Press Releases

LATEST PRESS

Invivoscribe Announces Registration of the LeukoStrat^® CDx FLT3 Mutation Assay in the United Kingdom and Switzerland

Invivoscribe Marketing2025-03-28T10:05:45-07:00March 27th, 2025|2025 Press Releases, Press Releases|

EU Notified Body (BSI Netherlands) and the EMA Grant Approval of the LeukoStrat® CDx FLT3 Mutation Assay for VANFLYTA® Therapy in the EU and EEA

wmm2024-10-08T03:14:44-07:00October 8th, 2024|2024 Press Releases, Press Releases|

Study Suggests Critical Link Between Residual FLT3-ITD Mutations in Remission and Post-Transplant Outcomes in AML

Invivoscribe Marketing2024-05-07T17:44:56-07:00May 8th, 2024|2024 Press Releases, Press Releases|

Invivoscribe Announces FDA Approval of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with FLT3-ITD Positive AML for Treatment with VANFLYTA

Invivoscribe Marketing2023-07-20T17:27:41-07:00July 21st, 2023|2023 Press Releases, Press Releases|

Invivoscribe Partners with Complete Genomics to Develop and Commercialize Biomarker Tests for Oncology and Cancer Research

Invivoscribe Marketing2023-06-05T12:37:16-07:00June 2nd, 2023|2023 Press Releases, Press Releases|

Invivoscribe Announces Updated Reimbursement for the LeukoStrat CDx FLT3 Mutation Assay to Select Newly Diagnosed FLT3-ITD Positive AML Patients Eligible for VANFLYTA in Japan

Invivoscribe Marketing2023-05-25T17:09:22-07:00May 25th, 2023|2023 Press Releases, Press Releases|

Invivoscribe Announces Registration of the LeukoStrat^® CDx FLT3 Mutation Assay in the United Kingdom and Switzerland

March 27th, 2025|2025 Press Releases, Press Releases|

EU Notified Body (BSI Netherlands) and the EMA Grant Approval of the LeukoStrat® CDx FLT3 Mutation Assay for VANFLYTA® Therapy in the EU and EEA

October 8th, 2024|2024 Press Releases, Press Releases|

Study Suggests Critical Link Between Residual FLT3-ITD Mutations in Remission and Post-Transplant Outcomes in AML

May 8th, 2024|2024 Press Releases, Press Releases|

Invivoscribe Announces FDA Approval of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with FLT3-ITD Positive AML for Treatment with VANFLYTA

July 21st, 2023|2023 Press Releases, Press Releases|

Invivoscribe Partners with Complete Genomics to Develop and Commercialize Biomarker Tests for Oncology and Cancer Research

June 2nd, 2023|2023 Press Releases, Press Releases|

Invivoscribe Announces Updated Reimbursement for the LeukoStrat CDx FLT3 Mutation Assay to Select Newly Diagnosed FLT3-ITD Positive AML Patients Eligible for VANFLYTA in Japan

May 25th, 2023|2023 Press Releases, Press Releases|

Invivoscribe Announces IVDR Approval of the LeukoStrat CDx FLT3 Mutation Assay

May 11th, 2023|2023 Press Releases, Press Releases|

Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd. Receives CAP Accreditation to Support Clinical Research Testing for Pharmaceutical Partners in China

February 23rd, 2023|2023 Press Releases, Press Releases|

Invivoscribe Appoints Masato Sasaki as General Manager of LabPMM, GK (Japan)

February 1st, 2023|2023 Press Releases, Press Releases|

Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with Newly Diagnosed FLT3-ITD Positive AML

October 24th, 2022|2022 Press Releases, Press Releases|

Kronos Bio and Invivoscribe Partner on Companion Diagnostic for Use with Entospletinib, Kronos Bio’s Investigational Compound Being Developed for Patients with AML

August 16th, 2022|2022 Press Releases, Press Releases|

Hitachi High-Tech and Invivoscribe partner to advance molecular diagnostics and precision medicine

May 9th, 2022|2022 Press Releases, Press Releases|

Roswell Park Comprehensive Cancer Center Licenses Invivoscribe’s LymphoTrack Software for Plug and Play Pipeline Use

September 2nd, 2021|2021 Press Releases, Press Releases|

Invivoscribe Announces Key Submission in the EU, Expanded Presence and Activity in China

July 22nd, 2021|2021 Press Releases, Press Releases|

Invivoscribe Launches Grant Program to Support Novel Applications for Sequence-Based Analyses of the Immune System

June 24th, 2021|2021 Press Releases, Press Releases|

Invivoscribe Premieres 12-Color Flow Cytometry Capabilities at their Reference Labs in the US, Europe, and China

June 3rd, 2021|2021 Press Releases, Press Releases|

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

May 19th, 2020|2020 Press Releases, Press Releases|

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

May 12th, 2020|2020 Press Releases, Press Releases|

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

December 5th, 2019|2019 Press Releases, Press Releases|

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

June 19th, 2019|2019 Press Releases, Press Releases|

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

May 21st, 2019|2019 Press Releases, Press Releases|

Invivoscribe To Present At Biotech Showcase™ 2019 In San Francisco

January 3rd, 2019|2019 Press Releases, Press Releases|

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

November 29th, 2018|2018 Press Releases, Press Releases|

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

November 27th, 2018|2018 Press Releases, Press Releases|

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

November 19th, 2018|2018 Press Releases, Press Releases|

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)

September 27th, 2018|2018 Press Releases, Press Releases|

Invivoscribe Announces a Regional “Center of Excellence” Reference Laboratory in Beirut to Offer Specialized Gene Panels

May 9th, 2018|2018 Press Releases, Press Releases|

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

May 8th, 2018|2018 Press Releases, Press Releases|

Invivoscribe® Releases LymphoTrack® TRB Assay on MiSeq® and LymphoTrack® Minimal Residual Disease (MRD) Software

November 7th, 2017|2017 Press Releases, Press Releases|

Invivoscribe® Releases LeukoStrat® CDx FLT3 Mutation Assay as CE-marked IVD Assay Kit.

August 1st, 2017|2017 Press Releases, Press Releases|

FDA approves new combination treatment for acute myeloid leukemia

April 28th, 2017|2017 Press Releases, Press Releases|

Invivoscribe® Receives FDA Approval for the LeukoStrat® CDx FLT3 Mutation Assay Companion Diagnostic Test for the Selection of Patients for Rydapt® and is the First Companion Diagnostic for AML

April 28th, 2017|2017 Press Releases, Press Releases|

Invivoscribe Expands Business into Solid Tumors with Assays and Services to Identify and Monitor CAR-T and TCR Immuno-Therapies

March 28th, 2017|2017 Press Releases, Press Releases|

Invivoscribe Expands Ion PGM NGS Platform Menu: Releases Additional CE-IVD Clonality Kits with Bioinformatics Software and RUO Kits with MRD Software

February 28th, 2017|2017 Press Releases, Press Releases|

Invivoscribe Announces Long-Term Collaboration Agreement with Illumina and Plans Release of NGS-based IVD Assay Kits

February 14th, 2017|2017 Press Releases, Press Releases|

Invivoscribe Expands Long-Term Collaboration Agreement to Release FLT3 Mutation and Clonality Assay Kits

January 31st, 2017|2017 Press Releases, Press Releases|

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

November 14th, 2016|2016 Press Releases, Press Releases|

Ion Torrent Developers Alliance Program Designed to Speed Targeted NGS Assay Development

May 31st, 2016|2016 Press Releases, Press Releases|

German Supreme Court Upholds and Strengthens Invivoscribe FLT3 Patent Position

March 28th, 2016|2016 Press Releases, Press Releases|

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

February 18th, 2016|2016 Press Releases, Press Releases|

Invivoscribe Announces Long-Term Collaboration to Develop Immuno-Oncology Tests With Thermo Fisher Scientific

February 9th, 2016|2016 Press Releases, Press Releases|

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

December 5th, 2015|Archived Press Releases, Press Releases|

Invivoscribe Announces Registration of the LeukoStrat^® CDx FLT3 Mutation Assay in the United Kingdom and Switzerland

March 27th, 2025|2025 Press Releases, Press Releases|

EU Notified Body (BSI Netherlands) and the EMA Grant Approval of the LeukoStrat® CDx FLT3 Mutation Assay for VANFLYTA® Therapy in the EU and EEA

October 8th, 2024|2024 Press Releases, Press Releases|

Study Suggests Critical Link Between Residual FLT3-ITD Mutations in Remission and Post-Transplant Outcomes in AML

May 8th, 2024|2024 Press Releases, Press Releases|

Invivoscribe Announces FDA Approval of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with FLT3-ITD Positive AML for Treatment with VANFLYTA

July 21st, 2023|2023 Press Releases, Press Releases|

Invivoscribe Partners with Complete Genomics to Develop and Commercialize Biomarker Tests for Oncology and Cancer Research

June 2nd, 2023|2023 Press Releases, Press Releases|

Invivoscribe Announces Updated Reimbursement for the LeukoStrat CDx FLT3 Mutation Assay to Select Newly Diagnosed FLT3-ITD Positive AML Patients Eligible for VANFLYTA in Japan

May 25th, 2023|2023 Press Releases, Press Releases|

Invivoscribe Announces IVDR Approval of the LeukoStrat CDx FLT3 Mutation Assay

May 11th, 2023|2023 Press Releases, Press Releases|

Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd. Receives CAP Accreditation to Support Clinical Research Testing for Pharmaceutical Partners in China

February 23rd, 2023|2023 Press Releases, Press Releases|

Invivoscribe Appoints Masato Sasaki as General Manager of LabPMM, GK (Japan)

February 1st, 2023|2023 Press Releases, Press Releases|

Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with Newly Diagnosed FLT3-ITD Positive AML

October 24th, 2022|2022 Press Releases, Press Releases|

Kronos Bio and Invivoscribe Partner on Companion Diagnostic for Use with Entospletinib, Kronos Bio’s Investigational Compound Being Developed for Patients with AML

August 16th, 2022|2022 Press Releases, Press Releases|

Hitachi High-Tech and Invivoscribe partner to advance molecular diagnostics and precision medicine

May 9th, 2022|2022 Press Releases, Press Releases|

Roswell Park Comprehensive Cancer Center Licenses Invivoscribe’s LymphoTrack Software for Plug and Play Pipeline Use

September 2nd, 2021|2021 Press Releases, Press Releases|

Invivoscribe Announces Key Submission in the EU, Expanded Presence and Activity in China

July 22nd, 2021|2021 Press Releases, Press Releases|

Invivoscribe Launches Grant Program to Support Novel Applications for Sequence-Based Analyses of the Immune System

June 24th, 2021|2021 Press Releases, Press Releases|

Invivoscribe Premieres 12-Color Flow Cytometry Capabilities at their Reference Labs in the US, Europe, and China

June 3rd, 2021|2021 Press Releases, Press Releases|

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

May 19th, 2020|2020 Press Releases, Press Releases|

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

May 12th, 2020|2020 Press Releases, Press Releases|

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

December 5th, 2019|2019 Press Releases, Press Releases|

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

June 19th, 2019|2019 Press Releases, Press Releases|

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

May 21st, 2019|2019 Press Releases, Press Releases|

Invivoscribe To Present At Biotech Showcase™ 2019 In San Francisco

January 3rd, 2019|2019 Press Releases, Press Releases|

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

November 29th, 2018|2018 Press Releases, Press Releases|

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

November 27th, 2018|2018 Press Releases, Press Releases|

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

November 19th, 2018|2018 Press Releases, Press Releases|

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)

September 27th, 2018|2018 Press Releases, Press Releases|

Invivoscribe Announces a Regional “Center of Excellence” Reference Laboratory in Beirut to Offer Specialized Gene Panels

May 9th, 2018|2018 Press Releases, Press Releases|

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

May 8th, 2018|2018 Press Releases, Press Releases|

Invivoscribe® Releases LymphoTrack® TRB Assay on MiSeq® and LymphoTrack® Minimal Residual Disease (MRD) Software

November 7th, 2017|2017 Press Releases, Press Releases|

Invivoscribe® Releases LeukoStrat® CDx FLT3 Mutation Assay as CE-marked IVD Assay Kit.

August 1st, 2017|2017 Press Releases, Press Releases|

FDA approves new combination treatment for acute myeloid leukemia

April 28th, 2017|2017 Press Releases, Press Releases|

Invivoscribe® Receives FDA Approval for the LeukoStrat® CDx FLT3 Mutation Assay Companion Diagnostic Test for the Selection of Patients for Rydapt® and is the First Companion Diagnostic for AML

April 28th, 2017|2017 Press Releases, Press Releases|

Invivoscribe Expands Business into Solid Tumors with Assays and Services to Identify and Monitor CAR-T and TCR Immuno-Therapies

March 28th, 2017|2017 Press Releases, Press Releases|

Invivoscribe Expands Ion PGM NGS Platform Menu: Releases Additional CE-IVD Clonality Kits with Bioinformatics Software and RUO Kits with MRD Software

February 28th, 2017|2017 Press Releases, Press Releases|

Invivoscribe Announces Long-Term Collaboration Agreement with Illumina and Plans Release of NGS-based IVD Assay Kits

February 14th, 2017|2017 Press Releases, Press Releases|

Invivoscribe Expands Long-Term Collaboration Agreement to Release FLT3 Mutation and Clonality Assay Kits

January 31st, 2017|2017 Press Releases, Press Releases|

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.

Lymphoma

Myeloma

Browse our comprehensive menu of product & testing services.

A proven strategy to accelerate drug approvals

CE-IVD

Design Controls, Bioinformatics Software, Identify & Track, Custom Development, and Complementary MRD Assays

CE-IVD

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.

Measurable Residual FLT3 Internal Tandem Duplication Before Allogeneic Transplant for Acute Myeloid Leukemia

Measurable Residual FLT3 Internal Tandem Duplication Before Allogeneic Transplant for Acute Myeloid Leukemia

Assessment of Bone Marrow Involvement in B-Cell non-Hodgkin Lymphoma Using Immunoglobulin Gene Rearrangement Analysis with Next-Generation Sequencing

Evaluation of Next-Generation Sequencing Versus Next-Generation Flow Cytometry for Minimal Residual Disease Detection in Chinese Patients with Multiple Myeloma

Lymphoma

Myeloma

Lymphoma

Myeloma

Browse our comprehensive menu of product & testing services.

Press Releases

Press Releases

LATEST PRESS

PRESS RELEASES

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.

Personalized Molecular Medicine^® is use of genomics and patient specific information to identify optimal treatment for each patient.