Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United Statesadmin2020-05-19T16:22:45+00:00May 19th, 2020|Categories: Press Releases|Tags: 3500xL Dx Genetic Analyzer, Acute Myelogenous Leukemia, Acute Myeloid Leukemia, AML, Analysis Software, Commercial Companion Diagnostics, Companion Diagnostics, D835, FDA Approval, FLT3 mut + AML Patients, FLT3 Mutation Test, Gilteritinib Fumarate, I836, In vitro Diagnostic Test, Internal Tandem Duplication, Invivoscribe, ITD, IVD Kit, LabPMM, LeukoStrat® CDx FLT3 Mutation Assay, Midostaurin, PCR-Based, Precision Diagnostics, Quizartinib, Quizartinib Hydrochloride, Relapsed/Refractory, Rydapt®, TKD, Tyrosine Kinase Domain, United States, US, Xospata®| ⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...] 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.admin2020-05-12T17:03:17+00:00May 12th, 2020|Categories: Press Releases|Tags: ADMIRAL, AML, Astellas, Australia, CE-Marked, China, Clinical Trials, Companion Diagnostics, Europe, FLT3 biomarker, Germany, gilteritinib, Invivoscribe, Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd., ITD, Japan, LabPMM, LeukoStrat® CDx FLT3 Mutation Assay, NMPA, QuANTUM-R, RATIFY, refractory FLT3-mutated AML, relapsed FLT3-mutated AML., Rydapt®, Shanghai, Switzerland, TKD, United States, VANFLYTA®, Xospata®| ⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...] 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 Japanadmin2020-05-29T00:00:58+00:00November 29th, 2018|Categories: Press Releases|Tags: Acute Myelogenous Leukemia, Acute Myeloid Leukemia, AML, Analysis Software, Commercial Companion Diagnostics, Companion Diagnostics, FDA Approval, FLT3 mut + AML Patients, FLT3 Mutation Test, Gilteritinib Fumarate, I836, In vitro Diagnostic Test, Internal Tandem Duplication, Invivoscribe, ITD, IVD Kit, LabPMM, LeukoStrat® CDx FLT3 Mutation Assay, Midostaurin, PCR-Based, Precision Diagnostics, Quizartinib, Quizartinib Hydrochloride, Relapsed/Refractory, Rydapt®, TKD, Tyrosine Kinase Domain, United States, US, Xospata®| ⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...] 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 AMLwmm2019-07-04T21:16:10+00:00April 28th, 2017|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, CDx, Companion Diagnostics, FDA, FDA Approval, LeukoStrat, LeukoStrat® CDx FLT3 Mutation Assay, Rydapt®| ⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...] Read More
