US Archives

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

2025-08-26T08:11:34-07:00May 19th, 2020|2020 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

2021-02-26T19:10:45-08:00May 21st, 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

2021-02-26T19:11:02-08:00November 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

2025-11-27T07:56:39-08:00November 27th, 2018|2018 Press Releases, Press Releases|

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

2021-02-26T19:11:48-08:00November 19th, 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

2021-02-26T19:12:23-08:00May 8th, 2018|2018 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

Browse our comprehensive menu of product & testing services.

Myeloma

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.

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

Browse our comprehensive menu of product & testing services.

Myeloma

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

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

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 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 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.

Lymphoma

Browse our comprehensive menu of product & testing services.

Myeloma

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.

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

Browse our comprehensive menu of product & testing services.

Myeloma

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

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

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

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 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.

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

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