NIH Study Shows Using CareDx’s AlloSure Lung for Transplant Surveillance is More Effective than Diagnostic Bronchoscopy at Identifying Rejection

Rhea-AI Summary

CareDx, Inc. announced significant findings from the ALARM study published in The Journal of Heart and Lung Transplantation. The study validates the efficacy of AlloSure Lung for non-invasive monitoring of lung transplant recipients during the COVID-19 pandemic. Conducted across four centers, it showed that AlloSure can detect acute rejection and infection with a sensitivity of 73.9% and specificity of 87.7%. Notably, using this method reduced invasive biopsies by 83%. These advancements highlight a safer and effective approach for transplant patient surveillance.

Positive

• AlloSure Lung effectively detects acute rejection and infection in lung transplant recipients.
• The study demonstrated a sensitivity of 73.9% and specificity of 87.7%.
• Reduced the need for invasive biopsies by 83%, enhancing patient safety.

Negative

• None.

ALARM Study Publication Shows Use of AlloSure for Home-Based, Non-invasive Surveillance Monitoring Can Provide a Safer Option for Lung Transplant Recipients Navigating the COVID-19 Pandemic

SOUTH SAN FRANCISCO, Calif., Jan. 07, 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 the results of a study led by the National Institutes of Health (NIH), published in The Journal of Heart and Lung Transplantation¹, “Donor-derived Cell-free DNA as a Composite Marker of Acute Lung Allograft Dysfunction in Clinical Care,” that validates the ability of AlloSure® Lung to detect signs of organ rejection and infection in asymptomatic lung transplant recipients in a real-world, home-based surveillance setting. The use of AlloSure Lung also identified episodes of acute rejection and infection that would have been missed using a biopsy strategy alone.

ALARM (Lung Allograft Remote Monitoring) was a real-world, multicenter, prospective study conducted from March 24 to September 1, 2020, at the height of the pandemic. Four lung transplant centers used AlloSure Lung donor-derived cell-free DNA (dd-cfDNA) instead of surveillance bronchoscopy for transplant rejection surveillance in a home-based setting using CareDx RemoTraC™, an at-home blood draw phlebotomy service.

The study showed that non-invasive AlloSure Lung effectively identified acute cellular rejection (ACR), antibody-mediated rejection (AMR), and infection in asymptomatic lung transplant patients during routine surveillance screening. For diagnosis of ACR, AMR, or infection in these patients, dd-cfDNA yielded a sensitivity of 73.9%, specificity of 87.7%, positive predictive value of 43.4%, and negative predictive value of 96.5%, with an area under the curve (AUC) of 0.82 using the ALARM investigator’s protocol. Using an AlloSure Lung surveillance strategy, there were 83% fewer invasive biopsies than would have been performed under a surveillance biopsy program.

“Few patients are more vulnerable during the pandemic than lung transplant recipients who are not only on immunosuppressive medications, but having a higher infection risk than any other organ transplant population,” said Reg Seeto, CEO and President of CareDx. “The NIH study findings were achieved in real-world, home-based settings using our RemoTraC mobile phlebotomy service. This is a big step forward for non-invasive surveillance of lung transplant recipients.”

“As investigators on the ALARM study, which was a real-world, multicenter prospective study, we saw first-hand how AlloSure Lung can effectively monitor lung transplant patients for signs of rejection from the safety of their homes, which is especially important as these patients are much more susceptible to serious complications if infected with COVID-19,” said Dr. Shambhu Aryal, MD, FCCP, Medical Director, Lung Transplant Program and Director, Inova Sarcoidosis Center, Inova Medical Group. “Additionally, the use of a non-invasive blood test helps physicians reduce the number of surveillance bronchoscopies. This is important for lung transplant patients because around 5% of lung biopsies result in pneumothorax, or a collapsed lung, with more than half of them requiring chest tube drainage, which is a serious complication that can result in extended hospitalization and an increased risk of infections.”

AlloSure Lung’s ability to offer early warnings to physicians of possible infection or organ rejection can help inform timely therapeutic interventions. Lung transplant patients have one of the lowest median survivals of any solid organ transplant recipient, with a five-year survival rate of approximately 53%.² Introduced in October 2021, AlloSure Lung has already been adopted in over 20 lung transplant centers.³

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 through the ALARM study and AlloSure Lung. 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 the CareDx does not realize the expected benefits of the ALARM study or AlloSure Lung; risks that the results of the ALARM study may not be accurate; 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, 2020 filed by CareDx with the SEC on February 24, 2021, the quarterly report on Form 10-Q for the first quarter of 2021 ended on March 31, 2021 filed by CareDx with the SEC on May 5, 2021, the quarterly report on Form 10-Q for the second quarter of 2021 ended on June 30, 2021 filed by CareDx with the SEC on July 29, 2021, the quarterly report on Form 10-Q for the third quarter of 2021 ended on September 30, 2021, filed by CareDx with the SEC on October 28, 2021, 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. Keller M, Sun J, Mutebi C, et al. Donor-derived Cell-free DNA as a Composite Marker of Acute Lung Allograft Dysfunction in Clinical Care. The Journal of Heart and Lung Transplantation. December 26, 2021. DOI: https://www.jhltonline.org/article/S1053-2498(21)02630-9/fulltext
2. Organ Procurement and Transplantation Network National Data. https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/ Accessed online December 31, 2021.
3. CareDx data on file. December 31, 2021.

FAQ

What did the ALARM study reveal about AlloSure Lung?

The ALARM study demonstrated that AlloSure Lung can effectively monitor lung transplant recipients for signs of rejection and infection, reducing the need for invasive procedures.

What is the sensitivity and specificity of AlloSure Lung according to the ALARM study?

The study reported a sensitivity of 73.9% and a specificity of 87.7% for AlloSure Lung in detecting acute rejection and infection.

How much did AlloSure Lung reduce invasive biopsies?

Using AlloSure Lung reduced invasive biopsies by 83% compared to traditional biopsy methods.

When was the ALARM study conducted?

The ALARM study was conducted from March 24 to September 1, 2020.

Which journal published the findings of the ALARM study?

The findings were published in The Journal of Heart and Lung Transplantation.