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BOSTON, MA, September 4, 2025 – Ibex Medical Analytics (Ibex), a leader in artificial intelligence (AI)-powered cancer diagnostics, today announced it has received European In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for its HER2 breast cancer biomarker scoring solution.
Ibex’s fully automated “zero-click” AI-enhanced decision support tool for pathologists efficiently increases the accuracy and consistency of HER2 immunohistochemistry (IHC) scoring, including HER2-low cases. Ibex’s breast HER2 solution was developed and validated by Ibex in collaboration with AstraZeneca and Daiichi Sankyo.
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One of my most popular posts in 2022, with about a thousand views, asked if Low-Her2 analysis would be a "killer app" for digital pathology. Here; see 2023 follow up here. It sounds like the IBEX product will live up to that hope. (We don't know IBEX's FDA status for Her2 interpretation; IBEX has had breakthrough FDA status in the past, though.)
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The state of coding and pricing and coverage for digital pathology in the U.S. seems slower. Up until July 2024, the AMA CPT was creating digital pathology codes in the PLA code system, but that workstream seems to be frozen after July 2024. (AMA CPT will be discussing AI coding at its September 2025 meeting, including a new proposed category called CMAA or "Tab 94.")
By my tally, there have been 7 PLA codes in the WSI/digital interpretation field (0108U, 0261U, 0376U, 0414U, 0418U, 0512U, 0513U), most of which have been priced at $706.25. some of those codes include IHC slides, some are based on straight H&E WSI and digital algorithms.
However, as of 2024 data, utilization at Medicare has been limited. Of the seven codes, 0108U was paid $27M for 5,500 services, followed by 0261U being paid $615,000 for 870 services, followed by...well, nothing. As far as coverage rules, I couldn't find any yet for 0108U (e.g. an LCD or other article).
For codes and utlization data see cloud spreadsheet here.
