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PheCheck™ Validation Study

NCT07551921 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-08-25

No results posted yet for this study

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).

Conditions

  • Phenylketonuria (PKU) and Hyperphenylalaninemia

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 Sample read using an electronic reader. Results available within 1 hour

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

  • Aptatek BioSciences, Inc

    lead INDUSTRY

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2027-03-20
Completion
2027-04-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07551921 on ClinicalTrials.gov