PheCheck is a handheld, Bluetooth-enabled investigational home monitoring system designed to measure phenylalanine from a fingerstick blood sample and deliver results to a smartphone app in minutes.

PheCheck is designed for clinical-grade monitoring. In pre-verification studies, precision was below 11.5% CV and accuracy was within ±5% of LC-MS/MS reference methods. Pivotal clinical study data is pending.

PheCheck uses DNA aptamer technology. Each cartridge contains an aptamer sensor designed to bind phenylalanine and generate a quantitative signal that is read by the device and displayed in the app.

No. PheCheck uses a whole-blood fingerstick sample processed immediately in the reader — not a dried blood spot mailed to a central lab. There is no mail-in step and no waiting for results to return from a central laboratory.

Aptatek is currently conducting a multi-site clinical validation study at Boston Children's Hospital, Lurie Children's Hospital, and UPMC. Following FDA 510(k) submission (targeted late 2026), the US commercial launch is planned for early 2027, subject to FDA clearance, initially through leading PKU metabolic centers. Join the waitlist to be notified when PheCheck becomes available.

When PheCheck receives FDA clearance, it is intended to be available by prescription from a metabolic specialist or PKU care team.

Following FDA clearance, Aptatek intends to pursue reimbursement through existing diagnostic and home monitoring pathways. Coverage is expected to develop over time, as it has for other home monitoring technologies.

Testing frequency will be determined by your prescribing physician based on your clinical situation. PheCheck is designed to support more frequent monitoring than is currently possible with centralized lab testing — from daily testing to several times per week, depending on clinical need.

Yes. The PheCheck app is designed to share results directly with your care team through connected clinician dashboards. When cleared, your physician and dietitian can see your Phe trends between appointments — enabling more informed, responsive care.

No. PheCheck is designed for home and portable use without refrigeration. The reader is battery-powered and Bluetooth-enabled. Test cartridges are designed for ambient storage.

PheCheck is designed to be compact enough to fit in a bag or purse and portable enough to use at home, at school, at work, or when traveling.

The DNA aptamer technology underlying PheCheck was developed in the laboratories of Dr. Milan Stojanovic and Dr. Tilla Worgall at Columbia University Medical Center. Aptatek was founded to translate that academic research into a commercial product for the PKU community.

We are developing the HomeCheck aptamer platform to measure multiple small‑molecule analytes. Aptatek has performed analytical development work on a variety of small molecules (for example: ammonia, creatinine, and selected drug compounds) and is pursuing additional test development for metabolic monitoring and medication‑management applications. Specific tests are made available only after completion of the required analytical and clinical validation and any applicable regulatory review or authorization; PKU (phenylalanine monitoring) is the first product we plan to offer.

Aptatek is a proud partner of the National PKU Alliance (NPKUA). Our patient engagement research reached more than 1,000 PKU patients and caregivers in 48 hours, the largest commercial intent survey of its kind in the PKU community. Patient and caregiver input has shaped every aspect of PheCheck design.