SOMA Genomics
Budget
€10 — €0
EP Access
0
accredited persons
Staff
1
0.1 FTE
EU Grants
None
Mission & Goals
SOMA Genomics AB develops scientifically rigorous, clinically usable companion diagnostics (CDx) for targeted oncology therapies. Our remit is to advance EU policy that enables drug–diagnostic co-development, strengthens evidence generation (analytical + clinical utility), and improves patient access to safe, effective precision treatments. We contribute constructively to MDR/IVDR implementation, EU HTA alignment, and responsible innovation in diagnostics—supporting accuracy, reproducibility, and value-based care across Member States.
EU Legislative Interests
Medical devices and in vitro diagnostics – targeted revision of EU rules. Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). EU HTA Regulation (EU) 2021/2282.
Communication Activities
Position notes to EU services and stakeholders on integrated drug–CDx pathways, briefing decks shared during public consultations/roundtables, and participation in workshops on predictable NB timelines, proportionality for low/medium-risk diagnostics, and joint evidence generation in oncology.
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
Karolinska Institute Science Park
Additional Information
Our up-to-date estimate of annual costs relating to activities covered by the Register is currently 0€. The financial figures cover a full year of operations and refer to the most recent financial year closed. They include staff costs, office expenditure and any other expenses related to interest representation activities for that period.
Commissioner Meetings
No recorded meetings with EU commissioners.