Report
Teaser, summary, work performed and final results
Periodic Reporting for period 1 - METAdiag (Detecting serious diseases due to abnormal cellular energetics)
Teaser
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...
Summary
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 nutrient transporters at the cell’s surface.
Cutting edge algorithms using Artificial Intelligence to handle big data participate in generating actionable results to physicians for 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. Encouraging results of a pilot study have been published in a leading scientific journal, has been CE-marked and is at the basis of a partnering agreement with CERBA Healthcare, a leading Medical Testing Laboratory.
We are in prime position to achieve go-to-market status by 2020. The only missing ingredients are the upscaling and prospective validation of METAglut1TM, which are the objectives of our project. We have already developed METAglut1TM to TRL 6, as well as defined the value chain. After phase 2, our time to market for METAglut1TM will be less than 1 year.
After 5 years of commercialization, we expect sales of 1.68 million tests, at an end-user price of 300 € per test, including analysis and report. By 2021, we will reach breakeven with a net profit of 840.276 €. By the end of our 5-year commercialization phase, we will have generated 52 M€ in cumulated revenues with a ROI of 2.7.
Work performed
We have achieved significant work and milestones on the METAglut1TM clinical validation study:
- Protocol study finalised in accordance with the French health authorities’ requirements (HAS and ANSM).
- A team of experienced professionals has been gathered to prepare and monitor the study: project manager, clinical research assistant, external clinical research assistant, quality manager, R&D technician.
- 31 centres have been enrolled, opened and trained on the study (on a revised targeted total of 40);
- First patients have been enrolled in October 2018 (at the study’s start) and recruitment is increasing along the way.
- A cytometry platform has been installed at Heidelberg’s Children hospital in Germany for a local retrospective clinical study that will help to make the test available in Germany.
- 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 involvement in various GLUT1DS related events.
Final results
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 reduce the cost of diagnosing GLUT1DS by 75%.
METAglut1TM will be a revolutionary test for users and practitioners, because it is:
• Non-invasive and painless.
• Simple, fast and automated.
• 100% 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.
Website & more info
More info: https://www.metafora-biosystems.com/en/metaglut1/.