PheCheck™ is an investigational device currently in clinical study. It has not been cleared or approved by the FDA and is not available for sale. Participation in the clinical study is limited to enrolled sites.
Clinical Studies
Advancing at-home phenylalanine monitoring for people living with PKU
PheCheck™ is an investigational home phenylalanine monitoring system currently being evaluated in clinical studies.
Aptatek is studying the performance and usability of PheCheck as it works to bring phenylalanine monitoring closer to home for people living with phenylketonuria (PKU).
View Current Study ↓Living with PKU requires ongoing phenylalanine monitoring
Phenylketonuria is an inherited metabolic disorder in which the body cannot properly break down phenylalanine, an amino acid found in protein-containing foods.
Managing PKU requires regular monitoring of phenylalanine levels to help patients, families and healthcare providers understand how diet and treatment are affecting Phe levels over time.
Today, testing typically involves collecting a blood sample and sending it to a laboratory for analysis. Results can take several days to become available, creating a gap between testing and the information needed to help guide management decisions.
PheCheck is being developed to help close that gap.
PheCheck is designed to provide quantitative phenylalanine measurements from a fingerstick blood sample using a portable reader and single-use test cartridge.
Learn More About PheCheck →Current Clinical Study
Status
Recruiting
Name
PheCheck™ Validation Study
Condition
Phenylketonuria (PKU) and hyperphenylalaninemia
Study Type
Observational
Age
1 year and older
What the study is evaluating
The study is evaluating the performance of PheCheck for the rapid, quantitative measurement of phenylalanine from a fingerstick blood sample.
PheCheck results are being compared with dried blood spot testing performed by a reference laboratory. The study also evaluates use of the system by participants or their parents or guardians.
View Study on ClinicalTrials.gov →Study status and details may change. ClinicalTrials.gov provides the most current study information.
Interested in participating?
People who meet the study eligibility requirements may be able to participate in the PheCheck Validation Study.
ClinicalTrials.gov provides the most current information about study eligibility, recruiting status and participating locations.
See Eligibility & Study Locations →What does participation in a clinical study involve?
Clinical studies help researchers evaluate the performance, usability and safety of investigational medical devices.
People considering participation receive information about the study, what participation involves, potential risks and benefits, and their rights as research participants.
Participation is voluntary, and individuals can ask the study team questions before deciding whether to take part.
Learn More on ClinicalTrials.gov →Earlier Clinical Research
PheCheck™ Feasibility Study
An earlier feasibility study evaluated PheCheck for the rapid, quantitative measurement of phenylalanine from capillary blood.
The study compared PheCheck measurements with laboratory-based amino acid analysis and evaluated ease of use by study participants.
View Study →Learn more about PheCheck™
PheCheck is an investigational home phenylalanine monitoring system being developed for people living with PKU.
