# Biocartis

Source: https://onco.cc/companies/biocartis/  
OnCo record `biocartis` (Company). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Belgian maker of the Idylla molecular tests, one of which is the FDA companion diagnostic for nivolumab in MSI-high bowel cancer.

## Summary

Biocartis is a privately held molecular diagnostics company headquartered in Mechelen, Belgium, built around its Idylla platform. Its Idylla CDx MSI Test was approved by the FDA in August 2025 as the companion diagnostic for nivolumab, alone or with ipilimumab, in microsatellite instability-high colorectal cancer.

## Fields

- Kind: Company
- Last checked: 2026-11-03
- HQ: Mechelen
- Type: diagnostics
- Website: https://www.biocartis.com

## Sources

- Biocartis: about us: https://www.biocartis.com/en/about-us
- FDA PMA P250005: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250005

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- drugs: [Idylla CDx MSI Test](https://onco.cc/drugs/idylla-cdx-msi/)

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JSON: https://onco.cc/api/v1/entities/biocartis.json