Status: Recruiting
PheCheck™ Validation 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).
Participants needed: 60
Trial details
Age: 1+Biological sex: AllType: ObservationalSponsor: Aptatek BioSciences, IncUpdated: Aug 25, 2026Locations: 2
Eligibility criteria
1 year or older and able to have a fingerstick blood collected [+2]
Previous enrollment in the study and has completed 3 study visits [+1]