Thermo Fisher Scientific has introduced a new laboratory-developed test for post-transplant biopsy assessment designed to improve the detection of lung transplant rejection and injury, delivering quantifiable results that may increase diagnostic confidence and guide timely treatment.

Due to the significant risk of rejection, lung transplant recipients often require routine biopsies to monitor the health of their new lungs. Yet, when assessing the same lung biopsy sample, research shows that only 18 percent of pathologists will agree on a diagnosis of acute rejection.

Thermo Fisher’s new Molecular Microscope Diagnostic System for Lung (MMDx Lung) leverages the power of Machine Learning (ML) to profile gene expression data from lung biopsies, comparing each new sample to a reference set of over 896 lung biopsies. The system assesses the probability of rejection and provides molecular scores associated with injury, graft dysfunction and rejection. The results may aid in a pathologist’s assessment, with the aim of enabling greater confidence in the diagnosis and treatment of a lung transplant recipient.

“The diagnosis of rejection and injury in lung transplants is very challenging. 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 towards improving survival of lung transplants,” said Phil Halloran, Director, Alberta Transplant Applied Genomics Center and CEO, Transcriptome Sciences Inc.

Lung transplantation, once considered experimental, has evolved to become a standard of care for patients with end-state lung disease. In the past decade, the number of annual lung transplants in the US has nearly doubled. Despite medical advances, lung transplant recipients continue to face higher rates of rejection compared to other solid organ transplants, with a five-year survival rate of just under 60 percent.

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

In the United States, MMDx Lung is delivered through a collaboration with Kashi Clinical Laboratories, a market leader in transplantation immunodiagnostic lab testing.

“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. 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,” said Dr Todd Johnson, CEO, Kashi Clinical Laboratories.