PheCheck Feasibility Study

CompletedOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

December 15, 2023

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2024

Conditions
Phenylketonurias
Interventions
DEVICE

PheCheck™

"Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU.~1 fingerstick specimen collected at each study visit"

DIAGNOSTIC_TEST

HPLC Amino Acid Analyzer

1 venous specimen collected at each study visit

DIAGNOSTIC_TEST

Dried Blood Spot Cards

capillary blood specimen collected at each study visit

Trial Locations (1)

15224

UPMC Children's Hospital of Pittsburgh, Pittsburgh

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Aptatek Biosciences

UNKNOWN

lead

Lumos Diagnostics

INDUSTRY

NCT05998109 - PheCheck Feasibility Study | Biotech Hunter | Biotech Hunter