PheCheck™ Validation Study

Conditions

• Phenylketonuria (PKU) and Hyperphenylalaninemia

Eligibility Criteria

Sex

ALL

Age

1 Year - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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).

Key Dates

First listed

Apr 27, 2026

Start date

Aug 20, 2026

Status verified

Aug 2026

Primary completion

Mar 20, 2027

Completion

Apr 20, 2027

Study Design

Enrollment

60 participants (estimated)

Arms

• Arm: 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

Primary Outcome Measure

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 ]

Central Contacts

• Catalina Suarez-Cuervo, MD
  727-776-5880
  [email protected]

Locations (2)

Find similar trials in Chicago, IL