01 Shift from General Diagnostics to Therapy-Linked Companion Diagnostics A major trend in the fluorescent in situ hybridization probe market is the shift from using FISH probes mainly for general cancer diagnostics to employing them as companion diagnostics directly tied to specific therapies. As per the U.S. FDA, the FDA had approved a PMA supplement for the Vysis ALK Break Apart FISH Probe Kit to include an indication for ENSACOVE (ensartinib) in non-small cell lung cancer (NSCLC), linking FISH testing directly to treatment decision making. This development highlighted the move from broad diagnostic use towards therapy-linked precision testing, which not only improved clinical adoption of FISH probes but also strengthened their role in guiding targeted cancer treatments.
02 Shift from High Regulatory Barriers to Streamlined Approvals A key trend in the global market is the shift from highly restrictive regulatory requirements to a more streamlined approval pathway. For example, in June 2025, the U.S. FDA reclassified FISH-based devices for detecting chromosomal abnormalities from the more restrictive Class III to Class II (special controls), which simplified regulatory requirements and facilitated faster clinical adoption. This change reflected the move from lengthy, complex approval processes to a more efficient regulatory pathway, which reduced barriers for manufacturers, accelerated product approvals, and supported faster market availability of advanced FISH probe products.
March 2026 Abbott expanded its molecular diagnostics portfolio with advanced FISH probe technologies designed to support genetic testing, cancer diagnostics, and precision medicine applications.
September 2025 Thermo Fisher Scientific introduced enhanced fluorescence-based molecular detection solutions to improve genomic analysis, cytogenetics, and research workflows.
May 2025 Agilent Technologies expanded its cytogenetics and molecular pathology solutions portfolio with advanced FISH probe technologies for clinical diagnostics and research applications.