New gene expression profiling test enhances precision in assessing lung transplant rejection and injury

Thermo Fisher Scientific, the world leader in serving science, 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% of pathologists will agree on a diagnosis of acute rejection.¹

Thermo Fisher’s new Molecular Microscope® Diagnostic System for Lung (MMDx® Lung) leverages the power of machine learning 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,” 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 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 U.S. 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%.²

“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.

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,” 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.”

To learn more about the MMDx portfolio, visit thermofisher.com/mmdx

MMDx and Molecular Microscope are registered trademarks of Transcriptome Sciences Inc.

MMDx Lung was developed and validated by Kashi Clinical Laboratories, LLC. This laboratory developed test (LDT) is used for clinical purposes by the CLIA-certified laboratory performing the test. This test has not been cleared or approved by the US FDA or CE marked in the EU as an in vitro diagnostic test.

¹Arcasoy, S M, et al. “Pathologic interpretation of transbronchial biopsy for acute reject of lung allograft is highly variable,” Am J Transplant. 2011 Feb;11(2):320-8. doi: 10.1111/j.1600-6143.2010.03382.x. Epub 2011 Jan 10. PMID: 21219569

²Valapour, Maryam, et al. “OPTN/SRTR 2023 Annual Data Report: Lung,” Scientific Registry of Transplant Recipients, Health Resources & Services Administration. February 2025. https://srtr.transplant.hrsa.gov/ADR/Chapter?name=Lung&year=2023. Accessed September 8, 2025.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

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