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| Read more
Invivoscribe Submits LeukoStrat® CDx FLT3 Mutation Assay to NMPA in China and Expands Company, Adding Laboratory in Shanghai to Provide Comprehensive Support for Partners. 2021-02-26T19:10:05-08:00May 12th, 2020|2020 Press Releases, Press Releases| Read more
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 2021-11-14T22:08:08-08:00December 5th, 2019|2019 Press Releases, Press Releases| Read more
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 2021-02-26T19:10:37-08:00June 19th, 2019|2019 Press Releases, Press Releases| Read more
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| Read more
Invivoscribe To Present At Biotech Showcase™ 2019 In San Francisco 2021-02-26T19:10:54-08:00January 3rd, 2019|2019 Press Releases, Press Releases| Read more
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 2021-02-26T19:11:02-08:00November 29th, 2018|2018 Press Releases, Press Releases| Read more
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| Read more
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| Read more
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) 2025-11-26T15:29:44-08:00September 27th, 2018|2018 Press Releases, Press Releases| Read more
Invivoscribe Announces a Regional “Center of Excellence” Reference Laboratory in Beirut to Offer Specialized Gene Panels 2021-02-26T19:12:15-08:00May 9th, 2018|2018 Press Releases, Press Releases| Read more
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| Read more
Invivoscribe® Releases LymphoTrack® TRB Assay on MiSeq® and LymphoTrack® Minimal Residual Disease (MRD) Software 2021-02-26T19:12:40-08:00November 7th, 2017|2017 Press Releases, Press Releases| Read more
Invivoscribe® Releases LeukoStrat® CDx FLT3 Mutation Assay as CE-marked IVD Assay Kit. 2021-02-26T19:12:46-08:00August 1st, 2017|2017 Press Releases, Press Releases| Read more
FDA approves new combination treatment for acute myeloid leukemia 2021-02-26T19:12:55-08:00April 28th, 2017|2017 Press Releases, Press Releases| Read more
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 2021-02-26T19:13:02-08:00April 28th, 2017|2017 Press Releases, Press Releases| Read more
Invivoscribe Expands Business into Solid Tumors with Assays and Services to Identify and Monitor CAR-T and TCR Immuno-Therapies 2021-02-26T19:13:49-08:00March 28th, 2017|2017 Press Releases, Press Releases| Read more
Invivoscribe Expands Ion PGM NGS Platform Menu: Releases Additional CE-IVD Clonality Kits with Bioinformatics Software and RUO Kits with MRD Software 2021-02-26T19:13:58-08:00February 28th, 2017|2017 Press Releases, Press Releases| Read more
Invivoscribe Announces Long-Term Collaboration Agreement with Illumina and Plans Release of NGS-based IVD Assay Kits 2021-02-26T19:14:04-08:00February 14th, 2017|2017 Press Releases, Press Releases| Read more
Invivoscribe Expands Long-Term Collaboration Agreement to Release FLT3 Mutation and Clonality Assay Kits 2021-02-26T19:14:11-08:00January 31st, 2017|2017 Press Releases, Press Releases| Read more
Novartis drug PKC412 (midostaurin) granted FDA Priority Review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis 2021-02-26T19:14:23-08:00November 14th, 2016|2016 Press Releases, Press Releases| Read more
Ion Torrent Developers Alliance Program Designed to Speed Targeted NGS Assay Development 2021-02-26T19:14:30-08:00May 31st, 2016|2016 Press Releases, Press Releases| Read more
German Supreme Court Upholds and Strengthens Invivoscribe FLT3 Patent Position 2021-02-26T19:14:37-08:00March 28th, 2016|2016 Press Releases, Press Releases| Read more
Novartis drug PKC412 (midostaurin) receives Breakthrough Therapy designation from the FDA for newly-diagnosed FLT3-mutated acute myeloid leukemia (AML) 2021-02-26T19:14:49-08:00February 18th, 2016|2016 Press Releases, Press Releases| Read more
Invivoscribe Announces Long-Term Collaboration to Develop Immuno-Oncology Tests With Thermo Fisher Scientific 2021-02-26T19:15:19-08:00February 9th, 2016|2016 Press Releases, Press Releases| Read more
