Lab Automation & Research Tools · Projected milestone
Organ-chip assay qualifies for drug decisions
85% by 2035 · including earlier years
The year is an editorial timing estimate. The percentage applies to occurrence by the stated deadline. These estimates are not calibrated odds.
A named regulator formally qualifies an organ-chip assay for a specified drug-development context of use.
Explore this milestone on the interactive mapWhat the forecast means
Milestone stage: regulatory qualification
organ-chip physical capability already demonstrated; qualification pending
Timing window: 2027–2033. An editorial range, not a statistical confidence interval.
Completion criteria: A named regulator formally qualifies an organ-chip assay for a specified drug-development context of use. Resolve only from inspectable evidence meeting every stated criterion; a plan or extrapolation does not resolve it.
This page describes a forecast, rather than an achieved result. Read the methodology and assumptions.
Built on
- Randomised controlled trialRecorded · 1948influences
- Organ on a chipRecorded · 2010requires
Led to
Sources & evidence
- FDA accepts first organ-chip letter of intent into ISTAND 2024-09
The September 2024 liver-chip LOI was the first stage of a three-stage qualification process, limited to a specific context of use.
- Emulate submits full FDA ISTAND qualification package 2026-09-09
Company reported full qualification-package submission on 9 September 2026; submission is not FDA qualification.
- FDA ISTAND program
Official process and current announcements; narrow contexts of use are qualified individually.
Astra editorial synthesis; cited researchers retain credit for their results
Record reviewed 2026-10-18