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Aptatek BioSciences, Inc. Receives FDA Breakthrough Device Designation for a Home-Based Test System that Enables Patients to Monitor Blood levels of Phenylalanine in Real Time

Aptatek BioSciences, Inc. a pioneer in home-based monitoring of small molecule biomarkers, announced that their PKU test system for real time monitoring of blood phenylalanine levels by phenylketonuria (PKU) patients has received Breakthrough Device designation from the FDA Center for Devices and Radiological Health (CDRH).

The Aptatek test measures blood levels of the amino acid phenylalanine on a portable instrument which patients can use at home. Granting the FDA breakthrough designation was based on Aptatek’s system enabling patients to test phenylalanine levels at home rather than making clinic visits or mailing blood samples to a central lab, a long-term goal of the PKU community, physicians treating PKU patients and companies developing therapies for PKU. The test system is supported by a cell phone app which allows users to evaluate changes in their phenylalanine levels over time.

PKU is an inherited disease in which patients do not adequately metabolize the amino acid phenylalanine, causing the phenylalanine to increase to potentially toxic levels in the blood. PKU patients must monitor their Phenylalanine levels throughout their lives to ensure that they maintain clinically safe levels, thus home-based monitoring has the potential to provide a major advancement in patient care.

“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,” said Christine S. Brown, Executive Director, National PKU Alliance.

“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,” said Michael Boyce-Jacino, Ph.D., CEO of Aptatek.

Aptatek was launched by IPGroup to commercialize novel small molecule sensing technology developed at Columbia University, specifically targeting tests which are otherwise only available as central lab tests requiring complex detection technologies such as mass spectrometry. By enabling equivalent testing on a small, portable system, Aptatek believes it can address areas of high unmet need, such as PKU, in metabolic disease, medication management and wellness.

About Aptatek

Aptatek is a mobile health company developing innovative systems combining novel sensing technology and innovative digital health tools to enable detection and monitoring of small molecule targets on a portable platform. The privately held company is commercializing technology developed by Columbia scientists and licensed from Columbia University by Aptatek and is based in Princeton, New Jersey.


The National PKU Alliance (NPKUA) is the national patient advocacy organization in the United States for people living the PKU. Our mission is to improve the lives of individuals with PKU and pursue a cure.

About IP Group

IP Group is a leading intellectual property commercialization company focused on evolving great ideas from its partner universities into world-changing businesses. The Group pioneered a unique approach to developing these ideas and the resulting businesses by providing access to business building expertise, capital, scientific insight and the supporting infrastructure.

In North America, IP Group works in close partnership with a select group of universities and U.S. Department of Energy Laboratories to identify ground-breaking technologies, rooted in hard science, which have the most promising commercial potential.

IP Group, which is listed on the Main Market of the London Stock Exchange under the symbol IPO, has a strong track record of success and its portfolio comprises holdings in early-stage to mature businesses across life sciences and technology.

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Last Updated: 29-Oct-2018