On October 10, 2025, Thermo Fisher Scientific announced the launch of its Molecular Microscope® Diagnostic System for Lung (MMDx Lung), a laboratory‑developed test that applies machine‑learning algorithms to gene‑expression data from lung biopsy samples. The system compares each new sample to a reference set of more than 896 lung biopsies, calculates the probability of acute rejection, and generates molecular scores that indicate injury, graft dysfunction, and rejection risk.
The MMDx Lung platform is delivered through a partnership with Kashi Clinical Laboratories, a market leader in transplant immunodiagnostics. Kashi developed and validated the test, which is performed in its CLIA‑certified laboratory. The test is not yet FDA‑cleared or CE‑marked, but it is available for clinical use under the laboratory‑developed test (LDT) framework.
By providing quantitative, reproducible metrics in a field where pathologist agreement on rejection is only 18 %, the new diagnostic tool addresses a critical unmet need in lung‑transplant care. The launch expands Thermo Fisher’s portfolio in transplant diagnostics, offers a new revenue stream, and enhances the company’s position as a trusted partner for clinicians seeking precision in post‑transplant monitoring.
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