AlloSure, the First dd-cfDNA in Heart and Kidney Transplantation, Launches for Lung Transplant Patients

Rhea-AI Summary

CareDx, Inc. (Nasdaq: CDNA) announced the commercial launch of AlloSure Lung on October 12, 2021, in conjunction with the CHEST 2021 Meeting. This non-invasive testing solution aims to improve the management of high-risk lung transplant patients, who face significant survival challenges and the risk of Chronic Lung Allograft Dysfunction (CLAD). AlloSure Lung has already received coverage from several private payers and is supported by three clinical validation studies involving 155 patients. The product aims to meet an unmet need and enhance precision care for transplant patients.

Positive

• Successful commercial launch of AlloSure Lung expands CareDx's precision medicine offerings.
• AlloSure Lung is already covered by multiple private payers.
• Supports high-risk lung transplant patients with a non-invasive testing solution.
• Three clinical validation studies demonstrate clinical benefits of AlloSure Lung.

Negative

• The commercialization of AlloSure in lung transplantation may not be widely successful as expected.
• Potential risks associated with the success of AlloSure in lung transplants not indicative of other organs.

AlloSure Significantly Improves Management of High-Risk Lung Transplant Patients

SOUTH SAN FRANCISCO, Calif., Oct. 12, 2021 (GLOBE NEWSWIRE) -- 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, announced today the commercial launch of AlloSure Lung to coincide with the CHEST 2021 Meeting starting on October 16.

AlloSure, which is commercially available and broadly used in kidney and heart transplantation, will now be widely available for use in lung transplantation. CareDx is working with payers to obtain coverage for AlloSure Lung across the payer landscape. AlloSure Lung is already covered by multiple private payers, and is meeting an incredible unmet need for lung transplant patients.

Lung transplantation has one of the lowest median survivals of any solid organ transplant, with a 5-year survival rate of 53%. Lung transplant patients have an increased incidence of Chronic Lung Allograft Dysfunction (CLAD), which is a form of chronic organ rejection. These patients are not only on more intensive immunosuppressive regimens to forestall rejection, but also have an increased frequency of infectious complications due to these higher immunosuppression levels and contact of the lung graft with the outside environment.

"Non-invasive precision medicine testing represents the next major advance in the care of lung transplant patients," said Dr. Sam Weigt, Transplant Pulmonologist and Director of the Lung Transplant Translational Research Program, UCLA. "AlloSure Lung is a great tool to help us manage this severely at-risk patient population."

"We are extremely proud at CareDx to launch the first clinically validated and non-invasive surveillance solution to assess lung transplant patients," said Reg Seeto, President and Chief Executive Officer, CareDx. "AlloSure Lung further solidifies our leadership in precision care for transplant patients as we expand to new organs."

With the COVID pandemic, the need for home-based, noninvasive tools to monitor lung transplant patients became more critical. CareDx made AlloSure Lung available to centers through the RemoTraC mobile phlebotomy service to support these high-risk patients. Three clinical validation studies have been published to show the clinical benefit of AlloSure Lung in managing patient care with data from 11 centers across 155 patients, where 61 experienced a rejection episode.

"The lung transplant community is excited about this advancement in diagnostics for our patients. As investigators on the ALARM study, alongside the NIH Graft consortium, our group has seen the valuable benefit that AlloSure Lung can bring to our field," said Deborah Levine, MD, UT Health San Antonio.

About CareDx
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 commercial launch of AlloSure Lung, and the potential benefits and results that may be achieved through 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 AlloSure Lung; risks that the commercialization of AlloSure in lung transplantation may not be as widely successful as expected; risks that the success of AlloSure in lung transplantation may not be indicative of its success in other organs; 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 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

FAQ

What is AlloSure Lung by CareDx?

AlloSure Lung is a non-invasive precision medicine testing solution for lung transplant patients aimed at improving patient management.

When was AlloSure Lung launched?

AlloSure Lung was commercially launched on October 12, 2021.

How does AlloSure Lung benefit lung transplant patients?

It helps manage high-risk lung transplant patients by monitoring for organ rejection non-invasively.

Is AlloSure Lung covered by insurance?

Yes, AlloSure Lung is already covered by multiple private payers.

What studies support the effectiveness of AlloSure Lung?

Three clinical validation studies involving 155 patients support the clinical benefits of AlloSure Lung.

What are the risks associated with AlloSure Lung's commercialization?

There are risks that the commercialization may not be as successful as expected or indicative of success in other organ transplants.