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PheCheck™ Validation Study

Who can join

Ages 1 and older · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

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

About the study

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).

What is being tested

• PheCheck (device)
• Dried Blood Spot Cards. (diagnostic test)

Sponsor: Aptatek BioSciences, Inc · Participants: 60 · Started: Aug 20, 2026

Contact the study team

• Catalina Suarez-Cuervo, MD · Phone: 727-776-5880

Official record on ClinicalTrials.gov — NCT07551921

Locations in the U.S.

Conditions

• Phenylketonuria

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.