Accreditations
Prestige & Excellence
As a diagnostic tool, we offer a service that guarantees maximum technical competence in the crucial role of ensuring that clinical decisions are made based on reliable results, thus minimizing patient safety risks and increasing quality towards DIAGNOSTIC EXCELLENCE.
Laboratory Developed Tests (LDT) — Public Declaration (Art. 5.5 IVDR)
Pangaea Oncology S.A. declares that the following laboratory-developed tests are manufactured and used exclusively within our institution under Article 5.5 of Regulation (EU) 2017/746 (IVDR):
- EGFR (exons 19, 20, 21), BRAF (exon 15) and KRAS (exon 2) mutation detection by PNA-based allelic discrimination, in tissue and liquid biopsy. (Internally developed)
- Somatic alteration detection (SNVs, indels, CNVs) by NGS — 30-oncogene panel, in tissue and liquid biopsy. (RUO)
- ALK, RET, ROS1 rearrangements and MET exon 14 splicing variants by hybridisation-based digital quantification, in tissue and liquid biopsy. (RUO)
These tests are operated under ISO 15189 (ENAC accreditation no. 750/LE1556), comply with Annex I of the IVDR, and are justified by superior analytical sensitivity and compatibility with minimal sample input compared to available CE-IVD alternatives. Full justification is documented in the quality management system and available upon request.
Last reviewed: June 2024 — Carles Gannau, Quality Manager.
Pangaea Lab, the first accredited laboratory in Spain specialized in liquid biopsy applied to cancer treatment
Pangaea Lab expands its scope of accreditation in molecular studies of tumors
Pangaea Lab, the first accredited laboratory in Spain specialized in liquid biopsy applied to cancer treatment
Pangaea Lab expands its scope of accreditation in molecular studies of tumors