PheCheck™ Validation Study

August 24, 2026 updated by: Aptatek BioSciences, Inc
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate the performance of the PheCheck™ test for the rapid, quantitative detection of phenylalanine (Phe) direct from a capillary (fingerstick) sample. Results will be compared to reference testing from Dried Blood Spot Cards (DBS).

The PheCheck™ test performs a quantitative determination of phenylalanine in a self-collected or parent/guardian-collected capillary blood sample.

The analysis will evaluate the performance of the analyte concentration of phenylalanine in prospectively collected samples self-collected and tested by patients with PKU, measured by the PheCheck™ test as compared to the standard of care DBS testing performed by a reference lab

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Lurie Children's Hospital
        • Principal Investigator:
          • Erika Vucko
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Boston Children's Hospital
        • Contact:
        • Principal Investigator:
          • Stephanie Sacharow, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients 1 year or older with phenylketonuria (PKU) or hyperphenylalaninemia

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous enrollment in the study and has completed 3 study visits
  • Inability to read and understand instructions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of the PheCheck™ test for the detection of phenylalanine (Phe) concentration from capillary blood as compared to the reference method (DBS)
Time Frame: Day 1
The primary objective of this study is to evaluate the performance of the PheCheck™ (Aptatek Biosciences) test for the rapid, quantitative detection of phenylalanine (Phe) direct from a capillary (fingerstick) sample. PheCheck™ is a self-test to be performed by PKU patients. Results will be compared to reference testing from Dried Blood Spot Cards (DBS) tested in a designated reference laboratory. Phe results will be blinded to the study participant
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aptatek BioSciences, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2026

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

April 20, 2027

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-0023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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