AML Archives - Invivoscribe

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, [...]

> Read More

Invivoscribe Submits LeukoStrat® CDx FLT3 Mutation Assay to NMPA in China and Expands Company, Adding Laboratory in Shanghai to Provide Comprehensive Support for Partners.

admin2020-05-12T17:03:17+00:00May 12th, 2020|Categories: Press Releases|Tags: ADMIRAL, AML, Astellas, Australia, CE-Marked, China, Clinical Trials, Companion Diagnostics, Europe, FLT3 biomarker, Germany, gilteritinib, Invivoscribe, Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd., ITD, Japan, LabPMM, LeukoStrat® CDx FLT3 Mutation Assay, NMPA, QuANTUM-R, RATIFY, refractory FLT3-mutated AML, relapsed FLT3-mutated AML., Rydapt®, Shanghai, Switzerland, TKD, United States, VANFLYTA®, Xospata®|

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

> Read More

The European Commission Approves Astellas’ XOSPATA® for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation Detected by Validated Tests, including the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay

admin2019-12-19T21:12:13+00:00December 5th, 2019|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, Astellas, EDTA, FLT3, Japan, LeukoStrat, LeukoStrat® CDx FLT3 Mutation Assay, Xospata®|

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

> Read More

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|

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

> Read More

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, [...]

> Read More

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®|

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

> Read More

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|

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

> Read More

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|

DOWNLOAD POSTER ⟶

> Read More

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 ⟶

> Read More

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|

⟵ PRESS RELEASES PRESS RELEASE SILVER SPRING, [...]

> Read More

Load More Posts

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 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.

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

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

October 1st, 2019
Stability and uniqueness of clonal immunoglobulin CDR3 sequences for MRD tracking in multiple myeloma

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

Invivoscribe Submits LeukoStrat® CDx FLT3 Mutation Assay to NMPA in China and Expands Company, Adding Laboratory in Shanghai to Provide Comprehensive Support for Partners.

The European Commission Approves Astellas’ XOSPATA® for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation Detected by Validated Tests, including the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay

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

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

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 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

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

October 1st, 2019 Stability and uniqueness of clonal immunoglobulin CDR3 sequences for MRD tracking in multiple myeloma

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

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

October 1st, 2019
Stability and uniqueness of clonal immunoglobulin CDR3 sequences for MRD tracking in multiple myeloma