Midostaurin Archives - Invivoscribe

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  Comparison of next-generation sequencing (NGS) and next-generation flow (NGF) for minimal residual disease (MRD) assessment in multiple myeloma
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  Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia
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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, [...]

US FDA approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas drug XOSPATA (gilteritinib fumarate) for treatment of AML patients in the US

Invivoscribe also Receives National Reimbursement for CDx Assay in Japan

admin2020-05-29T00:00:58+00:00November 29th, 2018|Categories: Press Releases|Tags: Acute Myelogenous Leukemia, Acute Myeloid Leukemia, AML, Analysis Software, Commercial Companion Diagnostics, Companion Diagnostics, 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.

August 13th, 2020 Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia

October 30th, 2020 Comparison of next-generation sequencing (NGS) and next-generation flow (NGF) for minimal residual disease (MRD) assessment in multiple myeloma

August 13th, 2020 Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia

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

US FDA approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas drug XOSPATA (gilteritinib fumarate) for treatment of AML patients in the USInvivoscribe also Receives National Reimbursement for CDx Assay in Japan

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.

August 13th, 2020
Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia

October 30th, 2020
Comparison of next-generation sequencing (NGS) and next-generation flow (NGF) for minimal residual disease (MRD) assessment in multiple myeloma

August 13th, 2020
Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia

US FDA approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas drug XOSPATA (gilteritinib fumarate) for treatment of AML patients in the US

Invivoscribe also Receives National Reimbursement for CDx Assay in Japan