INVIVOSCRIBE INC.

Company Overview

Invivoscribe Inc., founded in 1995, develops and markets in vitro molecular diagnostics, analyte-specific reagents and research-use-only reagents. Invivoscribe’s products are focused on hematology/oncology and include assays for identifying clonal gene rearrangements, gene translocations and gene mutations in patients with putative lymphoproliferations. Invivoscribe’s assays run on NGS and capillary electrophoresis platforms.

Invivoscribe markets LymphoTrack (available as RUO) and LymphoTrack Dx (available as CE-IVD) assays that use MiSeq or Ion PGM NGS platforms to identify and track clonal lymphocyte populations. This test examines clonal rearrangements in TRG V-J and IGH V-J.

In the field of cancer diagnostics, Invivoscribe has developed its MyMRD assay, which provides NGS-based monitoring of residual disease using cfDNA. The panel is offered as research-use-only and identifies mutation hotspots in 23 genes associated with acute myeloid leukemia (AML).

The MyAML test analyzes the exons of 194 genes as well as 36 hotspot mutations in intronic regions that are likely to have breakpoints for gene fusions. Informatics for the test are run on the MyInformatics platform. The test is performed at the Laboratory for Personalized Molecular Medicine, which is a subsidiary of Invivoscribe and is CLIA-certified.

A second test that is offered as a service is MyHeme, which uses NGS to analyze more than 700 genes related to hematological malignancies.

In May 2020, the LeukoStrat CDx FLT3 Mutation Assay received supplemental approval from the FDA; it provides customers a choice to purchase the IVD-labeled test kit for in-house testing. The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test that detects internal tandem duplication and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with AML.

In July 2023, company announced FDA approval of its product LeukoStrat CDx FLT3 Mutation Assay, which is to be used for selecting patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) and who are eligible to take Daiichi Sankyo’s VANFLYTA (quizartinib) for treatment.

Company's Business Segments

• Oncology : The company offers a broad range of oncology products and services developed under ISO 13485 design control and manufactured in its cGMP facility.