Improving Lives with Precision Diagnostics^®

Dear Colleagues:

I am pleased to introduce Invivoscribe’s 2022 Product Catalog.  As in years past, I am taking this opportunity to highlight a few of our company’s many accomplishments in 2021 and identify a few
of the many projects we will address in the coming year.

To highlight just a few of the accomplishments our team members achieved in 2021:

Invivoscribe evolved its Quality Management System (QMS) to meet the IVDR requirements and submitted the first class C CDx package for IVDR review to our notified body, helping cement our role as a leader in ensuring state of the art targeted therapies are supported in the EU.

Invivoscribe’s software and bioinformatics teams finalized development and launched updated MRD Software that allows simultaneous tracking of up to five separate biomarkers using our LymphoTrack^® assays.

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 in a supplemental issue of Blood and in a poster at ASH.

We began work on moving bioinformatics software pipeline and reporting features to the cloud. When complete, we expect our portal will revolutionize and expand our commercial platform, providing access to bioinformatics pipeline and software for data analysis, interpretation for pharma partners and customers worldwide. In addition, we have started licensing an enterprise version of Invivoscribe’s LymphoTrack^® Software to streamline data management at key cancer centers.

Invivoscribe expanded R&D, bioinformatics and software teams in San Diego in order to develop
a variety of assays and 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. We had 34 peer-reviewed scientific papers published by global customers conducted using Invivoscribe products and participated in 13 international conferences.

LabPMM, our international clinical laboratory arm, expanded capabilities across sites via obtaining CAP/CLIA listing for flow in the US, validating additional flow lab and molecular testing capabilities
in China, moving our EU lab to a larger more sophisticated facility in Munich, and submitting for ISO 15189 accreditation in Japan.  This year we will be offering an even more complete menu of PCR capillary assays, NGS tests, gene panels, bioinformatics, and multiparameter flow cytometry screening and MRD panels to support clinical and pharma partners in the LabPMM laboratories around
the world.

Our flow cytometry team developed screening assays for hematologic malignancies. The CLIA-accredited 10-color Hematolymphoid Screening Panel provides a comprehensive approach
to evaluate bone marrow and peripheral blood for the presence or absence of hematolymphoid malignancies. The team also developed and launched a 12-color flow MRD test for AML that tracks
21 biomarkers. These panels are currently being run in San Diego, but reagent set and software validations with the addition of cGMP manufacturing ensure that we can make these assays available in China and other LabPMM sites in the near future.

We are developing a pan cancer gene panel, and 2nd generation MyAML^® and MyMRD^® gene panels with more genes and better sensitivity to identify and monitor variants such as TP53 in solid tumors, myeloid malignancies, including acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), and myelodysplastic syndromes (MDS).

Some key Invivoscribe and LabPMM milestones that will be met this year include:

The team will be submitting for CAP accreditation of our Shanghai laboratory; finishing our ISO 15189 accreditation for our lab in Japan; earning our IVDR QMS accreditation at our San Diego headquarters; receiving LeukoStrat CDx FLT3 Mutation Assay approval through the new IVDR system in the EU; and generating IVDR validation packages for multiple capillary and NGS assays in the queue for submission to our notified body.  Additionally, we will be finalizing development and release an NGS-based B-cell MRD Assay, an MRD Myeloid Assay, and machine learning algorithms to assist in streamlining flow analyses in our clinical laboratories worldwide.

Finally, I want to acknowledge that our growth and progress over these past 27 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 2022.

Sincerely Yours,

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