Metafora Biosystems secures reimbursement in France for first IVD to help diagnose Glut1 deficiency syndrome

• METAglut1^TM obtains universal national coverage by French National Health Insurance as of February 22, 2024

• Nationwide, patients with suspected Glut1 deficiency syndrome will benefit from thisinnovative test to avoid medical wandering

• First product shows clear clinical benefits of Metafora technology platform

• New assays in oncology under development

Paris, France, March 11, 2024 – Metafora Biosystems, a healthtech company developing an analysis platform for single-cell metabolism characterization, announces the official coverage by the French national health insurance service of METAglut1™, its test for the early diagnosis of Glut1 Deficiency Syndrome (Glut1DS), a rare neurometabolic disorder.

According to the French Ministry of Health and Prevention, METAglut1 is the first product to secure a definitive reimbursement through the Forfait Innovation program. This was critical in supporting a 30-month study to demonstrate the efficacy of METAglut1 in the early detection of Glut1DS, undertaken at more than 30 pediatric and adult neurology centers in France. In May 2023, the French National Authority for Health (HAS – Haute Autorité de Santé) issued a positive recommendation for universal national coverage.

“This reimbursement is a significant milestone for patients, healthcare providers and the broader medical community,” said Vincent Petit, CEO of Metafora. “By securing reimbursement, we can ensure broader and more equitable access to this life-changing diagnostic tool, empowering healthcare professionals to effectively identify Glut1DS and promptly initiate appropriate treatment strategies.”

METAglut1 is now available through two testing labs in France, namely the Bichat Hospital pharmacology laboratory (APHP, Paris) and Laboratoire Cerba (Frépillon). This ensures optimal nationwide coverage of prescriptions.

This is a significant milestone for the company, as it demonstrates the potential of Metafora’s technology platform, which enables medical professionals to measure changes in single-cell metabolism and determine ‘cell metabolic fitness’ or lack thereof, which is a telltale sign of disease. METAglut1 is designed to diagnose a neurometabolic disorder; meanwhile Metafora is also conducting research and development to design and validate new assays to characterize the metabolic fitness of tumor and immune cells in a series of cancers.

Metafora aims to develop a range of assays to better diagnose and prognose within the booming immuno-oncology market.

About Glut1 deficiency syndrome and METAglut1^TM – diagnose to cure

Glut1 Deficiency Syndrome (Glut1DS), also known as De Vivo disease, is a rare neurological disease affecting an estimated 30,000 people in Europe and the US, of which less than 2,000 are currently diagnosed. Glut1-deficient patients live with an impaired glucose uptake by brain cells, leading to epileptic seizures, movement disorders and often developmental delay. Treatment is relatively straightforward, requiring a high-fat ketogenic diet, which significantly improves symptoms in patients, especially when initiated in early development.

A multicenter validation study, supported by the French Society of Neuropediatrics (SFNP) and the French Society for the Study of Innate Metabolic Diseases (SFEIM), has been published in Neurology. It shows that METAglut1 resulted in almost 100% specificity and 80% sensitivity. METAglut1 identifies affected children and adults within 48 hours of a blood test, significantly faster than the current diagnostic tests; these rely on a lumbar puncture, which is an invasive procedure, and on complex genetic analysis.

METAglut1 is the result of a collaboration between Metafora Biosystems, over 30 clinical trial sites including the teams at Greater Paris University Hospitals (AP-HP), Cerba and the French National Centre for Scientific Research (CNRS).

About Metafora Biosystems

Metafora Biosystems is a healthtech company developing a platform for single-cell metabolism monitoring. METAglut1™ is its first diagnostic test. Metafora’s technology enables medical professionals to measure changes in single-cell metabolism and determine ‘cell metabolic fitness’ or lack thereof, which is a telltale sign of disease, especially in neurology, cancer and inflammatory diseases. The company has forged key partnerships for the development of new diagnostic tests in oncology. Additionally, Metafora is working on increasing the clinical efficacy of cell therapies and reducing manufacturing costs.

Metafora has also developed METAflow™, a cloud-based cytometry data analysis software powered by AI. This solution brings unmatched robustness and a user-friendly interface that yields objective, reproducible and actionable results for users, who face increasingly large and complex datasets generated by booming single cell technologies. The first generation of METAflow is due to be launched on the research market soon, with developments underway to turn it into a clinical grade solution.

Metafora, headquartered in Paris (France), with a staff of 27, has received grants from Bpifrance to develop its technology platform and funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 806038. The company is a laureate of the European Commission’s EIC Accelerator program.

www.metafora-biosystems.com

[Decision of January 2, 2024, JORF n°0038 du 15 février 2024, texte n°18]