Thermo Fisher Introduces MMDx Lung, An AI-Driven Molecular Test To Detect Lung Transplant Rejection

Thermo Fisher Scientific, the global leader in serving science, has unveiled a new laboratory-developed test (LDT) for post-transplant biopsy assessment, designed to enhance the detection of lung transplant rejection and injury. The Molecular Microscope® Diagnostic System for Lung (MMDx® Lung) delivers quantifiable molecular data that can improve diagnostic confidence and enable faster, more informed treatment decisions for clinicians.

“The diagnosis of rejection and injury in lung transplants is very challenging,” said Phil Halloran, Director, Alberta Transplant Applied Genomics Center and CEO, Transcriptome Sciences Inc. “Based on technology developed by the investigators in the INTERLUNG study, we believe MMDx Lung will better diagnose rejection and detect Chronic Lung Allograft Dysfunction (CLAD)-related molecular changes, and thus provide a better guide for treatment and potentially for clinical trials, as a step toward improving survival of lung transplants.”

Lung transplant recipients face a high risk of rejection, making routine biopsies essential for ongoing monitoring. However, diagnostic variability remains a major challenge — studies reveal that only 18% of pathologists reach the same conclusion when evaluating identical biopsy samples for acute rejection. MMDx Lung addresses this challenge by applying machine learning algorithms to analyze gene expression profiles from lung biopsies. Each sample is compared against a reference database of more than 896 lung biopsies, generating molecular scores that reflect rejection probability, graft injury, and dysfunction to support more consistent, objective interpretations.

“The launch of MMDx Lung enhances our comprehensive portfolio of post-transplant monitoring solutions and reflects our ongoing commitment to helping our customers personalize patient care and improve outcomes throughout the transplant journey,” said Tina Liedtky, president, Transplant Diagnostics, Thermo Fisher Scientific.

Lung transplantation has transitioned from a once-experimental procedure to a standard-of-care treatment for end-stage lung disease, with U.S. transplant volumes nearly doubling in the past decade. Yet, despite progress, lung recipients still experience higher rejection rates than other organ transplant patients, with a five-year survival rate below 60%. In the U.S., MMDx Lung is available through a collaboration with Kashi Clinical Laboratories, which developed and validated the LDT in its CLIA-certified facility. While not FDA-cleared or CE-marked, the test represents a significant step toward more precise molecular diagnostics in lung transplantation.

“Accelerating clinical decision-making through the delivery of high quality, rapid results, is central to our mission of advancing health and healing to every patient we serve,” said Dr. Todd Johnson, CEO, Kashi Clinical Laboratories. “We're proud to expand our collaboration with Thermo Fisher Transplant Diagnostics to deliver services for lung, in addition to kidney and heart transplant testing.”