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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

Invivoscribe Marketing2021-02-26T19:11:02-08:00November 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

Invivoscribe Marketing2022-09-23T16:52:06-07:00November 27th, 2018|2018 Press Releases, Press Releases|

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

Invivoscribe Marketing2021-02-26T19:11:48-08:00November 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)

Invivoscribe Marketing2021-02-26T19:12:02-08:00September 27th, 2018|2018 Press Releases, Press Releases|

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

Invivoscribe Marketing2021-02-26T19:12:15-08:00May 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

Invivoscribe Marketing2021-02-26T19:12:23-08:00May 8th, 2018|2018 Press Releases, Press Releases|

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

wmm2021-02-26T19:12:40-08:00November 7th, 2017|2017 Press Releases, Press Releases|

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

wmm2021-02-26T19:12:46-08:00August 1st, 2017|2017 Press Releases, Press Releases|

FDA approves new combination treatment for acute myeloid leukemia

wmm2021-02-26T19:12:55-08:00April 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

wmm2021-02-26T19:13:02-08:00April 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

wmm2021-02-26T19:13:49-08:00March 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

wmm2021-02-26T19:13:58-08:00February 28th, 2017|2017 Press Releases, Press Releases|

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

wmm2021-02-26T19:14:04-08:00February 14th, 2017|2017 Press Releases, Press Releases|

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

wmm2021-02-26T19:14:11-08:00January 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

wmm2021-02-26T19:14:23-08:00November 14th, 2016|2016 Press Releases, Press Releases|

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

wmm2021-02-26T19:14:30-08:00May 31st, 2016|2016 Press Releases, Press Releases|

German Supreme Court Upholds and Strengthens Invivoscribe FLT3 Patent Position

wmm2021-02-26T19:14:37-08:00March 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)

wmm2021-02-26T19:14:49-08:00February 18th, 2016|2016 Press Releases, Press Releases|

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

wmm2021-02-26T19:15:19-08:00February 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

wmm2021-02-26T19:16:48-08:00December 5th, 2015|Archived 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.

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.