CareDx Reports Over 200,000 Heart Transplant Patient Results Served

Rhea-AI Summary

CareDx, Inc. (Nasdaq: CDNA) has successfully delivered over 200,000 AlloMap® and AlloSure® test results to more than 30,000 heart transplant patients, showcasing its significant role in the U.S. heart transplant community. The company has been a trusted partner since 2005, with AlloMap being the only FDA-cleared gene-expression profiling test for heart transplants. CareDx’s HeartCare platform, which integrates both AlloMap and AlloSure, is now utilized by over 90% of heart transplant centers in the U.S., reflecting a strong attachment rate of clinical adoption.

Positive

• Over 200,000 AlloMap and AlloSure test results delivered to heart transplant patients.
• AlloMap is the only FDA-cleared gene-expression profiling test for heart transplants.
• CareDx services are used in more than 90% of U.S. heart transplant centers.

Negative

• None.

CareDx Testing Services Have Been Used in Over 30,000 Heart Transplant Patients and Over 90 Percent of Centers in the United States

SOUTH SAN FRANCISCO, Calif., April 14, 2022 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that it has delivered over 200,000 AlloMap® or AlloSure® results for over 30,000 heart transplant recipients.¹

“We are proud to have a long-standing and trusted relationship with the heart transplant community. Since 2005, we have served half of all heart transplant patients in the U.S. with AlloMap or AlloSure, and AlloMap has the distinction of being the only FDA cleared gene-expression profiling test (GEP) for use in heart transplants, the only GEP incorporated in International Society for Heart and Lung Transplantation guidelines, and the only one covered by CMS for multimodality assessment using AlloSure donor-derived cell-free DNA,” said Reg Seeto, CEO and President of CareDx. “Importantly, we have earned this trust by conducting multi-center prospective studies that have been published in leading journals such as the New England Journal of Medicine.”

“It’s 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 subsequently AlloSure Heart in 2020,” said Jeffrey Teuteberg, MD, Cardiologist, and Associate Professor of Cardiovascular Medicine, Stanford Health Care. “The evidence for using CareDx’s non-invasive testing for the surveillance of the transplanted heart has been demonstrated in numerous clinical studies,^2-7and therefore it comes as no surprise that this significant patient milestone 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 non-invasively monitor organ health in heart transplant recipients. AlloMap Heart subsequently received FDA clearance in 2008⁸ and is now used in more than 90 percent of heart transplant centers in the U.S.¹ In 2020, CareDx launched HeartCare which includes AlloMap gene-expression profiling and AlloSure donor-derived cell-free DNA (dd-cfDNA). Together, these biomarkers offer a multimodality view of transplanted organ health by providing two separate 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 percent, reflecting the clinical utility of multimodality surveillance.

About CareDx – The Transplant Company
CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along 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.

Forward Looking Statements
This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with AlloMap, AlloSure, and CareDx’s processing of heart transplant tests on patients. These forward-looking statements are based upon information that is 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 risks that CareDx does not realize the expected benefits of AlloMap, AlloSure, or CareDx’s processing of heart transplant tests 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 other reports that CareDx has filed with the SEC. Any of these may 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 undertaking to update or revise any such forward-looking statements.

CONTACTS:
CareDx, Inc.
Sasha King
Chief Marketing Officer
415-287-2393
sking@caredx.com

Investor Relations
Ian Cooney
(415) 722-4563
investor@CareDx.com 

References:

1. CareDx data of on file. March 7, 2022.
2. Holzhauser L, Clerkin KJ, Fujino T, et al. Donor-derived cell-free DNA is associated with cardiac allograft vasculopathy. Clin Transplant. 2021 Mar;35(3): e14206. doi: 10.1111/ctr.14206. Epub 2021 Feb 6. PMID: 33368611.
3. Khush KK, Patel J, Pinney S, et al. Noninvasive detection of graft injury after heart transplant using donor-derived cell-free DNA: A prospective multicenter study. Am J Transplant. 2019 Oct;19(10):2889-2899. doi: 10.1111/ajt.15339. Epub 2019 Apr 8. PMID: 30835940; PMCID: PMC6790566.
4. 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. Epub 2019 May 24. PMID: 31201087.
5. Crespo-Leiro MG, Stypmann J, Schulz U, et al. Clinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II. Eur Heart J. 2016 Sep 1;37(33):2591-601. doi: 10.1093/eurheartj/ehv682. Epub 2016 Jan 7. PMID: 26746629; PMCID: PMC5015661.
6. Kobashigawa J, Patel J, Azarbal B, et al. Randomized pilot trial of gene expression profiling versus heart biopsy in the first year after heart transplant: early invasive monitoring attenuation through gene expression trial. Circ Heart Fail. 2015 May;8(3):557-64. doi: 10.1161/CIRCHEARTFAILURE.114.001658. Epub 2015 Feb 19. PMID: 25697852.
7. Pham MX, Teuteberg JJ, Kfoury AG, et al. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med 2010; 362:1890-1900. DOI: 10.1056/NEJMoa0912965
8. AlloMap gene-expression profiling received Food and Drug Administration (FDA) clearance for heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment.

FAQ

What is the significance of CareDx's AlloMap test for heart transplant patients?

AlloMap is the only FDA-cleared gene-expression profiling test for heart transplants, providing non-invasive monitoring for organ health.

How many heart transplant patients have used CareDx testing services?

CareDx has delivered over 200,000 test results for more than 30,000 heart transplant recipients.

What percentage of U.S. heart transplant centers use CareDx's services?

CareDx's services are utilized by over 90% of heart transplant centers in the United States.

When did CareDx introduce its AlloMap test?

CareDx launched the AlloMap test in 2005, making it one of the first non-invasive monitoring tests for heart transplant patients.