Clinical Research Directory
Browse clinical research sites, groups, and studies.
PheCheck™ Validation Study
Sponsor: Aptatek BioSciences, Inc
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).
Key Details
Gender
All
Age Range
1 Year - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2026-05-20
Completion Date
2027-03-15
Last Updated
2026-04-27
Healthy Volunteers
No
Interventions
PheCheck
Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU. 1 fingerstick specimen collected at each study visit Sample read using an electronic reader. Results available within 1 hour
Dried Blood Spot Cards.
Laboratory-based reference method 1 fingerstick specimen at each study visit to collect 5 samples to fill 5 spots on the card. Card sent to a laboratory, results available within 72 hours