Thermo Fisher Launches New Diagnostic Test to Assess Lung Transplant Rejection Risk

Thermo Fisher Scientific has introduced a groundbreaking diagnostic tool aimed at improving the detection and management of lung transplant rejection. The new test, called the Molecular Microscope Diagnostic System for Lung (MMDx Lung), utilizes advanced machine learning techniques to analyze gene expression data from lung biopsies, providing physicians with crucial insights into the likelihood of transplant rejection.

Addressing a Critical Need in Transplant Medicine

Lung transplants have become increasingly common in the treatment of end-stage lung disease, with the number of procedures in the United States nearly doubling over the past decade. However, lung transplant patients continue to face higher rejection rates compared to other solid organ transplants, with a five-year survival rate below 60.2%.

The MMDx Lung test aims to address this challenge by offering a more sophisticated method of assessing rejection risk. By comparing biopsy samples to a reference set of over 896 lung biopsies, the system generates molecular scores related to injury and graft dysfunction, enabling more personalized patient care.

Technical Innovation in Transplant Diagnostics

Thermo Fisher's latest offering represents a significant advancement in the field of transplant diagnostics. The test employs machine learning algorithms to profile gene expression data, providing a level of detail and accuracy previously unavailable to transplant specialists.

Tina Liedtky, president of Thermo Fisher's transplant diagnostics group, emphasized the company's commitment to improving transplant outcomes: "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."

Regulatory Status and Future Implications

It's important to note that while the MMDx Lung test shows promise, it has not yet received clearance or approval from the FDA or EU regulatory agencies as an in vitro diagnostic application. The test was developed in collaboration with Kashi Clinical Laboratories, highlighting Thermo Fisher's strategy of partnering with specialized entities to advance its diagnostic capabilities.

This latest development follows Thermo Fisher's recent introduction of a multiplex protein panel for neurodegenerative disease research, demonstrating the company's broader focus on expanding its diagnostic portfolio across various medical fields. These advancements come in the wake of Thermo Fisher's $3.1 billion acquisition of Olink, a Swedish company specializing in protein-based analyzers, tests, and services, further solidifying its position in the molecular diagnostics market.