PheCheck™ Validation Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Device
Study Type: Observational
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:
• 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
Locations
United States
Illinois
Lurie Children's Hospital
RECRUITING
Chicago
Massachusetts
Boston Children's Hospital
NOT_YET_RECRUITING
Boston
Contact Information
Primary
Catalina Suarez-Cuervo, MD
Clinicalstudies@lumosdiagnostics.com
727-776-5880
Time Frame
Start Date: 2026-08-20
Estimated Completion Date: 2027-04-20
Participants
Target number of participants: 60
Treatments
Patients with Phenylketonuria or Hyperphenylalaninemia
Device: PheCheck Test Description: Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU. 1 fingerstick specimen collected at each study visit Comparator: Dried Blood Spot Cards. 1 fingerstick specimen collected at each study visit
Related Therapeutic Areas
Sponsors
Leads: Aptatek BioSciences, Inc