SOUTH SAN FRANCISCO, Calif., April 14, 2022 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ is focused on the discovery, development and commercialization of clinically differentiated healthcare solutions and great value for transplant patients and caregivers – announced today that it has provided over 200,000 AlloMap® or AlloSure® results for over 30,000 heart transplant recipients.1
“We are proud to have a long-standing relationship of trust with the heart transplant community. Since 2005, we have served half of all heart transplant patients in the United States with AlloMap or AlloSure, and AlloMap has the distinction of being the only gene expression profiling (GEP) test approved by the FDA for use in heart transplants, the only GEP incorporated into International Society for Heart and Lung Transplantation Guidelines, and the only one covered by CMS for multimodality assessment using donor-derived AlloSure cell-free DNA,” said Reg Seeto, CEO and President of CareDx. “Most importantly, we have earned this trust by conducting prospective multicenter studies that have been published in leading journals such as New England Journal of Medicine.”
“It is exciting to see the widespread clinical adoption of CareDx’s transplant monitoring services since the company’s introduction of its first-of-its-kind product, AlloMap Heart, in 2005, and then AlloSure Heart in 2020,” said Jeffrey Teuteberg, MD, cardiologist, and associate professor of cardiovascular medicine, Stanford Health Care. “Evidence for the use of CareDx’s non-invasive tests for monitoring the transplanted heart has been demonstrated in numerous clinical studies,2-7and it is therefore not surprising that this important step for patients has been achieved.
In 2005, CareDx launched its first commercial product, AlloMap Heart, representing one of the first tests of its kind, a blood test to noninvasively monitor organ health in heart transplant recipients. AlloMap Heart then received FDA clearance in 20088 and is now used in over 90% of heart transplant centers in the United States1 In 2020, CareDx launched HeartCare which includes AlloMap gene expression profiling and AlloSure donor-derived cell-free DNA (dd-cfDNA). Together, these biomarkers provide a multimodal view of transplanted organ health by providing two distinct indicators of immune system activity and allograft health. CareDx’s HeartCare offering, which includes AlloMap Heart and AlloSure Heart, has an attachment rate of over 90%, reflecting the clinical utility of multimodal monitoring.
About CareDx – The Transplant Society
CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of healthcare solutions from high clinically differentiated value for transplant patients and caregivers. CareDx offers testing services, products and digital healthcare solutions throughout the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.
This press release contains forward-looking statements relating to CareDx, Inc., including statements regarding the benefits and potential results that may be achieved with AlloMap, AlloSure, and CareDx’s treatment of heart transplant testing patients. These forward-looking statements are based on information currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. , including the risks that CareDx does not realize the expected benefits of treatment with AlloMap, AlloSure or CareDx from heart transplant testing on patients; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed by CareDx with the SEC on February 24, 2022, and d other reports that CareDx has filed with SEC. Each of these items could cause CareDx’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertakes to update or revise these forward-looking statements.
- Record CareDx data. March 7, 2022.
- Holzhauser L, Clerkin KJ, Fujino T, et al. Donor-derived cell-free DNA is associated with cardiac allograft vasculopathy. Clin Graft. 2021 Mar;35(3):e14206. doi: 10.1111/ctr.14206. Published online February 6, 2021. PMID: 33368611.
- Khush KK, Patel J, Pinney S, et al. Noninvasive detection of graft damage after heart transplantation using donor-derived cell-free DNA: a prospective multicenter study. Am J Registry. 2019 Oct;19(10):2889-2899. doi: 10.1111/ajt.15339. Published online April 8, 2019. PMID: 30835940; PMCID: PMC6790566.
- Moayedi Y, Fan CS, Miller RJH, et al. Gene expression profiling and racial disparities in outcomes after heart transplantation. J Heart-lung transplant. 2019 Aug;38(8):820-829. doi:10.1016/j.healun.2019.05.008. Published online May 24, 2019. PMID: 31201087.
- Crespo-Leiro MG, Stypmann J, Schulz U, et al. Clinical utility of gene expression profiling to exclude acute rejection after heart transplantation: CARGO II. Eur Heart J. 2016 Sep 1;37(33):2591-601. doi: 10.1093/eurheartj/ehv682. Published online January 7, 2016. PMID: 26746629; PMC ID: PMC5015661.
- Kobashigawa J, Patel J, Azarbal B, et al. Randomized pilot trial of gene expression profiling versus cardiac biopsy in the first year after heart transplantation: early mitigation of invasive surveillance by gene expression assay. Cardiac failure Circ. 2015 May;8(3):557-64. doi: 10.1161/CIRCHEARTFAILURE.114.001658. Published online February 19, 2015. PMID: 25697852.
- Pham MX, Teuteberg JJ, Kfoury AG, et al. Gene expression profiling for monitoring rejection after heart transplantation. N English J med 2010; 362:1890-1900. DOI: 10.1056/NEJMoa0912965
- AlloMap gene expression profiling has received Food and Drug Administration (FDA) clearance for heart transplant recipients with stable allograft function who have a low likelihood of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment.