American mobile health company Aptatek BioSciences has received breakthrough device designation from the US FDA Center for Devices and Radiological Health (CDRH) for its phenylketonuria (PKU) test system, which allows real time monitoring of blood phenylalanine levels by PKU patients.
The Aptatek test enables patients to measure blood levels of the amino acid phenylalanine on a portable instrument at home.
The breakthrough device designation was granted as the Aptatek’s system enables patients to test phenylalanine levels at home instead of visiting clinics or mailing blood samples to a central lab.
Patients can use a mobile phone app to evaluate changes in their phenylalanine levels over time.
Aptatek CEO Michael Boyce-Jacino said: “We are excited to receive Breakthrough Device designation for our portable, home-based monitoring system.
“This is a key milestone toward our goal of enabling smart-home monitoring of critical small molecule biomarkers for metabolic disease, medication management and wellness.”
People suffering from PKU, an inherited disease, do not adequately metabolize the amino acid phenylalanine. This results in the phenylalanine increasing potentially toxic levels in the blood.
As PKU patients are required to monitor their phenylalanine levels throughout their lifetime to ensure that they maintain clinically safe levels, home-based monitoring can provide a major advancement in patient care.
National PKU Alliance executive director Christine Brown said: “We believe an at-home test will be a critical and life changing tool in how patients living with PKU can more effectively manage the condition in the future.
“This test could impact the quality of PKU management much like a glucometer has improved the quality of diabetes management.
“Clinical management of PKU would improve with an at-home test because results would be able to be acted upon with consultation of a medical professional immediately and without delay.
“The NPKUA strongly believes in the benefits that a home test for phenylalanine levels will have in improving the quality of treatment and care for patients living with PKU.”
The IPGroup launched Aptatek to commercialize novel small molecule sensing technology developed at Columbia University, primarily targeting tests which are otherwise only available as central lab tests.