Invivoscribe® Launches LeukoStrat® KMT2A + MRD Assay to Advance High-Sensitivity Leukemia Testing in Clinical Trials and Patient Management Worldwide
Invivoscribe, a leader in precision medicine and measurable residual disease (MRD) testing, today announced the addition of the LeukoStrat® KMT2A + MRD Assay and Software to its industry-leading oncology portfolio. The assay leverages digital PCR (dPCR) to support both screening and precise longitudinal MRD monitoring for KMT2A rearrangements in acute myeloid leukemia (AML) subjects. This quantitative test is currently available for research use in clinical trials and as a stand-alone kit for purchase by our global customers, and will soon be available as a service in our regional LabPMM® laboratories worldwide.
LabPMM® Receives New York State Approval for the NPM1 MRD Assay - Informing Therapy and Accelerating Targeted Trials
Invivoscribe is happy to announce that its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine® (LabPMM) has received approval from New York State (NYS) for the NPM1 MRD Assay. This approval comes just two months after gaining NYS approval for our FLT3 ITD MRD Assay. Together these tests represent a critical tool for patients with acute myeloid leukemia (AML), clinicians and pharmaceutical companies. This new approval underscores Invivoscribe’s ongoing commitment to providing the most accurate, standardized measurable residual disease (MRD) testing solutions worldwide.
Invivoscribe’s LabPMM Gains New York State Approval for the FLT3 ITD MRD Assay
Invivoscribe is proud to announce that its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine® (LabPMM), LLC has received approval from the New York State Department of Health to offer the FLT3 ITD MRD Assay to assess measurable residual disease (MRD). LabPMM’s ultra-sensitive next generation sequencing FLT3 ITD MRD Assay provides clinicians with critical insights to tailor acute myeloid leukemia (AML) treatments and improve patient outcomes.
Invivoscribe Announces Registration of the LeukoStrat® CDx FLT3 Mutation Assay in the United Kingdom and Switzerland
Invivoscribe, a global leader in precision diagnostics, is pleased to announce the successful listings of the LeukoStrat CDx FLT3 Mutation Assay in both the United Kingdom (UK) and Switzerland. The LeukoStrat CDx FLT3 Mutation Assay aids in the accurate detection of FLT3 mutations, empowering clinicians to make informed treatment decisions. This milestone ensures expanded accessibility of critical treatments to patients diagnosed with acute myeloid leukemia (AML).
EU Notified Body (BSI Netherlands) and the EMA Grant Approval of the LeukoStrat® CDx FLT3 Mutation Assay for VANFLYTA® Therapy in the EU and EEA
Invivoscribe is excited to announce that their CE-2797 IVD certified LeukoStrat® CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA to aid in the selection of individuals in the European Union and European Economic Area with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo’s VANFLYTA® (quizartinib). BSI, a Notified Body accredited in the EU, is authorized to assess and certify In-Vitro Diagnostics (IVDs), ensuring product compliance with European directives and regulations.
Study Suggests Critical Link Between Residual FLT3-ITD Mutations in Remission and Post-Transplant Outcomes in AML
A groundbreaking research study,1 sequencing DNA samples from the Pre-MEASURE study2 strongly indicates that the detection of residual FLT3 internal tandem duplication (ITD) mutations in the blood of adult subjects with acute myeloid leukemia (AML) in first complete remission (CR) is associated with worse outcomes after post allogeneic hematopoietic cell transplant (HCT).
Invivoscribe Launches Grant Program to Support Novel Applications for Sequence-Based Analyses of the Immune System
Invivoscribe, a global leader in precision diagnostics, has announced the launch of an Immune Biomarker Discovery grant program, focused on supporting development, validation and deployment of novel applications for use of their distributed LymphoTrack® NGS products and bioinformatics software.
Invivoscribe Premieres 12-Color Flow Cytometry Capabilities at their Reference Labs in the US, Europe, and China
Today Invivoscribe, a global leader in precision diagnostics, announced the launch of a new 12-color multiparametric flow cytometry service in Shanghai, China, the newest reference laboratory in their international LabPMM network. Flow cytometry has long been the standard of care for many blood cancers including acute myeloid leukemia (AML), but to achieve minimal residual disease (MRD) level sensitivity with limited specimen, powerful 12-color multiparametric flow cytometry (MFC) is needed. By providing the combination of 12-color flow cytometry and next-generation sequencing (NGS) MRD capabilities in the US, in Europe, and also in China, Invivoscribe now offers a comprehensive international solution for our pharma partners.
