Midostaurin Archives - Invivoscribe

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  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
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  A next-generation sequencing–based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations
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  August 22nd, 2018
  Simple deep sequencing-based post-remission MRD surveillance predicts clinical relapse in B-ALL
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Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States

admin2020-05-19T16:22:45+00:00May 19th, 2020|Categories: Press Releases|Tags: 3500xL Dx Genetic Analyzer, Acute Myelogenous Leukemia, Acute Myeloid Leukemia, AML, Analysis Software, Commercial Companion Diagnostics, Companion Diagnostics, D835, FDA Approval, FLT3 mut + AML Patients, FLT3 Mutation Test, Gilteritinib Fumarate, I836, In vitro Diagnostic Test, Internal Tandem Duplication, Invivoscribe, ITD, IVD Kit, LabPMM, LeukoStrat® CDx FLT3 Mutation Assay, Midostaurin, PCR-Based, Precision Diagnostics, Quizartinib, Quizartinib Hydrochloride, Relapsed/Refractory, Rydapt®, TKD, Tyrosine Kinase Domain, United States, US, Xospata®|

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

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|

DOWNLOAD POSTER ⟶

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|

⟵ PRESS RELEASES PRESS RELEASE Basel - [...]

Novartis drug PKC412 (midostaurin) receives Breakthrough Therapy designation from the FDA for newly-diagnosed FLT3-mutated acute myeloid leukemia (AML)

wmm2019-07-04T21:30:56+00:00February 18th, 2016|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, FDA, FLT3, FLT3-mutated AML, Midostaurin, Novartis, Novartis drug PKC412|

⟵ PRESS RELEASES PRESS RELEASE Basel - [...]

Novartis drug PKC412 (midostaurin) improves overall survival by 23% in global Phase III study of AML patients with FLT3 mutations

wmm2019-07-04T21:32:51+00:00December 5th, 2015|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, FLT3, FLT3 Mutations, Midostaurin, Novartis, Novartis drug PKC412, Phase III|

⟵ PRESS RELEASES PRESS RELEASE EAST HANOVER, [...]

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.

CORONAVIRUS COVID-19 TESTING Performed with real-time reverse transcription polymerase chain reaction (RT-PCR) to detect nucleic acid from SARS-CoV-2.

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

Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States

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

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

Novartis drug PKC412 (midostaurin) receives Breakthrough Therapy designation from the FDA for newly-diagnosed FLT3-mutated acute myeloid leukemia (AML)

Novartis drug PKC412 (midostaurin) improves overall survival by 23% in global Phase III study of AML patients with FLT3 mutations

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.

CORONAVIRUS
COVID-19 TESTING

Performed with real-time reverse transcription polymerase chain reaction (RT-PCR) to detect nucleic acid from SARS-CoV-2.

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