Improving Lives with Precision Diagnostics^®

Dear Colleagues:

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.

IVS participated in over 30 conferences and tradeshows worldwide, presenting 8 posters and publishing 2 scientific papers with participation from our R&D, LabPMM and bioinformatics groups. A number of scientific papers and posters were also published or presented by customers using our products.

IVS launched MRD controls for both B- and T-cell assays with our comprehensive suite of LymphoTrack Clonality Assays, including LymphoTrack^® software for Illumina^® NGS platforms. These assays identify and track clonal rearrangements within the antigen receptor loci (IGH, IGK, TRG, TRB). The 24 ID format (48 indices for the IGH FR1 assay) allows customers to significantly reduce costs, as users can run any combination of the 7 assays (up to 178 samples with 14 controls) simultaneously on one chip, as the accompanying bioinformatics software automatically sorts and interprets the data for each targeted region and sequence ID. These RUO assays are being used with accompanying minimal residual disease (MRD) bioinformatics software in international studies of a wide range of hematologic malignancies, including multiple myeloma and acute lymphoblastic leukemia. The assays will be submitted for review via the US FDA’s 510(k) process and with the appropriate regulatory authorities worldwide.

We also finished development of a TRG MiSeqDx 510(k) assay; released LymphoTrack^® Dx assays for ThermoFisher NGS platforms, and started working under an exclusive agreement with the BIOMED-2 /EuroClonality Consortium in Europe to develop and commercialize their NGS-based assays.

In addition, we made substantial progress building out a new wet lab in Shanghai to add further capabilities for clinical programs to support our pharma partners in China, expanded operations and capabilities at our clinical labs in the US, Japan, the EU, and established an entirely new line of business: setting up a flow cytometry lab so we can soon offer both flow- and NGS-based MRD testing intramurally on exactly the same primary specimens.

We developed a number of engineered cell lines using CRISPR technology, a highly sensitive assay on a digital droplet PCR platform, and filed a number of patents. Still further, we launched a wholly-owned drug development company, Invivoscribe Therapeutics, that has already started testing a small molecule that targets myeloid malignancies.

In 2019 our entire range of tests, including MyAML^®, and MyMRD^® gene panels with our MyInformatics^® bioinformatics pipeline, received increased traction and use by more than three dozen pharmaceutical partners. These tests are available as RUO and/or CLIA/CAP listed tests through our LabPMM clinical laboratories in the USA, Europe, and Asia.

Finally, I want to acknowledge that our continued growth and progress over these past 25 years would not be possible without our customer’s feedback and support. We look forward to continued interaction with the research and clinical communities so we can offer you the best products for decades to come and we wish you, your colleagues, and your families a joyful, productive, and successful 2020.

Sincerely Yours,

Jeffrey Edward Miller, Ph.D.
Founder, Chief Scientific Officer, Chief Executive Officer & Chairman