ARCEDI BIOTECH ApS

Egen beskrivelse på virk.dk

ARCEDI is an advanced diagnostics company and a first mover in cell-based non-invasive prenatal testing (cb-NIPT). The Company has developed and commercialized EVITA TEST COMPLETE®, the world’s first clinically validated cell-based NIPT solution, enabling true fetal genotyping from gestational week 10 through isolation and analysis of intact fetal cells from maternal blood. EVITA TEST COMPLETE® provides diagnostic-level genomic insight non-invasively and addresses a significant unmet need in prenatal care. Approximately 2.2% of pregnancies are affected by serious genetic diseases, many of which remain undetected prenatally using conventional cell-free NIPT (cf-NIPT) and current screening protocols. This represents a substantial unmet need for improved prenatal screening both in Denmark and internationally. ARCEDI’s technology enables genome-wide detection of aneuploidies, high-resolution detection of pathogenic copy number variations (pCNVs), and detection of selected monogenic diseases through an ISO 15189–accredited and scalable laboratory workflow. In 2025, ARCEDI continued commercial operations in Denmark through private clinics in the out-of-pocket market. Future growth is expected to be driven by enhanced product differentiation through improved analytical resolution and accelerated international expansion. During 2025, the Company completed development work that significantly enhanced test performance: • Genome-wide detection of pathogenic copy number variations (pCNVs) down to 1 Mb and detection down to 0.4 Mb for 20 selected DECIPHER-listed syndromes (deletions/duplications), accredited under ISO 15189. • Expansion into monogenic disease testing with cystic fibrosis, also accredited under ISO 15189. Additional monogenic panels are under development. In collaboration with Aarhus University Hospital and Aarhus University, ARCEDI received approval for the GENIUS project funded by Innovation Fund Denmark. The project includes funding for 1,000 cb-NIPT tests and aims to generate clinical and health economic documentation to support broader adoption of advanced prenatal screening. The GENIUS project will commence in Q1 2026.Internationally, 2025 was primarily focused on validation, partnership dialogue and strategic positioning. • First international distribution agreement was signed. • Dialogue continued with selected IVF and international diagnostics partners, including preparation for pilot activities and validation studies. • Outreach and dialogue with potential strategic partners and investors for international expansion progressed across several regions. No revenue related to these international initiatives has been recognized in the 2025 financial statements.