The US-based Aptatek BioSciences, a mobile health company,was granted the breakthrough device designation from the USFDA for Devices and Radiological Health (CDRH) for its phenylketonuria (PKU) test system, which permits real-time monitoring of blood phenylalanine levels by PKU patients.

The breakthrough device designation was awarded as Aptatek’s system allows patients to test phenylalanine levels at home instead of visiting clinics or mailing blood samples to a central lab as the company’s PKU test lets patient’s measure blood levels of the amino acid phenylalanine with the help of a portable instrument at home.Patients can use a mobile phone app to assess changes in their phenylalanine levels over time.

“We are excited to receive Breakthrough Device designation for our portable, home-based monitoring system.” said Michael Boyce-Jasino, CEO of Aptatek. “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.”

PKU is an inherited disease, and people suffering from it do not sufficiently metabolize the amino acid phenylalanine. This leads to the phenylalanine increasing to potentially toxic levels in the blood.

It is mandatory for PKU patients to monitor their phenylalanine levels throughout their lives to confirm that they maintain clinically safe levels, and home-based monitoring can be a major advancement in patient care.

“This test could impact the quality of PKU management much like a glucometer has improved the quality of diabetes management.” said Christine Brown, executive director of the National PKU Alliance. “Clinical management of PKU would improve with an at-home test because results would be able to be acted upon with consultation of a medicalprofessional immediately and without delay.

Aptatekwas introduced by the IPGroupto commercialize innovative small molecule sensing technology developed at Columbia University, focusing on targeted tests which were otherwise only available as central lab tests.


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