Grant will allow company to launch large-scale prospective validation study of METAglut1 test to help early diagnosis of rare De Vivo disease (Glut1 deficiency syndrome)

Metafora biosystems, a company developing diagnostic tests to detect abnormalities in cellular energetics, today announces that it has received a European grant of €3.2 million ($3.75M) as part of the phase 2 of the European Commission’s H2020 SME Instrument program.
 
This grant will allow Metafora to accelerate its clinical and regulatory development processes. In the third quarter of 2018 the company is launching a large-scale prospective validation study of METAglut1, its test to help early diagnosis of De Vivo disease (Glut1 deficiency syndrome). It has already obtained the necessary authorizations for this study from the French National Agency for the Safety of Medicines and Health Products (ANSM) and the French Committee for the Protection of Persons (CPP). The study will be carried out in collaboration with more than 40 neurology centers in France, including the Pitié Salpêtrière and Robert Debré (AP-HP) hospitals, and Laboratoire Cerba. It will last until 2020, with the results expected to be published early 2021.
 
Metafora also plans to start regulatory proceedings in various European countries and in the United States with the objective of marketing its diagnostic test more widely. The European grant will also help with international expansion.
 
The ‘SME Instrument’ program is highly selective, designed for innovative SMEs with a strong ambition to develop, grow and reach international markets. It is part of Horizon 2020, the European Commission’s research and innovation funding program running from 2014 to 2020.
 
“We are delighted that the European Commission has selected our project. This confirms the innovation brought by our breakthrough technology and its potential for application,” said Vincent Petit, CEO of Metafora. “This significant grant will allow us to position Metafora as a major new player in the market. It will help us get a foothold in the IVD (in-vitro diagnostics) market more easily, which will benefit the company’s next R&D projects as well as future products.”
 
METAglut1 is the first diagnostic test that Metafora has developed using its proprietary technology. It obtained the CE marking in 2017 and Forfait Innovation funding in April 2018. The company published initial results in the Annals of Neurology (A simple blood test expedites the diagnosis of glucose transporter type 1 deficiency syndrome.