Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United StatesInvivoscribe Marketing2021-02-26T19:09:52-08:00May 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.Invivoscribe Marketing2021-02-26T19:10:05-08:00May 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 AssayInvivoscribe Marketing2021-11-14T22:08:08-08:00December 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 EDTAInvivoscribe Marketing2021-02-26T19:10:37-08:00June 19th, 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 JapanInvivoscribe Marketing2021-02-26T19:11:02-08:00November 29th, 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)Invivoscribe Marketing2021-02-26T19:12:02-08:00September 27th, 2018|2018 Press Releases, Press Releases| Read more
A next-generation sequencing–based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutationsInvivoscribe Marketing2021-02-11T23:49:39-08:00August 25th, 2018|2018 Publications, Featured Publications, Publications| 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 MutationsInvivoscribe Marketing2021-02-26T19:12:23-08:00May 8th, 2018|2018 Press Releases, Press Releases| Read more
FDA approves new combination treatment for acute myeloid leukemiawmm2021-02-26T19:12:55-08:00April 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 AMLwmm2021-02-26T19:13:02-08:00April 28th, 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 mastocytosiswmm2021-02-26T19:14:23-08:00November 14th, 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)wmm2021-02-26T19:14:49-08:00February 18th, 2016|2016 Press Releases, Press Releases| Read more
Novartis drug PKC412 (midostaurin) improves overall survival by 23% in global Phase III study of AML patients with FLT3 mutationswmm2021-02-26T19:16:48-08:00December 5th, 2015|Archived Press Releases, Press Releases| Read more