Glut1 Deficiency Syndrome

Green light from HAS to facilitate reimbursement of METAglut1TM test in France Decision paves the way for adoption and reimbursement of the test in Europe and the U.S. PARIS--(BUSINESS WIRE)-- METAFORA biosystems, today announces that the Haute Autorité de Santé (HAS), the French Health Technology Agency, has issued a recommendation for insurance coverage of METAglut1TM, a test for the early diagnosis of De Vivo disease (or GLUT1 deficiency syndrome), a rare neurometabolic disorder. The HAS conducted a thorough evaluation of METAglut1TM, which included an assessment of its clinical performance and clinical utility. The evaluation concluded that METAglut1 is a valuable addition to the diagnostic arsenal for Glut1 DS, and was ascribed a high clinical added value. Vincent Petit, CEO of Metafora, said, “We are extremely proud to obtain HAS approval for METAglut1, a true milestone for the company and our partners, and not least for GLUT1 deficient patients. This rare neurometabolic disease is highly underdiagnosed, and we expect that METAglut1’s availability will increase awareness and help physicians to diagnose the disease earlier. We are grateful for the Forfait Innovation of the French Ministry of Health, which has allowed us to bring a multi-year prospective study to its successful conclusion. We look forward to making METAglut1 available to patients and clinicians in France and other large European countries, while we are actively exploring ways to launch the test in the U.S. as well.” Principal Investigator Prof. Fanny Mochel, Head of the Reference Centre for Adult Neurometabolic Diseases at AP-HP Pitié-Salpêtrière Hospital said, “METAglut1 quickly and accurately diagnoses GLUT1 deficiency syndrome. Its reimbursement will be of major benefit to physicians, pediatricians and neurologists, but especially to patients with this rare disease, as its early diagnosis is essential for targeted therapeutic management that can significantly improve the symptoms and daily lives of patients and their families.” About De Vivo disease & METAglut1TM – diagnose to cure De Vivo disease, or GLUT1 deficiency syndrome, is a rare and debilitating neurological disease. An estimated 30,000 people suffer from the GLUT1 deficiency syndrome in Europe and the USA, of which less than 2,000 are currently diagnosed. GLUT1-deficient patients suffer from an impaired glucose uptake by brain cells, leading to epileptic seizures, ataxia and often developmental delay. Uniquely, unlike for many genetic diseases, treatment is relatively straightforward, requiring a high-fat diet (known as a ketogenic diet), which significantly improves symptoms in patients. Early diagnosis is therefore of the essence. A multicenter validation study supported by the French Society of Neuropediatrics (SFNP) and the French Society for the Study of Innate Metabolic Diseases (SFEIM), was presented at the 3rd European GLUT1D Conference in 2021 and is accepted for a forthcoming publication in a leading scientific journal. It demonstrated that METAglut1 resulted in almost 100% specificity and a sensitivity of approximately 80%. METAglut1 identifies affected children and adults within 48 hours, unlike current diagnostic tests which rely on a lumbar puncture, an invasive procedure, and complex genetic analysis. METAglut1 is the result of a collaboration between METAFORA biosystems, the teams at Greater Paris University Hospitals (AP-HP), over 30 clinical trial sites, Cerba HealthCare, a clinical testing laboratory responsible for supporting the rollout of METAglut1 in France, and CNRS. METAglut1 is the first product to receive a recommendation through the Forfait Innovation program supported by the French Ministry of Solidarity and Health. The Forfait Innovation was critical in supporting a 30-month study in over 60 pediatric and adult neurology centers in France to demonstrate the efficacy of METAglut1 for the early detection of the GLUT1 deficiency syndrome. About METAFORA biosystems Metafora biosystems is a health-tech company based in Paris with 30 employees, developing a single-cell analysis platform. This platform allows 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. METAglut1 is a first diagnostic test for the early diagnosis of De Vivo disease, a rare pediatric neurometabolic disorder. The company has forged key partnerships, notably with Sebia, a leading player in in vitro diagnostics, for the development of new diagnostic tests in oncology, and of a solution to increase the clinical efficacy of cell therapies and reduce manufacturing costs. Metafora has also developed METAflowTM, a cytometry data analysis software with unmatched robustness and a user-friendly interface that yields objective, reproducible, and actionable results from the increasingly large and unwieldy data sets generated by conventional, mass or spectral cytometry. A first research use only version will be launched by mid-2023, and developments are ongoing to turn METAflow into a clinical grade solution. Metafora has received grants to develop its technology platform from Bpifrance and funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 806038, and is laureate of the EIC Accelerator program from the European Commission. View source version on businesswire.com: Contacts For further information: Vincent Petit, CEO Phone: +33 6 76 71 61 14 Email: vincent.petit@metafora-biosystems.com Source: METAFORA biosystems View this news release online at:

Launch in Europe & U.S. for limited number of RUO licensees Global launch expected later in spring PARIS & CHICAGO--(BUSINESS WIRE)-- METAFORA biosystems, today announces the launch of METAflow, its digital flow cytometry platform, into the RUO market. METAflow offers the power of a highly advanced unsupervised algorithm suite through a simple, elegant workflow accessible to any user, from beginners to advanced users. A cloud-based software enabling automated multidimensional clustering of flow cytometry data, METAflow marks a dramatic advance over existing, suboptimal solutions, regardless of data processing skills. Vincent Petit, CEO of Metafora, said, “Scientists and biologists today analyze flow cytometry data either manually, through a so-called gating strategy, or through a mix of manual data preprocessing and the implementation of a series of algorithms. Multiple trial and error runs are required before finding the right settings, and getting relevant results. In contrast, METAflow offers a faster, more robust and intuitive way to reach the desired populations. We look forward to rolling out METAflow to at first a limited number of RUO licensees, and setting the stage for accessing the research community at large later this spring.” Starting today, a limited number of licensees from Europe and the U.S. will start working with METAflow. The feedback of these first customers will serve to prepare for the global roll-out of METAflow in spring, while simultaneously scaling the support team of application and digital specialists and the opening a U.S. office. About METAflow METAflow is a flow cytometry data analysis software with unmatched robustness and a seamless, comprehensive, user-friendly interface. Metafora believes that METAflow will allow hundreds of thousands of flow cytometrists to move from cumbersome sequential manual gating to automated multidimensional clustering to obtain more objective data in a much shorter timeframe. METAflow provides objective, reproducible, traceable results, all in a collaborative digital platform that empowers users to mine and retrieve the best from increasing data sets generated by conventional, mass or spectral cytometry. After a successful features’ showcase during CYTO22 and ESSCA conferences, and a year of continuous development through an early access program, METAflow is now ready to enter the RUO market. To go beyond the RUO market, Metafora is developing, partly financed through the EIC Accelerator Program, a clinical grade version for use in clinical research and in routine settings. About Metafora METAFORA biosystems has developed METAflow, a flow cytometry data analysis software with unmatched robustness and a user-friendly interface that yields objective, reproducible, and actionable results from the increasingly large and unwieldy data sets generated by conventional, mass or spectral cytometry. METAflow in combination with Metafora’s proprietary reagents underpins METAbolism, the company’s IVD activity. METAglut1 is a first diagnostic test for the early diagnosis of De Vivo disease, a rare pediatric neurometabolic disorder. The company is developing a number of oncology diagnostics as well as a solution to increase the clinical efficacy of cell therapies and reduce manufacturing costs.