by John R. Fischer
, Senior Reporter | May 03, 2023
GE HealthCare has introduced a new macrocyclic, non-ionic MR, gadolinium-based agent for enhancing and personalizing contrast-based scans in adults, adolescents and children of all ages, including neonates undergoing cranial and spinal MR exams and MR angiography, as well as whole-body imaging.
Pixxoscan, which is expected to be distributed in several European countries this year, will be available for whole-body imaging - to detect and classify lesions, including in the liver and kidneys, as benign or malignant. It adds to GE HealthCare's portfolio which includes macrocyclic Clariscan (gadoteric acid) and, also, Rapiscan which is used for stress cardiac MR procedures to help diagnose coronary artery disease and is an alternative for patients who cannot exercise.
“This extension to our portfolio means, we will be able to offer two leading macrocyclic molecules — Clariscan and Pixxoscan — to our customers in a number of European countries, offering radiology departments even more choice to suit their diagnostic needs,” said Mark Hibberd, chief medical officer of GE HealthCare pharmaceutical diagnostics, in a statement.
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Pixxoscan, for which Gadovist is the reference product, has a high relaxivity that makes it better at detecting, delineating, and characterizing several indications, and has twice the concentration of gadolinium ions, reducing its injection volume by half of other GBCAs. Additionally, its cage-like macrocyclic chelate, which encloses the gadolinium, quickly eliminates the gadolinium rather than releasing it in the body, relieving concerns about alleged gadolinium retention.
GE HealthCare will produce Pixxoscan in accordance with current Good Manufacturing Practices (cGMP), and rigorously test it at its primary and secondary manufacturing sites in Norway.
It will label and package it once approved, and ship it out through its standard distribution network to local markets in a wide range of encompassing glass vials, ready-assembled plastic prefilled syringes, and larger volume +PLUSPAK polypropylene bottles, which use flip-top lids to reduce the risk of, and downtime from, broken glass and ring-pull injuries, along with costs and environmental impact for customers.
The solution has already been authorized in Austria.