# A point-of-care device for phenylalanine determination

> **NIH NIH R44** · ANALYTICAL DIAGNOSTIC SOLUTIONS, INC. · 2020 · $944,873

## Abstract

Abstract
In Vitro Diagnostic Solutions (IVDS) proposes to develop the first and only FDA-approved point-of-care test
(POCT) for the determination of L-phenylalanine (Phe) from a finger or heel-stick sample. The PKU Now will
serve as a lifelong home monitoring device for PKU patients as well as a diagnostic testing device in lesser-
developed regions. It will provide immediate feedback on blood Phe levels, which will enable stricter dietary
compliance, substantially improve the quality of life for PKU patients and reduce healthcare costs. In Phase I
studies, we successfully resolved three critical issues. We eliminated tyrosine interference that could obscure
the measurement of Phe (Aim-1), eliminated hematocrit bias in the range of 32% to 60% (Aim-2) and
established concordance between the “PKU Now” and a laboratory reference method, Amino Acid Analysis
(AAA), in terms of accuracy and precision (Aim-3). PKU is the most common amino acid disorder, affecting 1 in
10,000 people. Most cases of PKU are detected by newborn screening in developed countries. PKU patients
must monitor and control their Phe levels throughout their lives to avoid severe neurological complications,
permanent intellectual disabilities and delayed development. Currently, Phe levels are measured at
laboratories via blood collection or blood spotted onto Dried Blood Spot Cards and sent for mass spec
analysis. This complicated process for monitoring Phe makes real time measurements impossible resulting in
non-compliance. “Currently, results from DBS testing can take days to weeks. This situation endangers the
health and well-being of tens of thousands of people with PKU. Such a device will open the way for newborn
screening of PKU in developing countries. Of all babies born around the world, more than 2/3 won’t be tested
for PKU” (PKU.org). IVDS’s proposed POCT, the “PKU Now”, will provide real-time blood Phe levels, thereby
enabling immediate intervention and improving the quality of life of thousands of people. To complete
development of the PKU Now, we will: Aim-1: Finalize assay development by evaluating bioactive
components; Aim-2: Transition from hand assembly to semi-automated assembly of test strips; Aim-3:
Develop and test synthetic controls; Aim-4: Validate the PKU Now using spiked blood samples
(following potential changes from Aim-1); and Aim-5: In two Blind Studies, we will establish
concordance between the data obtained from the PKU NowTM and data obtained from AAA using PKU
patient samples. These studies will be conducted under approved IRBs’ and will follow all HIPPA guidelines.
Once commercialized, the PKU NowTM will be the first POC diagnostic tool and home monitoring device for
PKU patients, enabling real-time intervention and treatment.

## Key facts

- **NIH application ID:** 10080660
- **Project number:** 2R44GM126593-02A1
- **Recipient organization:** ANALYTICAL DIAGNOSTIC SOLUTIONS, INC.
- **Principal Investigator:** Robert Harper
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $944,873
- **Award type:** 2
- **Project period:** 2018-04-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10080660

## Citation

> US National Institutes of Health, RePORTER application 10080660, A point-of-care device for phenylalanine determination (2R44GM126593-02A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10080660. Licensed CC0.

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