CAREDX INC.

Company Overview

CareDx Inc. is developing and marketing diagnostics monitoring assays for transplant patients. The company operates through two business segments: Post-Transplant Diagnostics and Pre-Transplant Diagnostics.

The Post-Transplant Diagnostics business markets AlloMap (a heart transplant molecular test) and AlloSure (a cfDNA-based liquid biopsy test for kidney transplant patients). The Pre-Transplant Diagnostics business segment markets products that facilitate a match between a donor and recipient. This business sells Olerup SSP (types human leukocyte antigen alleles), Olerup SBT (sequencing-based HLA typing) and XM-ONE (identifies pathogens against HLA Class I or Class II).

In May 2018, CareDx and Illumina formed a licensing partnership covering rights to Illumina’s NGS platforms for transplant clinical applications. CareDx became the exclusive distributor of Illumina’s TruSight HLA v1 and v2 products and associated Assign HLA software. CareDx also has exclusive rights to develop and commercialize the next generation (v3) of the HLA product lines for bone marrow and solid organ transplant testing. CareDx will market these products under the AlloSeq HLA, AlloSeq BMT and AlloSeq cfDNA product names.

AlloSeq is a kit-based product that is used to quantify the level of donor-derived cell-free DNA in transplant recipients so as to measure graft health; the test is run on NGS platforms.

In May 2020, CareDx formed a strategic alliance with Veracyte to commercialize its organ transplant rejection tests on Veracyte’s nCounter Flex analysis diagnostic platform.

In November 2020, the Medicare Administrative Contractor CGS Administrators released a local coverage determination aligning with Palmetto GBS’s expanded decision to cover CareDx’s AlloSure tests for organ transplants. Earlier, in October 2020, this test received a final local coverage determination from Medicare contractor Palmetto GBA.

In January 2020, CareDx received the CE Mark for its AlloSeq cfDNA kit; this made the kit available to transplant patients and clinicians in Europe.

In May 2020, CareDx formed a partnership with Weill Cornell Medicine to develop and commercialize UroMap, a urine-based gene expression test for acute cellular rejection in kidney transplant recipients. The agreement is a multiyear research collaboration including exclusive rights to bring UroMap to patients. CareDx has an exclusive right to the UroMap technology by virtue of a license agreement with Cornell University.

In May 2020, CareDx’s AlloSeq Tx17 HLA typing test received the CE marking, making it possible to access European customers.

In June 2020, CareDx formed a strategic alliance with Seven Bridges, a leading bioinformatics ecosystem provider, supporting the CareDx AlloSure 3.0 workflow. AlloSure is a liquid biopsy dd-cfDNA test for kidney transplant surveillance. The use of the Seven Bridges platform is thought to speed time to results by streamlining analysis workflows, minimizing the number of manual steps required to set up, run and conclude an analysis.

In January 2021, the French National Blood Service, Etablissement Francais du Sang (EFS) selected AlloSeq HCT as the primary solution for chimerism monitoring of stem cell transplant patients. This is the first NGS-based chimerism solution approved by the EFS. This marked the first entry by CareDx into the cell transplant monitoring market, providing an opportunity for NGS beyond organ transplantation.

Financial Highlights (FY 2023)

Company's Business Segments

• Testing services revenue : AlloSure Kidney, AlloMap Heart, AlloSure Heart, AlloSure Lung, Cellular Therapy
• Product revenue : AlloSeq Tx, QTYPE, Olerup SSP, AlloSeq HCT, AlloSeq cfDNA
• Patient and digital solutions : This segment provides various software solutions such as Ottr and XynManagement. The Ottr software enables integration with electronic medical records, or EMR, systems, including Cerner and Epic, providing patient surveillance management tools and outcomes data to transplant centers. XynManagement provides two unique solutions, XynQAPI software, or XynQAPI, XynCare.