Aptatek Biosciences, Inc., a clinical-stage diagnostics company developing connected, aptamer-enabled technologies for decentralized metabolic monitoring, today announced that patient enrollment is underway in the PheCheck™ Validation Study (NCT07551921), advancing the company’s lead investigational program into formal clinical validation.

The prospective study is evaluating PheCheck in people with phenylketonuria (PKU) and is designed to compare the performance of the investigational system with laboratory-based dried blood spot (DBS) reference testing. The study is expected to generate clinical evidence intended to support Aptatek’s planned FDA premarket submission.

PheCheck has received Breakthrough Device Designation from the U.S. Food and Drug Administration. The system combines Aptatek’s DNA aptamer-based sensing technology with a reusable electronic reader, single-use test cartridge and smartphone-connected application being developed for quantitative phenylalanine (Phe) measurement for home-based self-testing.

“Enrollment of participants moves PheCheck into an important clinical evidence-generation stage,” said Michael Boyce-Jacino, PhD, Chief Executive Officer of Aptatek Biosciences. “We have built the system, completed preclinical testing and are now evaluating PheCheck against laboratory reference testing in people living with PKU. The resulting clinical evidence is intended to support our planned FDA submission and represents an important step in advancing both PheCheck and the broader HomeCheck platform.”

People living with PKU require ongoing monitoring of Phe levels as part of managing their condition. Current Phe monitoring commonly involves collecting a blood sample that is analyzed by a centralized laboratory, which may be geographically distant from the patient. This process can create delays between sample collection and availability of the result, potentially limiting timely decision-making in the ongoing management of PKU. PheCheck is being developed to enable quantitative Phe measurement at home, with results available in minutes.

The PheCheck Validation Study is expected to enroll approximately 60 participants one year of age and older with PKU. The prospective, observational cohort study is designed to evaluate the performance of PheCheck for rapid, quantitative measurement of Phe when testing is performed by study participants or their caregivers using a capillary fingerstick blood sample.

At each study visit, fingerstick blood samples are collected for testing with the investigational PheCheck system, while a DBS sample is obtained for laboratory reference testing. PheCheck generates a quantitative Phe result in minutes, while the DBS specimen is sent to a designated laboratory for comparative reference analysis. This study design will allow investigators to evaluate the performance of PheCheck relative to established laboratory-based testing.

“For patients and families living with PKU, Phe measurement is an important and recurring part of managing the condition,” said Erika Vucko, MNS, FNP-BC, AGN-BC, director of the PKU Clinic at Ann & Robert H. Lurie Children’s Hospital of Chicago and a principal investigator of the study. “This study allows us to evaluate PheCheck directly against laboratory reference testing and understand its performance when fingerstick samples are collected and tested by patients and caregivers themselves. It’s an important technology to evaluate rigorously.”

“Home monitoring of Phe levels has been a critical goal of the PKU community and clinicians, and we are excited to evaluate the performance of the PheCheck system and its potential to address this unmet need,” added Stephanie Sacharow, MD, director of the Harvey Levy Program for Phenylketonuria and Related Conditions at Boston Children’s Hospital.

The study is currently being conducted at two sites: Ann & Robert H. Lurie Children’s Hospital of Chicago and Boston Children’s Hospital, with Erika Vucko and Stephanie Sacharow, MD, serving as site principal investigators, respectively.

Additional information about the PheCheck Validation Study is available at ClinicalTrials.gov under NCT07551921.

PheCheck is investigational, has not been cleared or approved by the FDA and is not commercially available.

About Aptatek Biosciences

Aptatek Biosciences, Inc. is a Columbia University spinout developing connected, aptamer-enabled diagnostic technologies for decentralized metabolic monitoring. The company’s lead investigational program, PheCheck, combines DNA aptamer-based sensing, a reusable electronic reader, single-use test cartridges and a smartphone-connected application and is the first application of its HomeCheck platform, a shared device, cartridge, assay, software and data architecture designed to support potential future applications in metabolic and therapeutic monitoring.

For more information, visit aptatek.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the clinical evaluation of PheCheck, anticipated study enrollment and timing, product-development activities, future regulatory activities, potential capabilities and applications of PheCheck and the HomeCheck platform, and commercialization plans. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Aptatek undertakes no obligation to update forward-looking statements except as required by applicable law.

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