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$The European Commission Approves Astellas’ XOSPATA® for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation Detected by Validated Tests, Including the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay$

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

SAN DIEGO, Dec. 5 (Korea Bizwire) — For twenty-five years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. The LeukoStrat® CDx FLT3 Mutation Assay may now be used as an aid in the assessment of AML patients for treatment with XOSPATA® (gilteritinib) [...]

Invivoscribe Expanding Clinical Laboratory Network Space and Testing Capabilities in San Diego, Germany, Japan, and China. Offering Comprehensive Standardized Testing for All Hematologic Malignancies

SAN DIEGO, May 21 (Korea Bizwire) — Invivoscribe, Inc., a vertically integrated global company focused on Improving Lives with Precision Diagnostics®, today announces expansion of space and testing capabilities in their international network of accredited LabPMM® clinical laboratories. Additions to the test menu will include morphology, IHC, flow cytometry, as well as the latest multiparameter [...]

Update — 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

SAN DIEGO, Nov. 29 (Korea Bizwire) — Invivoscribe is pleased to announce FDA approval of both the LeukoStrat CDx FLT3 Mutation Assay and the Astellas drug, XOSPATA (gilteritinib fumarate), for treatment of FLT3 positive refractory/relapse acute myeloid leukemia (AML) patients in the US. Further, the Japanese MHLW has confirmed national reimbursement for the LeukoStrat CDx [...]

Invivoscribe Submits LeukoStrat CDx FLT3 Mutation Assay both in the US and Japan to Support Daiichi Sankyo Submissions for Quizartinib

SAN DIEGO, Nov. 27 (Korea Bizwire) — In support of an ongoing partnership with Daiichi Sankyo, Invivoscribe is pleased to announce submissions of the LeukoStrat® CDx FLT3 Mutation Assay to both the US FDA and the Japan PMDA (Pharmaceuticals and Medical Devices Agency) as the companion diagnostic for quizartinib, which follows Daiichi Sankyo’s respective FDA [...]

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

SAN DIEGO, Nov. 19 (Korea Bizwire) — In support of an ongoing partnership with Daiichi Sankyo, Invivoscribe is pleased to announce submission of the LeukoStrat® CDx FLT3 Mutation Assay to the PMDA (Pharmaceuticals and Medical Devices Agency) as the companion diagnostic for quizartinib, which follows Daiichi Sankyo’s PMDA application for quizartinib in Japan. Invivoscribe developed [...]

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)

SAN DIEGO, Sept. 27 (Korea Bizwire) — Invivoscribe® Inc., a global company providing biomarker and clonality test solutions for the fields of oncology and personalized molecular medicine® today announces Pharmaceuticals and Medical Devices Agency (PMDA) approval of the LeukoStrat CDx FLT3 Mutation Assay companion diagnostic. As the first company to receive both FDA and PMDA [...]

Invivoscribe Releases the LymphoTrack Dx TRB Assay as CE-Marked IVD Kit, Completing the NGS Clonality Suite for the MiSeq Platform

SAN DIEGO, May 15 (Korea Bizwire) — Invivoscribe Technologies Inc., a global company with decades of experience providing clonality and biomarker test solutions for the fields of oncology and personalized molecular medicine, today announced the release of the LymphoTrack® Dx TRB Assay for the Illumina® MiSeq® platform, a CE-marked next-generation sequencing (NGS) assay kit for in [...]

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

SAN DIEGO, May 9 (Korea Bizwire) — Invivoscribe Technologies Inc., a global precision diagnostics company in oncology and personalized molecular medicine, announces a partnership with the American University of Beirut Medical Center (AUBMC) in Lebanon to create a new Center of Excellence. This facility will serve as an international service laboratory in the Middle East, testing [...]

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

SAN DIEGO, May 8 (Korea Bizwire) — Invivoscribe Technologies, Inc. announced today that they have submitted to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and the US Food and Drug Administration (FDA) product registrations based on the ongoing Phase III CL-0301 ADMIRAL study evaluating gilteritinib for the treatment of FLT3 mutation-positive (FLT3mut+) relapsed or refractory [...]

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

SAN DIEGO, Nov. 7 (Korea Bizwire) — Invivoscribe® Technologies Inc., a global company with decades of experience providing clonality and biomarker test solutions for the fields of oncology and personalized molecular medicine®, announces the release of the Research Use Only (RUO) version of its LymphoTrack® TRB Assay for the Illumina MiSeq® platform. Included with the assay is [...]