The American Society of Transplant Surgeons Position Statement Supports Use of CareDx’s AlloSure Kidney for Organ Transplant Surveillance

Rhea-AI Summary

CareDx, Inc. (Nasdaq: CDNA) announced the American Society of Transplant Surgeons (ASTS) supports its AlloSure Kidney and AlloMap Heart testing for organ transplant surveillance. The ASTS position statement endorses the use of donor-derived cell-free DNA (dd-cfDNA) to monitor kidney transplant recipients, particularly to rule out subclinical antibody-mediated rejection (ABMR). It also recommends dd-cfDNA for heart transplants and peripheral blood gene expression profiling as a non-invasive diagnostic tool for heart transplant recipients over 55 days post-transplant. CEO Reg Seeto praised ASTS for this leadership.

Positive

• ASTS supports the use of dd-cfDNA in kidney transplant recipients, enhancing credibility for AlloSure Kidney.
• Endorsement of AlloSure Heart increases the potential for expanded market adoption.
• The position statement solidifies CareDx's role in non-invasive transplant monitoring.

Negative

• None.

Statement Also Supports Use of AlloSure Heart and AlloMap Heart  

BRISBANE, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced the issuance of a new position statement by the American Society of Transplant Surgeons (ASTS) supporting the use of CareDx’s AlloSure® Kidney for organ transplant surveillance, and AlloSure Heart and AlloMap® Heart.

Specifically, the new position statement, “ASTS Statement on donor-derived cell-free DNA (dd-cf-DNA)”:

• Supports consideration of donor-derived cell-free DNA (dd-cfDNA), as in AlloSure Kidney, for surveillance in kidney transplant recipients to exclude subclinical antibody mediated rejection (ABMR).
• Recommends dd-cfDNA (AlloSure Kidney) for use in kidney transplant recipients experiencing acute allograft dysfunction to exclude rejection, particularly ABMR.
• Recommends that dd-cfDNA (AlloSure Heart) may be utilized to rule out subclinical rejection in heart transplant recipients.
• Recommends peripheral blood gene expression profiling (GEP), as in AlloMap Heart, as a non-invasive diagnostic tool to rule out acute cellular rejection in stable, low-risk, adult heart transplant recipients who are over 55 days status post heart transplantation.

“We applaud ASTS for their leadership in issuing a position statement on the use of dd-cfDNA for routine monitoring of allograft health in kidney, and additionally the use of dd-cfDNA and peripheral blood gene expression profiling in heart,” said Reg Seeto, CEO and President of CareDx.

To read the position statement, go here.

About CareDx – The Transplant Company

CareDx, Inc., headquartered in Brisbane, 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 ASTS position statement and the potential benefits and results that may be achieved with CareDx’s non-invasive testing services, AlloSure and AlloMap. 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 its testing services; 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, 2022 filed by CareDx with the SEC on February 27, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230307005693/en/

CareDx, Inc.

Media Relations

Anna Czene

818-731-2203

aczene@caredx.com

Investor Relations

Greg Chodaczek

investor@caredx.com

Source: CareDx, Inc.

FAQ

What is the ASTS position statement regarding CareDx's AlloSure Kidney?

The ASTS position statement supports the use of AlloSure Kidney for surveillance in kidney transplant recipients to exclude subclinical antibody-mediated rejection (ABMR).

How does the ASTS statement impact AlloMap Heart?

The ASTS recommends using dd-cfDNA from AlloSure Heart to rule out subclinical rejection in heart transplant recipients.

When was the ASTS position statement announced?

The ASTS position statement was announced on the day of the press release by CareDx.

What does CareDx's CEO say about the ASTS's position statement?

CEO Reg Seeto applauded ASTS for their leadership in issuing the position statement on dd-cfDNA for allograft health monitoring.