PheCheck™ Validation Study

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).

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Key information

Conditions

Phenylketonuria (PKU) and Hyperphenylalaninemia Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Phenylketonurias

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PheCheck

Device

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

Dried Blood Spot Cards.

Diagnostic Test

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

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Catalina Suarez-Cuervo, MD

CONTACT

[email protected]

727-776-5880

Sponsors and collaborators

Lead sponsor

Aptatek BioSciences, Inc

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Apr 27, 2026
Registry last updated: Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed