Companies
Ventana Medical Systems
its VENTANA MMR RxDx panel companion diagnostic recently received EU IVDR approval across multiple cancer types and therapies, extending its global tissue-diagnostics platform.
- Country
- United States
Commercial
VENTANA MMR RxDx panel (Roche)
Coverage
| CN | EU | IN | US | |
|---|---|---|---|---|
| diagnostics-medtech | ✓ | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Capacity | Two automated dispenser filling lines each capable of filling 4 million dispensers annually, with space for a third line | biztucson.com |
| Certification | EU In Vitro Diagnostic Regulation (IVDR) certification for the VENTANA MMR RxDx Panel | diagnostics.roche.com |
| Regulatory approval | EU IVDR approval and US FDA approval for the VENTANA MMR RxDx Panel as a companion diagnostic across multiple cancer types and therapies | diagnostics.roche.com · accessdata.fda.gov · targetedonc.com |
| Production site | Manufacturing facilities in Oro Valley and Marana, Arizona | biztucson.com |
| Revenue | Exceeded $1 billion in total annual revenue as of 2019; recorded $238 million in 2006 and $376 million (Swiss francs) in 2008 post-acquisition | saddlebagnotes.com · sec.gov |
Independent sources: accessdata.fda.gov · biztucson.com · diagnostics.roche.com · saddlebagnotes.com · sec.gov · targetedonc.com
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Companion diagnostics platforms | diagnostics-medtech | Low | → |
Compiled by BIOECON from primary sources.
Compliance
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