Launch of our first innovative IVD test METAglut1™ to aid the diagnosis of Glut1DS developed with our partner CERBA HealthCare
February 2, 2017
Results of our first study with AP-HP and the ICM on our innovative IVD test METAglut™ published in Annals of Neurology
June 12, 2017
February 15, 2017.
[NEWS] Company ; METAglut1™
We are proud to announce that the METAglut1™ has been CE marked since February 2017. This significant milestone marks a new era in the diagnostic landscape for GLUT1DS, providing a reliable and efficient tool for healthcare professionals.
METAglut1™ is our first IVD blood test designed to aid in the early diagnosis of Glut1 Deficiency Syndrome (Glut1DS), also known as De Vivo Disease. This rare neuro metabolic disorder can have a profound impact on the lives of affected children.
We believe that our diagnostic tool represents a significant advancement in identifying the condition, which can have profound implications for affected individuals and their families.
Importance of CE marking
CE marking is a crucial indicator of a product’s compliance with European health, safety, and environmental protection standards.
For medical devices like the METAglut1™ test, CE approval signifies that the product has undergone rigorous assessment and meets the essential requirements set forth by the European Commission. This not only ensures the test’s safety and efficacy but also builds trust among healthcare providers and patients.
The CE mark enables us to offer the METAglut1™ test for routine clinical use across Europe. This approval facilitates wider access to cutting-edge diagnostic technology, allowing healthcare professionals to confidently implement the test in their practices. By aligning with stringent regulatory standards, we demonstrates our commitment to quality and patient safety.
How METAglut1™ will transform diagnostics
The METAglut1™ test is distinguished by its fully automated process, which includes seamless data analysis achieved through advanced flow cytometry technology. Utilizing innovative algorithms, the test enables rapid and accurate detection of metabolic defects in patients, ensuring a fast and secure diagnostic experience.
As our first completely automated quantitative cytometry test to receive CE marking, METAglut1™ is set to revolutionize routine medical practices for Glut1DS patients. It is specifically designed for use in patients presenting with a range of neurological symptoms, including epileptic seizures and movement disorders.
The CE marking allows us to collaborate with healthcare institutions and practitioners across Europe, fostering partnerships that drive innovation in the field of neurology. By making the METAglut1™ test widely available, we hope to improve early diagnosis and treatment for patients.
Future expansion and beyond
As we celebrate the success of the METAglut1™ test receiving the CE marking, we are setting our sights on the U.S. market as our next step. We are committed to navigating the regulatory and market access pathways necessary to bring this groundbreaking test to healthcare providers and patients in the United States as soon as possible.
In addition to expanding our geographic reach, we also aim to leverage our METAbolism platform to develop other in vitro diagnostic tests for various applications and conditions, particularly in oncology and metabolic disorders. By diversifying our diagnostic offerings, we strive to address a broader spectrum of health challenges, ultimately contributing to improved patient outcomes across multiple medical fields.
Together, we are committed to advancing medical diagnostics and improving patient outcomes in the field of neurology.
