CareDx, Inc., together with its subsidiaries, operates as a transplant diagnostics company with product offerings along the pre- and post-transplant continuum. The company focuses on discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients. In diagnostic testing services, the company offers AlloMap, which is a gene expression solution for heart transplant patients and AlloSure, which is a donor-derived cell-free DNA (dd-cfDNA) solution initially commercialized for kidney transplant patients. The company also offers products that increase the chance of transplants by facilitating a match between a donor and a recipient of stem cells and organs. Testing Services AlloMap The company’s first commercialized testing solution, the AlloMap heart transplant molecular test (AlloMap) is a gene expression test that helps clinicians monitor and identify heart transplant recipients with stable graft function who have a low probability of moderate-to-severe acute cellular rejection. The company focuses on expanding the adoption and utilization of its AlloMap solution through ongoing studies to substantiate the clinical utility and actionability of AlloMap, secure positive reimbursement decisions for AlloMap from large private and public payers, develop and improve its relationships with key members of the transplant community, including opinion leaders at major transplant centers, and explore opportunities and technologies for the development of additional solutions for post-transplant surveillance. AlloMap has received 510(k) clearance from the U.S. Food and Drug Administration for marketing and sale as a test to aid in the identification of recipients with a low probability of moderate or severe acute cellular rejection. AlloSure AlloSure, the company’s surveillance solution for kidney transplant recipients, applies proprietary next generation sequencing technology to measure dd-cfDNA in the blood stream emanating from the donor organ. Effective October 9, 2017, AlloSure became available for commercial testing with Medicare coverage and reimbursement. AlloSure has also received payment from private payers on a case-by-case basis, while the company’s Payer Relations team works to establish positive coverage. HeartCare In September, 2018, the company initiated the Surveillance HeartCare Outcomes Registry (SHORE). SHORE is a prospective, multi-center, observational, registry of patients receiving HeartCare for surveillance. HeartCare combines the gene expression profiling technology of AlloMap with the dd-cfDNA analysis of AlloSure-Heart in one surveillance solution. An approach to surveillance using HeartCare provides information from the two complementary measures, AlloMap, a measure of immune activation, and AlloSure-Heart, a measure of graft injury. HeartCare provides complementary information about distinct biological processes, such as immune quiescence, active injury, Acute Cellular Rejection and Antibody Mediated Rejection in heart transplant recipients. Products The company develops, manufactures, markets and sells products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. Olerup SSP is used to type Human Leukocyte Antigen, or HLA alleles based on sequence-specific primer technology. Olerup SBT is a product range for sequence-based typing of HLA alleles. QTYPE enables speed and precision in HLA typing at a low to intermediate resolution for samples that require a fast turn-around time and uses real-time polymerase chain reaction, methodology. QTYPE received CE mark certification in 2018. The company has a License Agreement with Illumina, Inc. (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. Sales and Marketing Testing Services Sales and Marketing Team: The company has a direct field team in the United States that interacts with all aspects of the testing services channel, includin
caredx inc (CDNA:NASDAQ GM)
3260 Bayshore Boulevard
Brisbane, CA 94005
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