Benzinga | Dec 16, 2021 07:03AM EST

CareDx Enrolls First Patient In LungCare Registry Study To Measure Impact Of Multimodality Assessment On Lung Transplant Patient Outcomes

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 enrollment of the first patient in the multicenter, observational, prospective ALAMO registry to improve lung transplant patient care.

The AlloSure Lung Assessment and Metagenomic Outcomes (ALAMO) registry will enroll 1,000 patients from lung transplant centers across the United States. The registry will follow patients using LungCare, which includes commercially available AlloSure(r) Lung, and research use of AlloMap(r) Lung, AlloID, and other complementary tests. AlloSure is a donor-derived cfDNA test which identifies organ injury, AlloMap is a gene expression test which identifies immune quiescence, and AlloID is a metagenomic infectious disease test which identifies more than 100 pathogens specific to organ transplant patients.

The ALAMO registry will examine CareDx's LungCare to inform biopsy and treatment decisions following lung transplantation. Its primary endpoints are three-year survival without chronic lung allograft dysfunction (CLAD) and three-year, severe infection-free survival.

"Multimodality diagnostics are transforming the transplantation landscape, giving physicians multiple measures of organ health to detect possible infection and organ rejection earlier than invasive biopsies alone," said Dr. Sham Dholakia, Chief Medical Officer at CareDx. "Lung transplant recipients have the highest unmet needs in all of transplantation, including the highest rates of one-year acute rejection and the lowest five-year survival rate at approximately 50%.1 LungCare will be the most comprehensive assessment of allograft health ever measured."

While transbronchial biopsies, the current standard of care, are a valuable tool for monitoring allograft health, they carry a 10.8% rate of moderate to severe complications including hemorrhaging and collapsed lung.2,3 Risks are even higher for complications due to the increased COVID transmission risk for these patients on immunosuppressive medications.

"The ALAMO study is going to be the first real-world data to show the potential of multimodality testing as a new standard of care to improve lung transplant clinical outcomes," said Ali Mansour, MD, Advanced Lung Failure and Lung Transplant at Montefiore Medical Center. "Given the ongoing COVID risk to lung transplant patients with suppressed immune systems, this non-invasive panel represents an important potential diagnostic breakthrough as we do everything in our power to help physicians avoid unnecessary biopsies."