Tue. 12 Oct 2021, 10:21am ETBenzinga
In: News, FDA

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.