Molecular Microscope Diagnostic System Assesses Lung Transplant Rejection

Lung transplant recipients face a significant risk of rejection and often require routine biopsies to monitor graft health, yet assessing the same biopsy sample can be highly inconsistent among pathologists. Lung transplants continue to have higher rejection rates than other solid organ transplants, with a five-year survival rate just under 60%. Now, a new laboratory-developed gene-expression profiling test can improve the detection of lung transplant rejection and injury.

Thermo Fisher Scientific (West Hills, CA, USA) is introducing the Molecular Microscope Diagnostic System for Lung (MMDx Lung), delivered in partnership with Kashi Clinical Laboratories (Portland, OR, USA), to provide molecular assessment of transplant biopsies. The system utilizes machine-learning models to profile gene expression from lung biopsies. It compares each sample to a reference set of over 896 lung biopsies, generating probabilities and molecular scores for injury, graft dysfunction, and rejection. MMDx Lung is offered as a CLIA-run laboratory-developed test (LDT) and reports molecular scores that aim to augment pathologists’ assessments and guide diagnostic workups.

Image: When assessing the same lung biopsy sample, research shows that only 18% of pathologists will agree on a TCMR diagnosis (Photo courtesy of Thermo Fisher)

The launch builds on prior work (including INTERLUNG-related technology) and validation performed by Kashi Clinical Laboratories, which developed and validated this LDT for clinical use. According to Thermo Fisher, the system may better diagnose rejection and detect chronic lung allograft dysfunction (CLAD)-related molecular changes, potentially providing a clearer guide for treatment and clinical trials. MMDx Lung is intended to deliver quantifiable, rapid results to increase diagnostic confidence in complex transplant cases.

By accelerating clinical decision-making through rapid, high-quality molecular results, the system is positioned to support treatment choices, identification of CLAD, and improved patient management. Thermo Fisher and its partners plan to integrate MMDx Lung into clinical workflows to help pathologists and transplant teams personalize care and potentially improve long-term 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,” said Tina Liedtky, president, Transplant Diagnostics, Thermo Fisher Scientific.”

Related Links:
Thermo Fisher Scientific
Kashi Clinical Laboratories