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About Omaroon

Building quantitative Phe monitoring for PKU.

People with PKU depend on blood phenylalanine results to manage a lifelong diet. We are developing a system designed to bring quantitative Phe measurement closer to the clinical decision.

Our mission

Better tools for monitoring phenylalanine in PKU.

Omaroon is developing an investigational quantitative phenylalanine monitoring system for PKU. The platform combines a single-use test, compact reader, and connected workflow.

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.

The system is not FDA cleared or approved and is not available for commercial clinical use. Omaroon Corporation was incorporated in 2021 and is based in Orange County, California.

Today and tomorrow

Clear about where we are.

Connected home monitoring is a planned future extension subject to additional development, validation, and applicable regulatory authorization.

  1. Step 1 · Current development

    Today

    Professional-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.

  2. Step 2 · Future direction

    Planned

    Connected home monitoring

    A planned future extension, subject to additional development, validation, and applicable regulatory authorization. It is not something the current system does.

Omaroon has engaged with FDA and continues regulatory development toward appropriate marketing authorization.

Funding support

Supported by NSF and NIH SBIR awards.

Omaroon's research is funded in part through the Small Business Innovation Research (SBIR) programs of the U.S. National Science Foundation and the National Institutes of Health.

  • NSF SBIR Phase I2021

    U.S. National Science Foundation

    Award 2051803

  • NSF SBIR Phase II2024

    U.S. National Science Foundation

    Award 2332518

  • NIH/NIGMS SBIR Phase I2026

    National Institute of General Medical Sciences, National Institutes of Health

    Award R43GM166946

Omaroon's work has been supported by the U.S. National Science Foundation and by the National Institute of General Medical Sciences of the National Institutes of Health. Content on this site is solely the responsibility of Omaroon and does not necessarily represent the official views of NSF or NIH. Federal funding does not imply endorsement.

We work with clinical and research collaborators. Ways to collaborate

Interested in working with Omaroon?

We welcome inquiries about clinical collaboration, research collaboration, product development and manufacturing, and investment.

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