Japan Archives - Invivoscribe

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®|

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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®|

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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 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|

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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|

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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|

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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®|

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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)

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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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.

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 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

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

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

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