PheCheck™ Validation Study

Starting soon

Conditions studied: Phenylketonuria (PKU) and Hyperphenylalaninemia

In brief

The goal of this observational study is to evaluate the performance of the PheCheck™ test for the rapid detection of phenylalanine (Phe) from a fingerstick sample, in patients 1 year or older with phenylketonuria (PKU) or hyperphenylalaninemia. The main objective is comparing the concentration of phenylalanine (Phe) in capillary blood with the reference method (DBS).

Key facts

Study ID

NCT07551921

Run by

Aptatek BioSciences, Inc

People needed

60

Starts

2026-05-20

Expected to finish

2027-03-15

Last updated by the study team

2026-04-27

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1 year or older and able to have a fingerstick blood collected
• Being monitored for Phenylketonuria (classical PKU, mild PKU, variant PKU, or hyperphenylalaninemia)
• Signed informed consent

You may not qualify if…

• Previous enrollment in the study and has completed 3 study visits
• Inability to read and understand instructions

Full record on ClinicalTrials.gov

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