Periodic Reporting for period 2 - METAdiag (Detecting serious diseases due to abnormal cellular energetics)
Reporting period: 2019-04-19 to 2021-06-18
METAFORA develops a disruptive blood-based In Vitro Diagnostic platform called METAdiag. METAdiag monitors cells’ energetic needs thanks to unique, proprietary biomarkers (Receptor Binding Domains or RBDs), able to quantify nutrient transporters used by cells to feed on glucose, amino acids, vitamins and other essential nutrients at the cell’s surface.
Cutting edge algorithms using Artificial Intelligence to handle big data participate in generating actionable results for physicians’ routine clinical practice. METAglut1TM is a first test developed to fill a medical unmet need, i.e. the easy and early diagnosis of a debilitating but curable neuro-metabolic disease in children, the Glut1 Deficiency Syndrome. Following encouraging results of a pilot study published in a leading scientific journal, the CE-mark of the test and a first commercial agreement with CERBA Healthcare, a leading medical testing laboratory, METAFORA successfully concluded a prospective validation study of METAglut1TM in 33 hospitals in France (one of the main objectives of our project). In addition to this validation study, we also obtained consistent positive results from smaller clinical studies in Germany and Italy, paving the way to the international deployment of the test. At the end of phase 2 of the project, we are thus in prime position to a go-to-market status by the end of 2021 (TRL 9 for METAglut1TM).
After 7 years of commercialization, we expect sales of close to 317 000 tests, at an end-user price of 300 € per test, including analysis and report. By 2025, we expect to exceed breakeven with an EBITDA of over € 1m. After a 7-year commercialization phase, we will have generated close to € 50m in cumulated revenues.
Cutting edge algorithms using Artificial Intelligence to handle big data participate in generating actionable results for physicians’ routine clinical practice. METAglut1TM is a first test developed to fill a medical unmet need, i.e. the easy and early diagnosis of a debilitating but curable neuro-metabolic disease in children, the Glut1 Deficiency Syndrome. Following encouraging results of a pilot study published in a leading scientific journal, the CE-mark of the test and a first commercial agreement with CERBA Healthcare, a leading medical testing laboratory, METAFORA successfully concluded a prospective validation study of METAglut1TM in 33 hospitals in France (one of the main objectives of our project). In addition to this validation study, we also obtained consistent positive results from smaller clinical studies in Germany and Italy, paving the way to the international deployment of the test. At the end of phase 2 of the project, we are thus in prime position to a go-to-market status by the end of 2021 (TRL 9 for METAglut1TM).
After 7 years of commercialization, we expect sales of close to 317 000 tests, at an end-user price of 300 € per test, including analysis and report. By 2025, we expect to exceed breakeven with an EBITDA of over € 1m. After a 7-year commercialization phase, we will have generated close to € 50m in cumulated revenues.
We have achieved significant work and milestones on the METAglut1TM clinical validation study:
- A multicentric clinic validation study, involving 33 centres in France and enrolling 625 patients, has been successfully completed with a positive outcome confirming the performance of the test (in accordance with the French health authorities’ requirements: HAS).
- In addition to the clinical validation study, a health economic study gathering economic evidence on the burden represented by the GLUT1DS affection on top of its medical burden is finalised with the help of CEMKA and will be submitted to the HAS by the end of 2021 in order to obtain the reimbursement of METAglut1TM in France.
- 2 other retrospective studies have been completed: in Germany (56 patients enrolled), where the cytometry platform has been installed and running at Heidelberg’s Children hospital, and in Italy (17 patients enrolled) at the Milan Children Hospital where the platform is planned to be installed, making the test available in these countries.
- A first very positive pre-submission meeting has been held with the FDA in November 2018 to discuss the submission of a de novo dossier in the USA. This will enable the commercialisation of the test in the US thanks to an FDA approval.
- Contacts with KOLs and patients associations of various countries (France, USA, Germany, Italy, Spain, UK) have been strengthened thanks to METAFORA’s continuous involvement in various GLUT1DS related events and interactions during the scientific committee of the METAglut1TM study.
- A Global Medical Manager, based in Barcelona, has been hired in 2021 to work on the communication and dissemination of the test internationally.
- A multicentric clinic validation study, involving 33 centres in France and enrolling 625 patients, has been successfully completed with a positive outcome confirming the performance of the test (in accordance with the French health authorities’ requirements: HAS).
- In addition to the clinical validation study, a health economic study gathering economic evidence on the burden represented by the GLUT1DS affection on top of its medical burden is finalised with the help of CEMKA and will be submitted to the HAS by the end of 2021 in order to obtain the reimbursement of METAglut1TM in France.
- 2 other retrospective studies have been completed: in Germany (56 patients enrolled), where the cytometry platform has been installed and running at Heidelberg’s Children hospital, and in Italy (17 patients enrolled) at the Milan Children Hospital where the platform is planned to be installed, making the test available in these countries.
- A first very positive pre-submission meeting has been held with the FDA in November 2018 to discuss the submission of a de novo dossier in the USA. This will enable the commercialisation of the test in the US thanks to an FDA approval.
- Contacts with KOLs and patients associations of various countries (France, USA, Germany, Italy, Spain, UK) have been strengthened thanks to METAFORA’s continuous involvement in various GLUT1DS related events and interactions during the scientific committee of the METAglut1TM study.
- A Global Medical Manager, based in Barcelona, has been hired in 2021 to work on the communication and dissemination of the test internationally.
We are the only company in the world that has developed a diagnostic platform which can evaluate and quantify cell’s metabolism through the monitoring of nutrient transporters. This allows us to effectively and specifically diagnose Glut1DS sooner in children. At the same time, METAglut1TM will significantly reduce the cost of diagnosing Glut1DS.
METAglut1TM is a revolutionary test for users and practitioners, because it is:
• Non-invasive and painless.
• Simple, fast and automated.
• >99% specific.
• Affordable
The promise of the test is to drastically change the way children are diagnosed from this debilitating disorder, by helping to diagnose them timely to prevent intellectual disabilities to develop.
METAglut1TM is a revolutionary test for users and practitioners, because it is:
• Non-invasive and painless.
• Simple, fast and automated.
• >99% specific.
• Affordable
The promise of the test is to drastically change the way children are diagnosed from this debilitating disorder, by helping to diagnose them timely to prevent intellectual disabilities to develop.