The machine learning-powered platform analyzes gene expression data from biopsies to provide molecular scores for rejection probability and tissue injury.
Thermo Fisher Scientific has launched the Molecular Microscope Diagnostic System for Lung (MMDx Lung), a laboratory-developed test designed to improve detection of lung transplant rejection and injury through molecular analysis of post-transplant biopsies.
The system uses machine learning to profile gene expression data from lung biopsies, comparing each sample to a reference set of more than 896 lung biopsies. The platform assesses rejection probability and provides molecular scores associated with injury, graft dysfunction and rejection to support pathologist assessment.
Current diagnostic challenges in lung transplant monitoring are significant. Research shows only 18% of pathologists agree on acute rejection diagnosis when assessing the same lung biopsy sample, according to the company.
“The diagnosis of rejection and injury in lung transplants is very challenging,” says Phil Halloran, director of Alberta Transplant Applied Genomics Center and CEO of Transcriptome Sciences Inc, in a release. “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-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.”
Addressing Clinical Need in Growing Market
Lung transplantation has evolved from an experimental procedure to standard care for patients with end-stage lung disease. Annual lung transplants in the US have nearly doubled over the past decade, yet recipients face higher rejection rates compared to other solid organ transplants, with five-year survival rates just under 60%.
Due to significant rejection risk, lung transplant recipients require routine biopsies to monitor transplanted organ health. The new diagnostic system aims to provide quantifiable results that may increase diagnostic confidence and guide timely treatment decisions.
“The launch of MMDx Lung enhances our 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,” says Tina Liedtky, president of transplant diagnostics at Thermo Fisher Scientific, in a release.
Laboratory Partnership and Availability
In the US, MMDx Lung is delivered through collaboration with Kashi Clinical Laboratories, which specializes in transplantation immunodiagnostic testing. The partnership expands the companies’ existing collaboration beyond kidney and heart transplant 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,” says Dr Todd Johnson, CEO of Kashi Clinical Laboratories, in a release.
This laboratory-developed test is used for clinical purposes by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the FDA or CE-marked in the EU as an in vitro diagnostic test.
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