial (ASH 2023)
Blue indicates positive correlation, red indicated negative correlation. Only significant correlations (p<0.01) are shown.
Clinical
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TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • NRAS (Neuroblastoma RAS viral oncogene homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • DNMT3A (DNA methyltransferase 1) • RUNX1 (RUNX Family Transcription Factor 1) • SF3B1 (Splicing Factor 3b Subunit 1) • ASXL1 (ASXL Transcriptional Regulator 1) • TET2 (Tet Methylcytosine Dioxygenase 2) • PTPN11 (Protein Tyrosine Phosphatase Non-Receptor Type 11) • SRSF2 (Serine and arginine rich splicing factor 2) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • STAG2 (Stromal Antigen 2)
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TP53 mutation • FLT3-ITD mutation • IDH1 mutation • IDH2 mutation • FLT3 mutation • NPM1 mutation • DNMT3A mutation • ASXL1 mutation • TET2 mutation • SF3B1 mutation • SRSF2 mutation • U2AF1 mutation • STAG2 mutation
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FoundationOne® Heme CDx • LeukoStrat® CDx FLT3 Mutation Assay
7ms
Optimization of FLT3 Detection of Internal Tandem Duplication (ITD) at Moffitt Cancer Center (AMP 2023)
FLT3 ITDs are associated with higher risk and unfavorable outcomes; however, targeted therapy with midostaurin and gilteritinib has been FDA approved, and detection during diagnosis is critical for initiating timely treatment. Modifications of the final volume of PCR mixes, DNA input, and capillary length do not significantly affect the assay's performance. The described modifications reduce reagents, DNA consumption, and the cost of the assay.
FLT3 (Fms-related tyrosine kinase 3)
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FLT3 mutation
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LeukoStrat® CDx FLT3 Mutation Assay
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Xospata (gilteritinib) • Rydapt (midostaurin)
10ms
FDA approves quizartinib for newly diagnosed acute myeloid leukemia (FDA)
"On July 20, 2023, the Food and Drug Administration approved quizartinib (Vanflyta, Daiichi Sankyo, Inc.) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test...FDA also approved LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Vanflyta."
Regulatory
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LeukoStrat® CDx FLT3 Mutation Assay
1year
NPM1 MUTATED ACUTE MYELOID LEUKEMIA: THE CO-MUTATION PATTERNS MAY BE ASSOCIATED WITH PROGNOSIS (EHA 2023)
Nineteen patients received intensive chemotherapy and two hypomethylating agents +/- venetoclax (cycles 8-9)... Using NGS techniques in AML NPM1+ patients detects concurrent mutations with potential prognostic significance and can contribute to daily clinical practice. These techniques must be carried out in patients diagnosed with AML who will receive treatment and only in specialized and accredited centers. Molecular markers, Acute myeloid leukemia, Prognostic groups
FLT3 (Fms-related tyrosine kinase 3) • NRAS (Neuroblastoma RAS viral oncogene homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • DNMT3A (DNA methyltransferase 1)
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NRAS mutation • FLT3-ITD mutation • NPM1 mutation • DNMT3A mutation
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LeukoStrat® CDx FLT3 Mutation Assay
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Venclexta (venetoclax)
1year
Invivoscribe announces IVDR approval of the LeukoStrat® CDx FLT3 Mutation Assay (Invivoscribe Press Release)
"'Today we are pleased to announce that Invivoscribe’s LeukoStrat® CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA as a Class C CDx assay, meeting the stringent new IVDR (Regulation (EU) 2017/746) requirements. Invivoscribe is one of the first companies in the world to gain an IVDR approval of a CDx assay. IVDR is a set of regulations that came into effect on May 26, 2022 that were put in place by the Europe Union (EU) to ensure the safety, traceability, quality and performance of in-vitro diagnostic medical devices (IVDs),' says Jason Gerhold, Global Director of Regulatory, Quality, and Clinical Affairs at Invivoscribe."
European regulatory
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LeukoStrat® CDx FLT3 Mutation Assay
over1year
Patient Specific Droplet Digital PCR Targeting FLT3-ITD Allows to Detect Small Clones in Acute Leukemias at Diagnosis and during Follow-up (ASH 2022)
Finally, our study demonstrates that in patients FLT3-ITD positive at diagnosis, ddPCR allows to detect the persistence or the reappearance of small clones that expand until clinical relapse. The possibility of an early diagnosis of molecular relapse offers a window of time for intervention with selective FLT3 inhibitors in the attempt to prevent or delay relapse.
Clinical
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FLT3 (Fms-related tyrosine kinase 3)
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FLT3-ITD mutation • FLT3 mutation • FLT3 wild-type
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LeukoStrat® CDx FLT3 Mutation Assay
over1year
Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with Newly Diagnosed FLT3-ITD Positive AML (Canada Newswire)
"Invivoscribe is pleased to announce that they have filed a supplemental Pre-Market Approval (sPMA) submission with the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) for the use of the LeukoStrat® CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo's investigational drug quizartinib. The assay is used for the identification of newly diagnosed acute myeloid leukemia (AML) patients that have the FLT3-ITD mutation....The filing supports Daiichi Sankyo's new drug application (NDA) for quizartinib for the proposed treatment of adult patients with newly diagnosed FLT3-ITD positive AML, which was granted Priority Review by the FDA."
FDA event
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LeukoStrat® CDx FLT3 Mutation Assay
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Vanflyta (quizartinib)
over2years
FDA Cleared Companion Diagnostics (CDx) Tests (IDH1, IDH2 and FLT3) for Acute Myeloid Leukemia (AML) Patient Care (ASH 2021)
In recent years the US Food and Drug Administration (FDA) has been very active in approving targeted therapeutic drugs for AML patients including Midostaurin (Rydapt; 2017) and Gilteritinib (Xospata;2018) for FLT3 mutations; Enasidenib (Idhifa; 2017) for IDH2 mutations and Ivosidenib (Tibsovo; 2018) for IDH1 mutations. The IDH1 CDx, IDH2 CDx and FLT3 CDx tests are highly sensitive and Versiti provides average turn around time of 3 business days which enable rapid decision making on the recently available drug therapies for AML patients. We strongly recommend that the IDH1 CDx, IDH2 CDx and FLT3 CDx tests should be performed on all AML patients for better care.
Clinical • Companion diagnostic
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FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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IDH1 mutation • IDH2 mutation • FLT3 mutation • IDH1 R132H • FLT3 D835 • IDH2 R172K • IDH1 R132C • IDH1 R132 • FLT3 I836 • IDH1 R132G • IDH2 R140Q • IDH2 R140 • IDH2 R172 • IDH2 R172G
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LeukoStrat® CDx FLT3 Mutation Assay
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Xospata (gilteritinib) • Rydapt (midostaurin) • Tibsovo (ivosidenib) • Idhifa (enasidenib)
over3years
Clinical
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FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • DNMT3A (DNA methyltransferase 1)
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FLT3-ITD mutation • FLT3 mutation • NPM1 mutation • DNMT3A mutation
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LeukoStrat® CDx FLT3 Mutation Assay
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Xospata (gilteritinib)
over3years
[VIRTUAL] FLT3 Internal Tandem Duplication Quantitation and Length Analysis By Digital PCR Paired with High-Speed AFM (ASH 2020)
(D) Spiked-in VAF v. detected VAF is shown for FLT3-ITD samples with 30 bp and 126 bp insertions, with spiked-in VAF ranging from 5%–100%. Vertical bars give the VAFs for ROPEs ± 10% of the initial ROPE width, which conveys the sensitivity of each VAF to the ROPE width.
FLT3 (Fms-related tyrosine kinase 3)
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FLT3 mutation
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LeukoStrat® CDx FLT3 Mutation Assay