COMPONENT 01
Single-use test
Designed for quantitative Phe measurement.
Technology
An investigational quantitative Phe monitoring system.
Omaroon's platform combines a single-use test, compact reader, and connected workflow.
Investigational device. Not FDA cleared or approved. Not available for commercial clinical use.
The platform
Three components, designed to work together.
Each component is part of an investigational system in development. Designs may change.
Concept illustration only. Not a product design.
COMPONENT 02
Compact reader
Designed for near-patient quantitative analysis.
COMPONENT 03
Connected workflow
Designed to support longitudinal results and future clinician-connected monitoring.
Development status
Where development stands today.
Current development is focused on professional-use evaluation using prepared plasma. Omaroon has completed end-to-end testing in prepared human plasma, including a blinded evaluation in a hospital clinical laboratory.
Step 1 · Current development
TodayProfessional-use / prepared-plasma evaluation
Development is focused on professional-use evaluation using prepared plasma. The system is investigational and is not available for commercial clinical use.
Step 2 · Future direction
PlannedConnected home monitoring
A planned future extension, subject to additional development, validation, and applicable regulatory authorization. It is not something the current system does.
Regulatory status
Omaroon has engaged with FDA and continues regulatory development toward appropriate marketing authorization.
Investigational device. Not FDA cleared or approved. Not available for commercial clinical use.
Technical information
Detailed technical and performance information is not published on this website. Qualified clinical, research, and development collaborators are welcome to contact us.
Interested in working with Omaroon?
We welcome inquiries about clinical collaboration, research collaboration, product development and manufacturing, and investment.