U.S., April 28 -- ClinicalTrials.gov registry received information related to the study (NCT07551921) titled 'PheCheck™ Validation Study' on April 15.
Brief Summary: 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).
Study Start Date: May 20
Study Type: OBSERVATIONAL
Condition:
Phenylketonuria (PKU) and Hyperphenylalaninemia
Intervention:
DEVICE: PheCheck
Quantitative, single-use, rapid test Intended for hom...