AML Archives - Invivoscribe

Japan’s MHLW Approves Invivoscribe’s LeukoStrat CDx FLT3 Mutation Assay as the CDx for Daiichi Sankyo’s Quizartinib for Treatment of Relapsed/Refractory FLT3-ITD AML. Expands Use to Include Specimens Collected in EDTA

admin2019-07-04T21:08:52+00:00June 19th, 2019|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, EDTA, FLT3-ITD AML, Japan, LeukoStrat, LeukoStrat® CDx FLT3 Mutation Assay, MHLW|

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Invivoscribe® Receives Approval In Japan For Its Leukostrat® Cdx Flt3 Mutation Assay To Assess Acute Myeloid Leukemia (AML) Patients Eligible For Treatment With Xospata® (Gilteritinib Fumarate)

wmm2019-07-04T21:06:44+00:00September 27th, 2018|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, Gilteritinib Fumarate, Japan, LeukoStrat, LeukoStrat® CDx FLT3 Mutation Assay, Quizartinib, Xospata®|

⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...]

Invivoscribe® Receives Approval in Japan for its LeukoStrat® CDx FLT3 Mutation Assay to Assess Acute Myeloid Leukemia (AML) Patients Eligible for Treatment with Xospata® (gilteritinib fumarate)

admin2019-07-04T21:06:52+00:00September 27th, 2018|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, Gilteritinib Fumarate, Japan, LeukoStrat, LeukoStrat® CDx FLT3 Mutation Assay, Quizartinib, Xospata®|

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Invivoscribe Submits Pre-Market Approval Application in Japan and Panel Track Supplement in the US to Screen Acute Myeloid Leukemia (AML) Patients for FLT3 Mutations

admin2019-07-04T21:11:12+00:00May 8th, 2018|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, FLT3, FLT3 Mutations, Japan, Pre-Market Approval, US|

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Genetic Heterogeneity and Stratification of AML Samples with NPM1 Mutation Detected by the MyAML® NGS Test

admin2019-05-19T19:21:56+00:00November 16th, 2017|Categories: Posters|Tags: AML, Genetic Heterogeneity, MyAML, NGS Test, NPM1, Stratification|

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Validation of the LeukoStrat® CDx FLT3 Mutation Assay: Used to Detect both Internal Tandem Duplication (ITD) and Tyrosine Kinase Domain (TKD) Mutations and Response to Midostaurin in 1058 Patients with AML

admin2019-05-28T17:39:17+00:00November 16th, 2017|Categories: Posters|Tags: AML, Internal Tandem Duplication, ITD, LeukoStrat, LeukoStrat® CDx FLT3 Mutation Assay, Midostaurin, TKD, Tyrosine Kinase Domain|

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FDA approves new combination treatment for acute myeloid leukemia

wmm2019-07-04T21:14:53+00:00April 28th, 2017|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, Combination Treatment, FDA, FDA Approval|

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Invivoscribe® Receives FDA Approval for the LeukoStrat® CDx FLT3 Mutation Assay Companion Diagnostic Test for the Selection of Patients for Rydapt® and is the First Companion Diagnostic for AML

wmm2019-07-04T21:16:10+00:00April 28th, 2017|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, CDx, Companion Diagnostics, FDA, FDA Approval, LeukoStrat, LeukoStrat® CDx FLT3 Mutation Assay, Rydapt®|

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AMP 2016 MRD Solutions for the Studies of Hematologic Malignancies – FLT3 ITD MRD

admin2019-05-28T17:45:42+00:00November 19th, 2016|Categories: Featured Videos, Videos|Tags: Acute Myeloid Leukemia, AML, AMP, AMP 2016, Clinical Laboratories, Dr. Brad Patay, FLT3, FLT3 ITD MRD, Hematologic Malignancies, ITD, LabPMM, Minimal Residual Disease, MRD, Next-Generation Sequencing, NGS|

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Novartis drug PKC412 (midostaurin) granted FDA Priority Review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis

wmm2019-07-04T21:27:37+00:00November 14th, 2016|Categories: Press Releases|Tags: Acute Myeloid Leukemia, Advanced Systemic Mastocytosis, AML, FDA, FDA Priority Review, FLT3, FLT3-mutated AML, Midostaurin, Novartis, Novartis drug PKC412|

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Invivoscribe provides a full range of standardized CE-marked in vitro diagnostic cGMP products for hematology-oncology, as well as RUO assays, analyte specific reagents (ASRs), and DNA & RNA controls.

The Laboratory for Personalized Molecular Medicine^® (LabPMM^®) at Invivoscribe offer internationally standardized testing of novel and proprietary biomarkers that are critically important for patient care.

Browse our comprehensive menu of product & testing services.

A proven strategy to accelerate
drug approvals

Design Controls, Bioinformatics Software, Identify & Track, Custom Development, and Complementary MRD Assays

cGMP Compliant, CE-marked IVDs & CDx Manufacturing, Assay Development, and Controls & Reagents

Clinical Lab Experience, Internationally Standardized, Comprehensive Panels, Complementary MRD Assays, and Worldwide Enrollment

Accredited & Proven, Registered Medical Device Establishment, Multiple CDx Approvals, CE-marked IVDs, and Marketing Authorization Holder (MAH)

We take pride in expanding the science that bridges personalized medicine with quality healthcare.

Personalized Molecular Medicine^® is use of genomics and patient specific information to identify optimal treatment for each patient.

March 21st, 2019
Establishment of Immunoglobulin Heavy (IGH) Chain Clonality Testing by Next-Generation Sequencing for Routine Characterization of B-Cell and Plasma Cell Neoplasms

August 25th, 2018
A next-generation sequencing–based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations

August 22nd, 2018
Simple deep sequencing-based post-remission MRD surveillance predicts clinical relapse in B-ALL

Japan’s MHLW Approves Invivoscribe’s LeukoStrat CDx FLT3 Mutation Assay as the CDx for Daiichi Sankyo’s Quizartinib for Treatment of Relapsed/Refractory FLT3-ITD AML. Expands Use to Include Specimens Collected in EDTA

Invivoscribe® Receives Approval In Japan For Its Leukostrat® Cdx Flt3 Mutation Assay To Assess Acute Myeloid Leukemia (AML) Patients Eligible For Treatment With Xospata® (Gilteritinib Fumarate)

Invivoscribe® Receives Approval in Japan for its LeukoStrat® CDx FLT3 Mutation Assay to Assess Acute Myeloid Leukemia (AML) Patients Eligible for Treatment with Xospata® (gilteritinib fumarate)

Invivoscribe Submits Pre-Market Approval Application in Japan and Panel Track Supplement in the US to Screen Acute Myeloid Leukemia (AML) Patients for FLT3 Mutations

Genetic Heterogeneity and Stratification of AML Samples with NPM1 Mutation Detected by the MyAML® NGS Test

Validation of the LeukoStrat® CDx FLT3 Mutation Assay: Used to Detect both Internal Tandem Duplication (ITD) and Tyrosine Kinase Domain (TKD) Mutations and Response to Midostaurin in 1058 Patients with AML

FDA approves new combination treatment for acute myeloid leukemia

Invivoscribe® Receives FDA Approval for the LeukoStrat® CDx FLT3 Mutation Assay Companion Diagnostic Test for the Selection of Patients for Rydapt® and is the First Companion Diagnostic for AML

AMP 2016 MRD Solutions for the Studies of Hematologic Malignancies – FLT3 ITD MRD

Novartis drug PKC412 (midostaurin) granted FDA Priority Review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis

Invivoscribe provides a full range of standardized CE-marked in vitro diagnostic cGMP products for hematology-oncology, as well as RUO assays, analyte specific reagents (ASRs), and DNA & RNA controls.

The Laboratory for Personalized Molecular Medicine® (LabPMM®) at Invivoscribe offer internationally standardized testing of novel and proprietary biomarkers that are critically important for patient care.

Browse our comprehensive menu of product & testing services.

A proven strategy to acceleratedrug approvals

Design Controls, Bioinformatics Software, Identify & Track, Custom Development, and Complementary MRD Assays

cGMP Compliant, CE-marked IVDs & CDx Manufacturing, Assay Development, and Controls & Reagents

Clinical Lab Experience, Internationally Standardized, Comprehensive Panels, Complementary MRD Assays, and Worldwide Enrollment

Accredited & Proven, Registered Medical Device Establishment, Multiple CDx Approvals, CE-marked IVDs, and Marketing Authorization Holder (MAH)

We take pride in expanding the science that bridges personalized medicine with quality healthcare.

Personalized Molecular Medicine® is use of genomics and patient specific information to identify optimal treatment for each patient.

March 21st, 2019 Establishment of Immunoglobulin Heavy (IGH) Chain Clonality Testing by Next-Generation Sequencing for Routine Characterization of B-Cell and Plasma Cell Neoplasms

August 25th, 2018 A next-generation sequencing–based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations

August 22nd, 2018 Simple deep sequencing-based post-remission MRD surveillance predicts clinical relapse in B-ALL

The Laboratory for Personalized Molecular Medicine^® (LabPMM^®) at Invivoscribe offer internationally standardized testing of novel and proprietary biomarkers that are critically important for patient care.

A proven strategy to accelerate
drug approvals

Personalized Molecular Medicine^® is use of genomics and patient specific information to identify optimal treatment for each patient.

March 21st, 2019
Establishment of Immunoglobulin Heavy (IGH) Chain Clonality Testing by Next-Generation Sequencing for Routine Characterization of B-Cell and Plasma Cell Neoplasms

August 25th, 2018
A next-generation sequencing–based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations

August 22nd, 2018
Simple deep sequencing-based post-remission MRD surveillance predicts clinical relapse in B-ALL