CareDx, Inc (CareDx), precision medicine company, focuses on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients and caregivers.
The company offers testing services, products, and patient and digital solutions along the pre- and post-transplant patient journey, and it is a leading provider of genomics-based information for transplant patients. The company’s primary operations are in Brisbane, California; Omaha, N...
CareDx, Inc (CareDx), precision medicine company, focuses on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients and caregivers.
The company offers testing services, products, and patient and digital solutions along the pre- and post-transplant patient journey, and it is a leading provider of genomics-based information for transplant patients. The company’s primary operations are in Brisbane, California; Omaha, Nebraska; and Stockholm, Sweden.
As of December 31, 2024, substantially all of the company’s revenues came from the United States and Europe, and substantially all of its assets and operations were located in the United States and Sweden.
Growth Strategy
CareDx’s strategic priorities are to accelerate profitable growth; define TRANSPLANT+ and expand the company’s total addressable market; and elevate performance.
Products and Services
The company’s commercially available post-transplant testing services consist of AlloSure Kidney, a donor-derived cell-free DNA, or dd-cfDNA, solution for kidney transplant patients; AlloMap Heart, a gene expression profiling solution for heart transplant patients; AlloSure Heart, a dd-cfDNA solution for heart transplant patients; and AlloSure Lung, a dd-cfDNA solution for lung transplant patients. The company has initiated several clinical studies to generate data on its existing and planned future testing services. It has signed multiple biopharma research partnerships for AlloCell, a surveillance solution that monitors the level of engraftment and persistence of allogeneic cells for patients who have received cell therapy. The company also offers high-quality products in the pre-transplant space that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. Additionally, it provides digital transplant solutions and various offerings that help transplant centers with patient management, outcomes quality, and operational support. The company’s software solutions are currently used in over 170 transplant centers in the U.S.
The company also offers specialized pharmacy services for transplant patients. The pharmacy helps patients and caregivers access lifesaving medications by managing complex medication regimens, addressing side effects, and navigating the billing process.
Testing Services
The company develops and provides diagnostic testing services for solid organ transplant recipients, hematopoietic stem cell transplant recipients, and recipients of cell therapies. During 2024, it performed more than 175,000 commercial tests from its Brisbane, California, laboratory.
The care of organ transplant recipients is an intense and costly effort, and it requires lifelong surveillance and management by highly specialized clinicians and other healthcare providers. Unsuccessful treatment of rejection can result in an additional transplant or, worse, the death of the patient.
The historical standard for transplant surveillance has been through functional tests and invasive biopsies to identify histopathological signs of rejection. Both types of testing had (and have) significant limitations:
Functional tests are recognized to be late indicators. Rejection is well known to occur even in the absence of clinical signs or symptoms, and damage may occur before organ function is impacted to the extent it is measurable by a functional test; and
Biopsies are invasive and risk damage to the organ, and infection from exposure to a medical setting for the procedure itself. They also present risks of mechanical problems, pain, and anxiety to the patient. These risks present an impediment to the usage of biopsies on a routine basis. In addition, biopsies may be difficult to access for patients in more rural settings distant from a transplant center where the procedure would be performed. Importantly, the diagnostic precision of biopsies is limited by sampling issues and interobserver variability. Finally, the interpretation of a biopsy relies on descriptive, empirically driven consensus classifications that change over time and frequently lack an etiologic basis.
AlloMap Heart
The company’s first product launched in 2005, AlloMap Heart, is an innovative gene expression profiling test intended to aid clinicians in the identification of heart transplant recipients with stable graft function who have a low probability of moderate-to-severe acute cellular rejection at the time of testing, in conjunction with standard clinical assessment.
The use of AlloMap Heart, in conjunction with other clinical indicators, can help healthcare providers and their patients better manage long-term care following a heart transplant, can improve patient care by helping healthcare providers avoid the use of unnecessary invasive surveillance biopsies, and may help to determine the appropriate dosage levels of immunosuppressants by measuring the activity of the immune system. AlloMap Heart has 510(k) clearance from the U.S. Food and Drug Administration for marketing and sales as a test in heart transplant recipients who have stable graft function at the time of testing, to aid in the identification of those who have a low probability of moderate/severe acute cellular rejection at the time of testing, in conjunction with standard clinical assessment.
AlloSure Heart
AlloSure Heart, the company’s dd-cfDNA heart transplant solution, is a molecular diagnostic test intended for the early detection of heart allograft injury and rejection. AlloSure Heart helps provide peace of mind that injury is unlikely when dd-cfDNA levels are low. AlloSure Heart is validated to detect all types of clinical rejection, including antibody-mediated rejection (AMR) and acute cellular-mediated rejection (ACR).
AlloSure Heart was developed specifically for transplant patients and is a non-invasive blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient’s heart allograft, known as donor-derived cell-free DNA (dd-cfDNA).
HeartCare
HeartCare combines the gene expression profiling technology of AlloMap Heart with the dd-cfDNA technology of AlloSure Heart in one surveillance solution. An approach to surveillance using HeartCare provides information from two complementary measures: AlloMap Heart – a measure of immune system status, and AlloSure Heart – a measure of graft injury.
HeartCare provides robust information about distinct biological processes, such as immune quiescence, active injury, acute cellular rejection, and antibody-mediated rejection.
AlloSure Kidney
AlloSure Kidney, the company’s kidney transplant solution, is a molecular diagnostic test intended for the early detection of kidney allograft injury and rejection. AlloSure Kidney is validated to detect all types of clinical rejection, including antibody-mediated rejection (ABMR) and T-cell mediated rejection (TCMR). AlloSure testing is reported as a continuous score, and the relative change value (RCV) between two independent longitudinal AlloSure tests has been validated to inform clinical decision-making when indicating a high likelihood of rejection.
In June 2024, a publication in the high-impact journal Nature Medicine described the ability of AlloSure to predict rejection in numerous scenarios, including subclinical rejection in stable patients. This same publication demonstrated that elevated levels of dd-cfDNA were highly associated with the presence, activity, and severity of all types of rejection, and showed its added value beyond standard of care monitoring in predicting rejection.
AlloSure Kidney was developed specifically for transplant patients and is a non-invasive blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient’s kidney allograft, known as donor-derived cell-free DNA (dd-cfDNA).
HistoMap Kidney
HistoMap Kidney, the company’s solution for kidney rejection identification and typing, is a gene expression profiling test intended to identify allograft rejection and type of rejection in kidney transplant biopsy tissue. Biopsy is the standard of care for kidney transplant patients suspected of rejection, either through molecular methods, like AlloSure Kidney, or due to signs and symptoms of rejection. HistoMap Kidney is being developed for use on formalin-fixed tissue samples from kidney biopsy to identify rejection and rejection type to enable clinical decision-making and appropriate therapy selection.
In 2023, a HistoMap validation study was published in the journal Laboratory Investigation, demonstrating its ability to accurately identify rejection and type as antibody-mediated rejection, cellular rejection, mixed rejection, or no rejection.
AlloSure Lung
AlloSure Lung, the company’s solution for lung transplant patients, is a leading indicator of injury and early rejection identification. AlloSure Lung may help guide physicians as to whether bronchoscopy and biopsy may be necessary. AlloSure Lung helps provide peace of mind that injury is unlikely when dd-cfDNA levels are low.
In April of 2022, a multicenter study of 175 patients published in the Journal of Heart and Lung Transplantation demonstrated that AlloSure Lung reduced surveillance bronchoscopies by 82%, and that AlloSure Lung can identify subclinical acute lung allograft dysfunction in stable patients without clinical signs and symptoms.
AlloSure Lung was developed specifically for transplant patients and is a non-invasive blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient’s lung allograft, known as donor-derived cell-free DNA (dd-cfDNA).
AlloHeme
AlloHeme, the company’s solution for stem cell transplantation, is an accurate and sensitive test for monitoring and early relapse detection for hematologic malignancies after allogeneic hematopoietic stem cell transplantation. By measuring small changes in mixed chimerism, AlloHeme may detect relapse a clinically meaningful time ahead of standard methods. In July 2021, the company launched the Assessing Chimerism and Relapse of Bone marrow/HCT transplant using AlloHeme Testing (ACROBAT) study. The ACROBAT study is a prospective, multicenter, observational cohort study to evaluate the use of AlloHeme, an NGS tool to predict post-transplant relapse in patients with allogeneic hematopoietic cell transplants, or HCT.
AlloCell
AlloCell, the company’s solution for cell therapy, such as CAR-T therapy, monitors the pharmacokinetics of engraftment and persistence of cells for patients who have received allogeneic cell therapy. AlloCell is currently being utilized in research partnerships with biopharma companies developing cell therapies. To date, the company has executed multiple agreements with biopharma therapeutics companies to use AlloCell in research and clinical studies.
Lab Products
The company accesses global markets through its RUO and CE-marked Lab Products. It develops, manufactures, markets, and sells products that increase the chance of successful transplants by facilitating a better match between a solid organ or stem cell donor and a recipient, and help provide post-transplant surveillance. The company’s Lab Product portfolio includes QTYPE, Olerup SSP and SBT, AlloSeq Tx, AlloSeq HCT, and AlloSeq cfDNA.
Distributed PCR Kits for HLA Typing
QTYPE enables Human Leukocyte Antigen, or HLA, typing at a low to intermediate resolution for samples that require a fast turnaround time and uses real-time polymerase chain reaction, or PCR, methodology. QTYPE primarily focuses on typing where rapid typing results are required, such as for deceased donor typing. Typing with QTYPE requires one hour compared to the up to 2-3 hours that it takes to do traditional SSP typing and the 5-7 hours that it takes with sequence-specific oligonucleotides, or SSO.
Olerup SSP is used to type HLA alleles based on the sequence-specific primer, or SSP, technology. The Olerup SSP product line comprises products for low to high-resolution HLA typing. The product line includes close to 170 different typing products. The company offers one of the most up-to-date and comprehensive libraries of HLA typing kits based on SSP technology.
Distributed NGS Kits for HLA Typing and Transplant Monitoring
The company’s distributed NGS products include: AlloSeq Tx, a high-resolution HLA typing solution; AlloSeq cfDNA, its surveillance solution designed to measure dd-cfDNA in blood to detect injury and active rejection in transplant recipients; and AlloSeq HCT, an NGS solution for chimerism testing for stem cell transplant recipients.
AlloSeq Tx is the first of its kind NGS high-resolution HLA typing solution utilizing hybrid capture technology. This technology enables the most comprehensive sequencing, covering more of the HLA genes than other solutions on the market, as well as non-HLA genes that may impact transplant patient matching and management. AlloSeq Tx17 received CE mark authorization in May 2020. AlloSeq Tx9 is a high-throughput version of AlloSeq Tx17 for HLA typing in high-volume laboratories. AlloSeq Tx9 received CE mark authorization in August 2022.
The company received CE mark authorization for AlloSeq cfDNA in January 2020. Clinical uptake for AlloSeq cfDNA will be a result of multiple factors, including product-specific evidence publications, local clinical education, customer lab technical proficiency, and levels of country-specific reimbursement.
AlloSeq HCT is an NGS solution for chimerism testing for stem cell transplant recipients. This technology has the potential to provide better sensitivity and data analysis compared to current solutions on the market. AlloSeq HCT received CE mark authorization in May 2022.
Patient and Digital Solutions
The company provides a diverse portfolio of digital solutions to transplant centers, including Ottr software, XynQAPI software, XynCare, AlloCare, AlloHome, TxAccess, MedAction Plan, The Transplant Pharmacy, or TTP, HLA Data Systems, and MediGO.
The company’s Ottr software consists of two unique offerings, Ottr Organ and Ottr Cellular, which provide comprehensive solutions for transplant patient management and enable integration with electronic medical records, or EMR, systems, including Cerner and Epic, providing patient surveillance management tools and outcomes data to transplant centers.
The company’s XynQAPI software simplifies transplant quality tracking and Scientific Registry of Transplant Recipients reporting, and its XynCare offering includes a team of transplant assistants who maintain regular contact with patients on the waitlist to help prepare for their transplant and maintain eligibility.
AlloCare is a mobile app that provides a patient-centric resource for transplant recipients to manage medication adherence, coordinate with Patient Care Managers for AlloSure scheduling, and measure health metrics.
AlloHome is a remote patient monitoring solution designed to drive patient engagement and timely interventions for patients pre- and post-transplant.
TxAccess is a cloud-based service that allows nephrologists and dialysis centers to electronically submit referrals to transplant programs and closely follow and assist patients through the transplant waitlist process, and ultimately through transplantation.
MedActionPlan provides medication safety, medication adherence, and patient education. MedActionPlan is a leader in patient medication management for transplant patients and beyond.
The company’s HLA Data Systems software solutions, which include mTilda, VxMatch, and VECTR, provide software and interoperability solutions for the histocompatibility and immunogenetics community.
The company’s MediGO solution provides access to donated organs by digitally transforming donation and transplantation workflows to increase organ utilization.
TTP consists of transplant-focused pharmacies located in Mississippi. TTP provides individualized transplant pharmacy services for patients at multiple transplant centers located throughout the U.S.
Testing Services Laboratory Operations
AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, and AlloSure Lung testing is performed in the company’s clinical laboratory, which is located in its Brisbane, California, location. The company’s laboratory holds a certificate of accreditation under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and is accredited by the College of American Pathologists, or CAP. The company’s laboratory capacity will be adequate to meet demand for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, and AlloSure Lung, and other tests in the development pipeline for the next few years.
There are two types of samples received at the laboratory. When AlloSure Kidney, AlloSure Heart, or AlloSure Lung is ordered by a clinician, a blood sample is drawn and sent overnight to the company’s laboratory. When a clinician orders AlloMap Heart, a blood sample is drawn, processed, and then sent via overnight courier to its laboratory. Regardless of the test requested, the test results are typically reported to the ordering clinician within two business days from receipt of the sample. Test samples that fail to meet quality control criteria and have enough remaining material are re-tested on the next available batch of samples, which may extend the turnaround time.
The company relies solely on certain suppliers to provide some of the laboratory instruments and key reagents that it uses to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, and AlloSure Lung testing. These sole-source suppliers include Thermo Fisher Scientific, Inc., or Thermo Fisher, which supplies it with instruments, laboratory reagents, and consumables; Roche Molecular Systems, which supplies it with laboratory reagents and consumables; Hamilton Robotics, which supplies equipment and consumables; Illumina, which supplies it with instruments, laboratory reagents, and consumables; Becton, Dickinson and Company, and Streck, which supply it with cell preparation tubes; Beckman Coulter, which provides laboratory equipment, reagents, and consumables; and Qiagen N.V., which supplies it with a proprietary buffer reagent.
Sales and Marketing
The company has organized its commercial sales and marketing teams to be customer-centric in a functional structure that is intended to unlock the potential of its synergistic portfolio of solutions and deliver the best experience for clinicians, patients, and administrators.
In the U.S., the organization and delivery of healthcare, including for transplantation, is highly local. To first and foremost empower local teams to devise effective tactical strategies for selling the company’s solutions into each transplant center, it has created a regional structure. Each region consists of multiple territory account managers responsible for specific transplant centers.
Each region is also supported by the dedicated expertise of individuals that specialize in the company’s digital products, lab products, and clinical experts in medical science liaisons.
This model establishes accountability at the transplant center and regional level for the total revenue generated from the company’s transplant solutions. The territory account manager serves as the primary point of contact for each transplant center and has a deep understanding of the center’s transplant program objectives. By deeply understanding each center’s objectives, the company is able to deploy the right resources and solutions to support its customers.
Outside of the U.S., the company similarly has a regional structure that includes country managers in Western Europe, and distributors it works with outside of Western Europe to service the needs of the company’s transplant center customers globally.
Competition
In certain HLA tissue typing markets that incorporate a wide variety of technology test platforms, such as SSP, SSO, and NGS, competitors include: Thermo Fisher, Omixon, GenDx, BAG, Qiagen, and Immucor.
The company’s primary competitor for its patient management EMR solution is Phoenix, Epic's transplant application. The company’s referral application has two known competitors in T-REX and MedSleuth.
QTYPE competes with other quantitative polymerase chain reaction, or PCR, products, including products offered by Thermo Fisher, as well as alternatives to PCR, such as next generation sequencing, or NGS, typing products.
Intellectual Property
Patents and Proprietary Technology
As of December 31, 2024, the company had seven U.S. patents related to diagnosing transplant rejection and autoimmune disease, which will expire between October 2025 and May 2035. In addition, the company had three U.S. patents related to organ function recovery and allograft preservation, which will expire between July 2038 and June 2041.
The company has developed trade secrets and know-how since its inception. These trade secrets and know-how are found particularly in technical areas, such as optimized systems for making precise and reproducible q-PCR measurements, and in the analysis of genomic data and algorithm development.
AlloMap, AlloSure, AlloSeq, AlloCell, AlloHeme, QTYPE, Ottr, and CareDx are registered trademarks of the company in the United States.
License Agreements
Of the seven existing U.S. patents related to transplant rejection and autoimmunity, four are exclusively licensed.
In May 2018, the company entered into a license and commercialization agreement with Illumina, which provides it with worldwide distribution, development, and commercialization rights to Illumina’s next generation sequencing product line for use in transplantation diagnostic testing. Six issued U.S. patents for HLA genotyping are licensed as part of this agreement.
In April 2020, the company entered into a license agreement with Cornell University, pursuant to which it was granted exclusive rights to four U.S. patents covering methods and technology for the measurement of gene expression in urine to diagnose kidney transplant rejection.
In June 2021, the company entered into a strategic agreement, which was amended in April 2022, with OrganX to develop clinical decision support tools across the transplant patient journey. Together, the company and OrganX are developing advanced analytics that integrate AlloSure testing with large transplant databases to provide clinical data solutions. This partnership delivers the next level of innovation by incorporating a variety of clinical inputs to create a universal composite scoring system.
In March 2023, the company entered into a license and collaboration agreement with a private entity, pursuant to which it was granted an irrevocable, non-transferable right to commercialize its proprietary software, iBox, for the predictive analysis of post-transplantation kidney allograft loss in the field of transplantation for a period of four years, with exclusive rights in the United States.
Regulation
The company’s business is subject to, and impacted by, frequently changing laws and regulations in the United States and internationally. These laws and regulations include regulations particular to its business, and laws and regulations relating to conducting business generally (e.g., the U.S. Foreign Corrupt Practices Act, Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, and similar laws of other jurisdictions).
Under the CLIA, administered by the Centers for Medical and Medicaid Services (CMS), the company is required to hold a certificate applicable to the type of work it performs and to comply with standards covering personnel, facilities administration, quality systems, proficiency testing, and performance. The company has a certificate of accreditation under the CLIA to perform ‘high complexity’ testing. Laboratories performing high complexity testing are required to meet more stringent personnel and quality system requirements than laboratories performing less complex tests. To renew the company’s CLIA certificate, it is subject to inspection every two years to assess compliance with program standards. The company was inspected as part of the customary College of American Pathologists audit and recertified in 2024 as a result of passing that inspection. It expects the next regular inspection under the CLIA to occur in 2026.
In addition to federal certification requirements of laboratories under the CLIA, licensure is required and maintained for the company’s laboratory under California law. The company is required to maintain compliance with California standards as a condition to continue operation of its laboratory in California.
The FDA regulates the design, testing, development, manufacture, safety, labeling, marketing, promotion, storage, sale, and distribution of medical devices pursuant to its authority under the Federal Food, Drug and Cosmetic Act, or FFDCA. These regulations apply to all of the company’s products sold in the United States, as well as its facilities in Stockholm, Sweden, used to produce some of its products. The FDA has also asserted that it has the authority to regulate laboratory-developed tests, or LDTs, as medical devices under the FFDCA. An LDT is a test developed by a single laboratory for use only in that laboratory, such as its testing services, AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, and AlloSure Lung.
The FDA has traditionally chosen not to exercise its authority to regulate LDTs because it regulates the primary components in most laboratory-developed tests, and because laboratories, such as the company, certified as high complexity under the CLIA are regulated and reviewed by CMS to ensure that lab expertise and test procedures, and correct analyses are followed.
Under the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, the U.S. Department of Health and Human Services, or HHS, has issued regulations to protect the privacy and security of protected health information, and standardize data content, codes, and formats used in healthcare transactions, and the standardized identifiers used by healthcare providers, such as the company, and health plans.
The company is subject to the federal self-referral prohibitions, commonly known as the Stark Law, and to similar state restrictions, such as California’s Physician Ownership and Referral Act, or PORA.
The U.S. state privacy laws, such as the California Consumer Privacy Act, or the CCPA, which took effect in January 2020, and was amended by the California Privacy Rights Act, or the CPRA, effective January 2023, secure new privacy rights for consumers and impose new obligations on the company.
The company produces products which are CE labeled and subject to the In Vitro Diagnostic Medical Devices Directive (98/79/EC), or IVDD, a European Union, or EU, directive.
The company is also actively working with its notified body to bring the quality management system at the sites to be compliant with IVDR requirements by May 2025.
Certain of the company’s products also comply with the CMDCAS, which is a system designed to implement Canadian regulations requiring some medical devices to be designed and manufactured under a registered QMS. The SCC and Health Canada's Therapeutic Products Directorate developed this system. CMDCAS came into effect January 1, 2003.
History
The company was incorporated in Delaware in 1998 under the name Hippocratic Engineering, Inc. and in 1999 changed its name to BioCardia, Inc. and again changed its name to Expression Diagnostics, Inc. in 2002. Further, the company changed its name to XDx, Inc. in 2007 and to CareDx, Inc in 2014.
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