Invivoscribe offers a full range of oncology testing products and services (B- and T-cell clonality, NGS gene panels, MRD assays, and comprehensive bioinformatics software), all developed under ISO 13485 design control and manufactured in our cGMP facility.
I am pleased to take this opportunity to share some of last year’s accomplishments.
Total year over year revenue grew over 30%, supported by new tests, menu items, adoption of our suite of LymphoTrack® assays that include bioinformatics software, and our LeukoStrat® FLT3 CDx Mutation Assay.
Invivoscribe (IVS) received several regulatory approvals for the internationally-standardized FLT3 signal ratio test, including approval of the CDx claim for quizartinib in Japan. We submitted a CDx distributable kit package to the US FDA so we anticipate we will be able to sell a FLT3 CDx kit in the US later this year. We also finalized several new CDx partnership projects: one for a new CDx assay on the 7500 Fast Dx instrument, and one with a previous partner. We will announce these deals early in 2020.