Thermo Fisher Showcases Diagnostics Suite at ADLM 2026

Thermo Fisher Scientific has unveiled an expanded end-to-end diagnostics portfolio at the Association for Diagnostics & Laboratory Medicine (ADLM) Conference in Anaheim, headlined by the recently FDA-cleared EXENT Solution for multiple myeloma monitoring and the June 2026 FDA 510(k) clearance of the EliA CTD 13 Screen for connective tissue disease testing. Announced on 27 July 2026, the showcase runs 26-30 July 2026 and spans oncology, autoimmune, maternal and molecular diagnostics.

The EXENT Solution is a fully integrated automated mass spectrometry platform for multiple myeloma diagnosis, addressing a pathway historically hampered by slow turnaround and subjective interpretation. Multiple myeloma affects more than 176,000 people worldwide each year, with EXENT now available for clinical use in the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Switzerland, Australia, New Zealand, Canada and Brazil. In oncology, the Oncomine Dx Express Test on the Ion Torrent Genexus Dx sequencer, FDA-approved as a companion diagnostic for sunvozertinib (Zegfrovy) in non-small cell lung cancer, delivers NGS results in as little as 24 hours, tying directly into AstraZeneca’s recent $1.5bn Zegfrovy licensing deal with Dizal.

The EliA CTD 13 Screen received FDA 510(k) clearance in June 2026 for use on the Phadia 250 instrument, covering systemic lupus erythematosus, Sjögren’s syndrome, systemic sclerosis, polymyositis, dermatomyositis and mixed connective tissue disease. Thermo Fisher’s B·R·A·H·M·S biomarker portfolio, anchored by KRYPTOR Analyzers, features the PreClara Ratio (the first FDA-cleared preeclampsia risk assessment biomarker) and procalcitonin testing for sepsis antibiotic stewardship. On the QC side, LabLink360 software combined with MAS Max quality controls links Sigma-metric analysis to routine workflow.

The commercial signal is Thermo Fisher tightening its end-to-end diagnostics footprint across specialty disease areas, from rare blood cancers through autoimmune, maternal health and transplant medicine. With Puneet Sarin’s specialty diagnostics group increasingly integrating instruments, assays and digital layers, expect continued competitive pressure on Roche Diagnostics, Danaher’s Beckman Coulter, Abbott, Siemens Healthineers and BioMérieux across the specialty diagnostics competitive set.

For the latest updates and in-depth insights into the world of Service Engineering, including breakthrough treatments, industry trends, and regulatory news, contact Adam Tiberius today!