New fingerstick test could simplify PKU monitoring at home

NCT ID NCT05998109

Completed Diagnosis Sponsor: Lumos Diagnostics Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a new device called PheCheck that measures phenylalanine levels from a fingerstick blood sample, intended for home use by people with PKU. Researchers compared its accuracy to the standard lab test in 30 participants aged 10 and older. The goal was to see if the device is easy to use and gives reliable results.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: PheCheck™ rapid test device
What this could lead to: If successful, this could give people with PKU a convenient way to monitor their phenylalanine levels at home, reducing the need for frequent clinic visits.
What could go wrong: This is a small feasibility study with only 30 participants, so results may not apply to everyone. The test may not be as accurate as the lab method, and home use could introduce errors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

hyperphenylalaninemia due to tetrahydrobiopterin deficiency phenylketonuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PHENYLKETONURIAS

Contacts and locations

Locations

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

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