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Metafora Biosystems Receives €3.2M to Develop Diagnostic for De Vivo Disease

NEW YORK (360Dx) – Metafora Biosystems said today that it has received a €3.2 million ($3.8 million) grant as part of the second phase of the European Commission H2020 SME Instrument program to enable it to accelerate clinical and regulatory development and international expansion.

The company said that in the third quarter of 2018 it expects to launch a large-scale prospective validation study of METAglut1, an automated flow cytometry test to help with early diagnosis of De Vivo disease, which is associated with a deficiency of the glucose transporter type 1 (GLUT1) protein that transports glucose across the blood-brain barrier.

The firm noted that it has obtained the necessary authorizations for the study from the French National Agency for the Safety of Medicines and Health Products and the French Committee for the Protection of Persons. It will conduct the study in collaboration with more than 40 neurology centers in France including the Pitié Salpêtrière and Robert Debré hospitals, and Laboratoire Cerba.

Metafora said that it expects the validation study for its blood-based test, which uses automated flow cytometry to measure the expression levels of the GLUT1 protein, will continue until 2020, and it expects to publish the results of the study in early 2021.

With the objective of more broadly marketing its diagnostic test, Metafora also plans to start regulatory proceedings in European countries and the US. Vincent Petit, CEO of Metafora, said in a statement that the grant will benefit the company’s next R&D projects and future products.

METAglut1 obtained CE marking in 2017 and Forfait Innovation funding in April this year. Metafora published initial results for the test in the Annals of Neurology in July 2017.

De Vivo disease is a rare, debilitating illness, relatively unknown in the medical profession. In the European Union and US, there are around 12,000 cases of the disease, and 80 percent remain undiagnosed, according to Metafora.

The SME instrument program is designed for innovative small- and medium-size enterprises with ambitions to develop, grow, and reach international markets. It is part of Horizon 2020, the European Commission's research and innovation funding program running to 2020.