Japan Archives - Invivoscribe

PRODUCTS
- Products Overview
  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.
  EXPLORE PRODUCTS ⟶
- Next-Generation Sequencing
  CE-IVD
  Illumina®
  Thermo Fisher®
  RUO
  Illumina®
  Thermo Fisher®
- ABI Fluorescence Detection
  CE-IVD
  Clonality
  FLT3
  RUO
  Clonality
  FLT3
  Translocations
  Companion Diagnostics
- Gel Detection
  CE-IVD
  Clonality
  FLT3
  Translocations
  RUO
  Clonality
  FLT3
  Translocations
- Controls
  Master Mix Controls
  DNA Controls
  RNA Controls
  MRD Controls
- Reagents
  ASRs
  Enzymes
  Hi-Di Formamide
- Companion Diagnostics (CDx)
- 2019 Product Catalog
CLINICAL LAB SERVICES
- Clinical Lab Services Overview
  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.
  EXPLORE SERVICES ⟶
- NGS Cancer Panels
  MyMRD
  MyAML
  MyHEME
- MRD NGS Tests
  Clonality
  FLT3 ITD
  NPM1
- Targeted Genes
  FLT3
  NPM1
- Clonality NGS Tests
  SHM
  IGH
  IGK
  TRG
  TRB
- Companion Diagnostic (CDx) Tests
  CDx – USA
  CDx – Germany
  CDx – Japan
- Custom Assays
- 2019 Services Catalog
DISEASES
- Lymphoid
  Mature B-cell
  Mature T-cell
- Myeloid
  Myelodysplastic Syndromes (MDS)
  Acute Myeloid Leukemia (AML)
  Myeloproliferative Neoplasms (MPNs)
- Hematological Testing Menu
  Browse our comprehensive menu of product & testing services.
  EXPLORE MENU ⟶
PARTNERSHIPS
- Partnerships Overview
  A proven strategy to accelerate
  drug approvals
  EXPLORE PARTNERSHIPS ⟶
- Product Development
  Design Controls, Bioinformatics Software, Identify & Track, Custom Development, and Complementary MRD Assays
  EXPLORE ⟶
- Manufacturing
  cGMP Compliant, CE-marked IVDs & CDx Manufacturing, Assay Development, and Controls & Reagents
  EXPLORE ⟶
- LabPMM®
  Clinical Lab Experience, Internationally Standardized, Comprehensive Panels, Complementary MRD Assays, and Worldwide Enrollment
  EXPLORE ⟶
- Global Regulatory Expertise
  Accredited & Proven, Registered Medical Device Establishment, Multiple CDx Approvals, CE-marked IVDs, and Marketing Authorization Holder (MAH)
  EXPLORE ⟶
SCIENCE
- Science Overview
  We take pride in expanding the science that bridges personalized medicine with quality healthcare.
  EXPLORE OUR SCIENCE ⟶
- Personalized Medicine
  Personalized Molecular Medicine^® is use of genomics and patient specific information to identify optimal treatment for each patient.
  EXPLORE PERSONALIZED MEDICINE ⟶
PUBLICATIONS
- Featured Publication
  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
  VIEW PUBLICATION ⟶
- Latest Publications
  August 25th, 2018
  A next-generation sequencing–based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations
  VIEW PUBLICATION ⟶
  August 22nd, 2018
  Simple deep sequencing-based post-remission MRD surveillance predicts clinical relapse in B-ALL
  VIEW PUBLICATION ⟶
  VIEW ALL PUBLICATIONS ⟶
COMPANY
- Company
  About Us
  Leadership Team
  Newsroom
  Global Distributors
  Licensure and Certifications
  Search Career Openings
- Invivoscribe Locations
  
  Invivoscribe, Inc. (USA)
  San Diego, CA, US
  CONTACT US ⟶
  
  Invivoscribe, SARL (France)
  La Ciotat, France
  CONTACT US ⟶
  
  Invivoscribe Diagnostic Technologies,(Shanghai) Co.,Ltd.
  Shanghai, China
  CONTACT US ⟶
- LabPMM Locations
  
  LabPMM, LLC (USA)
  San Diego, CA, US
  CONTACT US ⟶
  
  LabPMM, GmbH (Germany)
  Martinsried, Germany
  CONTACT US ⟶
  
  LabPMM, GK (Japan)
  Kanagawa 210-0821, Japan
  CONTACT US ⟶
- Support
  
  Invivoscribe, Inc. (USA)
  CONTACT US ⟶
  
  Invivoscribe, SARL (France)
  CONTACT US ⟶
  
  Invivoscribe Diagnostic Technologies,(Shanghai) Co.,Ltd.
  CONTACT US ⟶
  
  LabPMM, LLC (USA)
  CONTACT US ⟶
  
  LabPMM, GmbH (Germany)
  CONTACT US ⟶
  
  LabPMM, GK (Japan)
  CONTACT US ⟶
SEARCH
- Search by Keyword
  Search for:

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, [...]

Invivoscribe Expanding Clinical Laboratory Network Space and Testing Capabilities in San Diego, Germany, Japan, and China. Offering Comprehensive Standardized Testing for All Hematologic Malignancies

admin2019-07-04T21:09:04+00:00May 21st, 2019|Categories: Press Releases|Tags: China, Germany, Hematologic Malignancies, Japan, LabPMM, US|

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

Invivoscribe Submits LeukoStrat CDx FLT3 Mutation Assay both in the US and Japan to Support Daiichi Sankyo Submissions for Quizartinib

admin2019-07-04T21:07:22+00:00November 19th, 2018|Categories: Press Releases|Tags: Japan, LeukoStrat, LeukoStrat® CDx FLT3 Mutation Assay, Quizartinib, US|

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

Invivoscribe Submits the LeukoStrat CDx FLT3 Mutation Assay to Support Daiichi Sankyo Submission for Quizartinib in Japan

admin2019-07-04T21:07:12+00:00November 19th, 2018|Categories: Press Releases|Tags: Japan, LeukoStrat, LeukoStrat® CDx FLT3 Mutation Assay, Quizartinib, US|

⟵ 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)

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®|

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

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, [...]

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

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 Expanding Clinical Laboratory Network Space and Testing Capabilities in San Diego, Germany, Japan, and China. Offering Comprehensive Standardized Testing for All Hematologic Malignancies

Invivoscribe Submits LeukoStrat CDx FLT3 Mutation Assay both in the US and Japan to Support Daiichi Sankyo Submissions for Quizartinib

Invivoscribe Submits the LeukoStrat CDx FLT3 Mutation Assay to Support Daiichi Sankyo Submission for Quizartinib 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® 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

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