PheCheck™ is an investigational device currently in clinical study. It has not been cleared or approved by the FDA and is not available for sale. Participation in the clinical study is limited to enrolled sites.
Bring metabolic monitoring closer to the patient
Aptatek is developing an aptamer-based sensing platform designed to make quantitative small-molecule biomarker monitoring more accessible outside the central laboratory.
Beginning with phenylalanine monitoring in PKU, we’re building partnerships across commercialization, therapeutic monitoring, clinical development, and companion diagnostics.
A new approach
to metabolic monitoring
Many clinically important biomarkers still rely on centralized laboratory testing, limiting how frequently they can be measured and how quickly results become available.
Aptatek is developing a different approach: portable, connected technology designed to bring quantitative monitoring closer to patients and care teams.
PheCheck is the first investigational application, focused on phenylalanine monitoring in PKU. The broader HomeCheck platform is being developed for additional small-molecule biomarkers and therapeutic monitoring applications.
OVERVIEW
Where we can work together
Aptatek is building partnerships to support the future commercialization of PheCheck and advance new applications of the HomeCheck platform across therapeutic monitoring and small-molecule diagnostics.
Bringing PheCheck to the PKU community
Following FDA clearance, PheCheck is intended for an initial U.S. launch through PKU metabolic centers. Aptatek is evaluating commercial partnerships that can help expand market access, clinician adoption, distribution, reimbursement, and geographic reach.
Partnership capabilities of interest:
- ✓PKU and metabolic clinic relationships
- ✓Rare disease commercial infrastructure
- ✓Market access and reimbursement
- ✓Specialty distribution
- ✓International market expansion
Connected monitoring for PKU therapeutic programs
More accessible phenylalanine monitoring could provide therapeutic programs with more frequent data between scheduled visits. Aptatek is exploring opportunities to integrate PheCheck across clinical development, patient support, treatment-response monitoring, and longitudinal evidence generation.
Partnership opportunities include:
- ✓Clinical development — evaluate home Phe monitoring within appropriate clinical study protocols
- ✓Patient support programs — explore connected monitoring alongside therapy
- ✓Longitudinal evidence generation — enable more frequent Phe data collection between scheduled visits
- ✓Treatment-response monitoring — evaluate monitoring applications that support assessment of therapeutic response
- ✓Companion and complementary diagnostics — explore co-development opportunities for future therapies
From biomarker need to monitoring solution
For therapeutic programs where biomarker measurement may play a role in patient selection, treatment response, or ongoing management, Aptatek is exploring companion and complementary diagnostic opportunities using its aptamer-based sensing platform.
Our co-development approach begins with the biomarker and intended clinical use, then defines the analytical, clinical, and regulatory pathway needed to advance a potential monitoring solution.
OPPORTUNITY
Extending the platform beyond PKU
PheCheck is Aptatek’s first investigational application of the HomeCheck platform. The broader platform is being developed to enable more accessible monitoring of small-molecule biomarkers that have traditionally depended on centralized laboratory testing.
For therapeutic developers, this creates opportunities to evaluate applications beyond PKU, including metabolic biomarkers, therapeutic drug monitoring, and future companion diagnostic programs.
Have a biomarker that is difficult to monitor outside the lab?
Built on science.
Advancing toward clinical use.
Regulatory momentum
PheCheck has received FDA Breakthrough Device Designation and is being evaluated in a multi-site clinical study.
Differentiated sensing technology
A DNA aptamer platform originating from Columbia University research and designed for quantitative detection of small-molecule biomarkers.
Deep PKU community engagement
Aptatek works with the National PKU Alliance and has conducted research involving more than 1,000 PKU patients and caregivers.
Platform potential beyond PKU
HomeCheck is being developed for additional small-molecule biomarkers and future therapeutic monitoring applications.