ClinicalTrials.gov record NCT07551921

PheCheck™ Validation Study

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 6, 2026

PheCheck™ Validation Study

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age1 year old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study evaluates the PheCheck™ rapid test for measuring phenylalanine (Phe) from a fingerstick sample in people with PKU or hyperphenylalaninemia. Self- or guardian-collected capillary blood is tested on PheCheck™ and also collected on dried blood spot (DBS) cards for reference laboratory testing. PheCheck™ results are compared with DBS results and are blinded to participants.

What it is studying. The study tests how quantitative Phe readings from the PheCheck™ device using a capillary (fingerstick) blood sample compare with standard laboratory results from dried blood spot (DBS) testing.

What the researchers hope to learn. To evaluate the performance and quantitative accuracy of the PheCheck™ rapid fingerstick test for measuring phenylalanine compared with the laboratory DBS reference method.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • PheCheck
Diagnostic test
  • Dried Blood Spot Cards.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

At each study visit you (or your child) will give a small fingerstick blood sample for two tests: a PheCheck™ device test (self- or parent/guardian-collected) and a dried blood spot (DBS) card (fingerstick to fill spots on the card). The PheCheck sample is read with an electronic reader and results are available within about 1 hour; the DBS card is sent to a reference laboratory with results available in about 72 hours. PheCheck testing is quantitative and performed by the participant; Phe results from the study device will be blinded to participants.

How the study is structured. A prospective observational cohort study. People with PKU or hyperphenylalaninemia provide a fingerstick blood sample at study visits, perform or have performed a PheCheck™ self-test reading, and also provide a dried blood spot (DBS) card that is sent to a reference laboratory. Results from the PheCheck™ device are compared with the DBS laboratory results; PheCheck™ results are blinded to the participant.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on phenylketonuria

Clinical trials38 trials listed for phenylketonuriaEvery trial the registry lists for phenylketonuria, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in phenylketonuria researchLatest monthly update: September 2026. Includes: Diet supply gaps. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Aug 20, 2026
Primary completion
Mar 20, 2027 (estimated)
Study completion
Apr 20, 2027 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Aug 25, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Aptatek BioSciences, Inc

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
standard of care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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