Patient dashboard
See every reading against your target range, spot trends, and keep notes alongside your results.
PQS1.0In development · Supported by NSF SBIR Phase II
Revolutionizing PKU care, one drop at a time.
Our PQS1.0 monitor is being developed to deliver rapid Phe results from a fingerprick, at home or at the point of care, so families don't have to wait days for mail-in lab tests.
- NSF SBIR Phase I & II
- Clinical collaboration with CHOC
- Built with HIPAA safeguards
Concept illustration. Investigational device, not available for sale.
Why it matters
PKU is managed one blood test at a time.
Phenylketonuria (PKU) is an inherited condition in which the PAH enzyme does not work properly, so the body cannot break down the amino acid phenylalanine (Phe). Without treatment, Phe builds up in the blood and can harm the brain. People with PKU follow a lifelong low-Phe diet and need regular blood tests to stay in range.
20,000–35,000
Estimated number of people in the US living with PKU.
Source: NSF SBIR Phase II award abstract(opens in a new tab)
Lifelong
PKU is a lifelong genetic disorder that requires constant tuning of diet therapy, guided by blood Phe levels.
120–360µmol/L
Lifelong target range for blood Phe recommended by ACMG guidelines.
Source: ACMG guideline (Vockley et al., 2014)(opens in a new tab)
5–7days
Typical turnaround for laboratory blood Phe results, and sometimes longer.
How it works
Prick. Read. Share.
The PQS1.0 Rapid Phenylalanine Blood Level Monitor is designed to replace the mail-in wait with a few simple steps.
STEP 01
Prick
A single drop of blood from a fingerprick goes onto a disposable test strip, which chemically treats the sample.
STEP 02
Read
The handheld reader measures phenylalanine using spectroscopy, aiming for a workflow as familiar as a glucose meter.
STEP 03
Share
Readings are designed to sync to the Omaroon care platform, where patients and their care team can review trends together.
Describes the intended design of an investigational device in development. The PQS1.0 has not been cleared or approved by the FDA.
The care platform
One shared view of Phe, for patients and their care team.
Readings from the monitor (in development) are designed to sync into a secure dashboard that patients and clinicians share, with messaging and notifications built in.
Clinician dashboard
Assigned patients at a glance, with each patient's latest reading and full history.
Secure messaging
Message your care team in context, with read receipts and real-time delivery.
Real-time notifications
Stay in sync when there are new messages or care-team assignments.
HIPAA-ready safeguards
Role-based access, row-level data isolation, audit logging, and encryption in transit and at rest.
Already part of a care team on Omaroon?
Sign in to the platformMilestones
From research to readiness.
Key steps on the path from NSF-funded feasibility work toward a commercial-ready monitor.
2021
Omaroon Corporation incorporated
Founded to build rapid phenylalanine monitoring for people living with PKU. Based in Orange County, California.
2021
NSF SBIR Phase I award
National Science Foundation award #2051803 ($256,000), 2021–2022.
2021
Accelerator support from CTIP
The FDA-funded pediatric medical device accelerator based at Children's Hospital Los Angeles.
NSF
NSF I-Corps participant
Customer discovery through the NSF Innovation Corps program.
2022
Feasibility testing
Feasibility work on the test strip and spectroscopic reader under the Phase I award.
2023
Began FDA regulatory activities
Including a Pre-Submission meeting with the FDA Office of Orphan Products Development, toward a Humanitarian Use Device pathway.
2024
NSF SBIR Phase II award
Award #2332518 ($997,142), starting May 2024: enhancing performance and achieving commercial readiness for the PQS1.0.
2025
Care platform MVP (web dashboard)
Patient and clinician dashboards, secure messaging, and notifications.
Programs & funding support
Backed by programs that build medical devices.
Non-dilutive federal research funding, incubation, accelerator support, and clinical collaboration.
Accelerator
CTIP
FDA-funded pediatric device accelerator based at Children's Hospital Los Angeles
Founders
Built by a team focused on PKU.
Omaroon is led by its co-founders and works with the metabolic team at CHOC to keep development grounded in real clinical needs.
More about OmaroonHiba Fakhro
Co-founder & Chief Executive Officer
Leads Omaroon's strategy, partnerships, and path to market for the PQS1.0.
Louay Fakhro
Co-founder & Chief Technology Officer
Leads technology development and serves as Principal Investigator on Omaroon's NSF SBIR awards.
Get the app
Your care platform, one tap away.
Install Omaroon on your iPhone or Android phone straight from the browser. No app store needed.
- iPhone: Safari → Share → Add to Home Screen
- Android: Chrome → menu → Install app
Help shape the future of PKU monitoring
Clinicians, researchers, and families: join the early access list or partner with us on clinical collaboration and research.