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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 IVDR Approval of the LeukoStrat CDx FLT3 Mutation Assay

Invivoscribe Marketing2023-05-11T03:12:47-07:00May 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

Invivoscribe Marketing2023-02-23T06:28:40-08:00February 23rd, 2023|2023 Press Releases, Press Releases|

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

Invivoscribe Marketing2023-02-01T21:02:16-08:00February 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

wmm2022-10-24T14:57:12-07:00October 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

Invivoscribe Marketing2022-08-16T20:08:13-07:00August 16th, 2022|2022 Press Releases, Press Releases|

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

wmm2022-05-09T17:27:05-07:00May 9th, 2022|2022 Press Releases, Press Releases|

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

Invivoscribe Marketing2021-09-02T16:53:40-07:00September 2nd, 2021|2021 Press Releases, Press Releases|

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

Invivoscribe Marketing2021-07-22T17:27:56-07:00July 22nd, 2021|2021 Press Releases, Press Releases|

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

wmm2021-06-24T18:20:34-07:00June 24th, 2021|2021 Press Releases, Press Releases|

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

wmm2021-06-03T20:36:18-07:00June 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

Invivoscribe Marketing2021-02-26T19:09:52-08:00May 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.

Invivoscribe Marketing2021-02-26T19:10:05-08:00May 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

Invivoscribe Marketing2021-11-14T22:08:08-08:00December 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

Invivoscribe Marketing2021-02-26T19:10:37-08:00June 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

Invivoscribe Marketing2021-02-26T19:10:45-08:00May 21st, 2019|2019 Press Releases, Press Releases|

Invivoscribe To Present At Biotech Showcase™ 2019 In San Francisco

wmm2021-02-26T19:10:54-08:00January 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

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|

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

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.

November 17th, 2020 Routine Evaluation of Minimal Residual Disease in Myeloma Using Next-Generation Sequencing Clonality Testing

April 20th, 2021 Validation of a Next-Generation Sequencing-based T-Cell Receptor Gamma Gene Rearrangement Diagnostic Assay: Transitioning from Capillary Electrophoresis to Next-Generation Sequencing

November 17th, 2020 Routine Evaluation of Minimal Residual Disease in Myeloma Using Next-Generation Sequencing Clonality Testing

Lymphoma

Myeloma

Browse our comprehensive menu of product & testing services.

Title

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.

November 17th, 2020
Routine Evaluation of Minimal Residual Disease in Myeloma Using Next-Generation Sequencing Clonality Testing

April 20th, 2021
Validation of a Next-Generation Sequencing-based T-Cell Receptor Gamma Gene Rearrangement Diagnostic Assay: Transitioning from Capillary Electrophoresis to Next-Generation Sequencing

November 17th, 2020
Routine Evaluation of Minimal Residual Disease in Myeloma Using Next-Generation Sequencing Clonality Testing