A Self-test Home-use Blood Phenylalanine Monitoring System Under the Brand Name Egoo Phe System Has Been Developed for Measurement of Phenylalanine (Phe) in Individuals Diagnosed With Phenylketonuria (PKU): The Study Purpose is to Evaluate Accuracy and Usability

The Egoo Phe System is intended to be used by Healthcare Professionals in the hospital, for near-patient testing in the home of the PKU patients, and for self-testing guided by the manufacturer's instructions-for-use and after being trained by healthcare professionals.

Currently, no home-based method exists for convenient and timely monitoring of blood phenylalanine (Phe) levels. The standard practice is for patients to collect their own blood samples on a sample collection filter paper. These dried blood spot samples are posted to the hospital. The laboratories then give the results to the dietitians within 2 working days. The dietitians report the results to the patients' caregivers the same day the results become available. However, the process may take anything from 3 to 7 days, dependent on the reliability of the postal system. This delay in feedback prevents timely adjustment of dietary treatment.

Research studies, clinical guidelines, and the PKU patient organizations have highlighted a need for more frequent blood Phe testing and more timely/real-time results for the better management and treatment of PKU. Many of these studies and reports have outlined the critical need for a simple, rapid, and accurate method for monitoring Phe blood levels, especially during the first years of life. A number of these studies have also indicated that a home monitor could make management of the condition easier and more effective. In particular, the immediate, and possibly daily, feedback supplied by such a monitor would allow for better dietary adjustments so that Phe blood levels could be more consistently maintained. A survey of PKU patients and their primary caregivers have highlighted the potential utility of a home monitor in managing PKU. A large majority of the respondents believed a home monitor would facilitate better management of PKU through more regular and timely feedback. Therefore, a more accessible and convenient method of testing and monitoring blood Phe levels on a regular schedule with immediate results at home would greatly improve the management of PKU.