Improving Lives with Precision Diagnostics^®

Dear Colleagues:

I am pleased to take this opportunity to highlight a few of our company’s accomplishments from last year and identify a few of the many projects we will address in the coming year.

The pandemic that became apparent to us in the first quarter of 2020 understandably had a significant impact on our entire international staff and all of our customers worldwide last year. However, our executive and human resources team anticipated and prepared for teams working offsite, and our supervisors, LabPMM clinical, and Invivoscribe teams worldwide rapidly implemented and adjusted to new workflows, new schedules to address social distancing on site, and working with their families to adjust to keeping our business processes and momentum going while working from home. So, despite COVID-19-precipitated challenges, Invivoscribe remained focused and productive, completing, on time, projects for our partners, advancing internal projects, all combining to achieve high double-digit year over year revenue growth for the company. 

To highlight just a few of the accomplishments our team members achieved in 2020:

To offer timely screening for our onsite employees, as well as to expand test availability in our local community, our team at LabPMM launched RT-qPCR COVID-19 testing at our CLIA/CAP, NY State Licensed reference laboratory in San Diego, CA.

Invivoscribe (IVS) received FDA regulatory approval for LeukoStrat^® CDx FLT3 Mutation Assay as a distributable kit, providing customers with a choice to use this internationally-standardized signal ratio assay for in-house testing.  The ability to perform efficient, accurate, and objective FLT3 testing at regional laboratories, cancer treatment centers, and hospitals is expected to improve the management of patients diagnosed with acute myelogenous leukemia (AML).

We completed the buildout and launch of our wholly-owned laboratory in Shanghai, China. The laboratory was completed, equipped, and staff were hired and trained just as the pandemic was starting to impact travel, so tours of our new facility and opening ceremonies were done remotely. The lab personnel expand and complement our international LabPMM team beyond the staff in the US, Germany and Japan. Testing is already underway, and will soon offer the entire menu of PCR capillary assays, NGS tests, gene panels, bioinformatics, and multiparameter flow cytometry screening and MRD panels that will also be offered in LabPMM laboratories around the world.

Our new drug development entity, Invivoscribe Therapeutics, in-licensed a small molecule program from a UK based drug discovery service provider Domainex. This program has a first in class compounds that target novel pathways critical for myeloid malignancies like AML. Invivoscribe Therapeutics has already advanced the program to define the therapeutic rationale using pharmacology models and in vitro testing using primary tumor specimens from patient samples. GLP studies and compound manufacturing for clinic are on track. As a part of pipeline expansion, we are now actively conducting diligence to in-license a second program that is Phase 2 ready.

Invivoscribe expanded its R&D team in San Diego by 30% to develop a variety of assays. We furthered our collaboration with a number of clinical pharmaceutical partners using LymphoTrack IGH and TCR assays to support minimal residual disease (MRD) detection in international clinical studies of a wide range of hematologic malignancies, including multiple myeloma (MM), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), peripheral T-cell lymphomas (PTCL).  A number of scientific papers and posters were also published or presented by clinical cancer centers using LymphoTrack MRD assays.

Our flow cytometry team, working in concert with our clinical laboratories and our therapeutics division, developed screening and viability assays for a variety of hematologic malignancies as well as a standardized MRD panel to track AML. These panels will be available both in San Diego and China starting early this year and will be used for both internal and external drug development projects. We expanded collection, flow and genomic cataloging and viable freezing of primary tumor specimens for in vitro drug viability, drug panel screening, and IC₅₀ drug studies.

Our bioinformatics team, working with our flow team and under direction of our chief medical officer, developed and presented new machine learning algorithms to facilitate and complement manual interpretation of flow cytometry data by hematopathologists. Initial data from the algorithms were presented by an online seminar at AMP.

We developed novel gene expression assays for ABI7500 Dx platform to support internal and external pharmaceutical partners, and we are developing 2^nd generation MyAML^® and MyMRD^® gene panels with more genes and better sensitivity to discover and monitor variants such as TP53 in myeloid malignancies including acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN) and myelodysplastic syndromes (MDS).

Finally, as always, I want to acknowledge that our growth and progress over these past 26 years would not be possible without your feedback and support. We look forward to continued interaction with research and clinical colleagues to ensure we can continue to offer you the best products for decades to come. We wish you, your colleagues, and your families a safe, joyful, productive, and successful 2021.

Sincerely Yours,

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