Loargys Arginine Quantitation

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Test Introduction

The Loargys Arginine system measures arginine levels in people with Arginase 1 Deficiency (ARG1-D) who are treated with LOARGYS® (pegzilarginase). The Loargys Assay system is performed under an FDA Investigational Device Exemption (IDE) and is only for patients enrolled in the Clear Study.

Test Description

How  the Loargys Arginine Test System™ Works

 

The Loargys Arginine Test System consists of two components: the Nor-NOHA Blood Collection Tubes for blood sampling and the Loargys Arginine Assay for evaluating arginine concentration in plasma sampled using the Nor-NOHA Blood Collection Tube.

The Nor-NOHA Blood Collection Tube is intended for patients undergoing Loargys therapy to monitor the concentration of arginine in their blood. Tubes are non-sterile.

The Loargys Arginine Assay utilizes Ultra-High-Performance Liquid Chromatography (UHPLC) coupled to a triple quadrupole Mass spectrometer with multiple reaction monitoring (MRM).  The Loargys Arginine Test measures arginine levels in the plasma of ARG1-D patients receiving Loargys treatment to help guide pegzilarginase dosage adjustments, if needed, to bring plasma arginine levels within the normal range. Assay performance for the broader diagnosis or monitoring of patients with ARG1-D has not been evaluated. The device is not intended for any other purpose.

What is the Clear Study?

The CLEAR Study is a clinical research study designed to evaluate the safety of an investigational special blood testing system used during treatment with LOARGYS for people with ARG1-D. This study focuses on the safety of the investigational blood collection and testing process to measure arginine, not the actual medication (LOARGYS). LOARGYS has already been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ARG1-D. 

Test Ordering

The Loargys arginine Assay is only available to subjects enrolled in the Clear Study.

Sample Collection and Shipping Instructions

Blood samples are collected by CLEAR Study home health nurses at the patient’s home or another predetermined, convenient location. Samples are not collected by treating HCPs or clinic staff.