Development and validation of the first digital, clinical grade flow cytometry platform for enhanced diagnosis accuracy and sustainability in immunology and hemato oncology

Introduction

After successful development of METAglut1, an IVD Medical Device for diagnosis of the Glut1 Deficiency Syndrome (available for clinical use), we are currently focused on developing a new breakthrough solution: METAflow.

Background

Flow cytometry (FC) is a powerful tool widely used in research. However, the high cost and complexity of interpretation of FC data hampers its full clinical exploitation.

Pain Points

Main pain points of clinical FC data analysis include:

1. Need for manual analysis, which is accompanied by complexity with increasing number of dimensions.
2. Lack of robustness.
3. Limited scale-up.

Challenges

The lack of an automated analytical process stems from:

• Dearth of robust algorithms.
• Limited regulatory compliance.
• Need for considerable coding skills.

Solution

With METAflow, we bring to the market the first digital, clinical-grade FC platform, which offers comprehensive data analysis, robustness, and usability, addressing the “lost in translational research” issue of flow cytometry in the clinics.