Regulatory Compliance
The mission of Pangaea Oncology is to generate a new framework of therapeutic oncology based on personalized models, and incorporate this strategy into standard medical practice. To achieve this, the services we offer our clients are based on a commitment to comply with the quality, environmental and occupational health and safety (SSL) standards established by the laws, regulations and specifications which apply to our each area of our activities. We are also continuously working to improve the performance of our services through self-assessment and ongoing management review.
Pangaea Oncology was the first pharmacogenomics laboratory in Spain to be accredited, by the National Accreditation Body (ENAC), ISO 15189 Acreditation nº750 / LE15156 to perform genetic testing for cancer patients in liquid biopsy (serum/plasma) samples and tissue samples. In 2020 we got a new acredited tests such as in NGS into Liquid Biospy (first laboratory in Spain) and Tissue by using QIAGEN Clinical Insight (QCI) , and detection of rearrangements of the ALK, RET and ROS1 by gene hybridization and digital count of the relative abundance of mRNA transcripts by using N-COUNTER (NANOSTRING).
Receiving ENAC accreditation has enabled us to achieve the ILAC-MRA mark, an EU-wide designation which certifies that laboratories and inspection bodies in different countries work to uniform regulations.
We also participate in several External Quality Assessment (EQA) programs:
GENQA (Genomics Quality Assessment)
SEAP (Pathological Diagnosis and IHC)
ESP-EQA (European Society of Pathology)
ESP-LUNG EQA (ESP Lung External Quality Assessment Scheme)
UK-NEQAS (EGFR, KRAS, BRAF, NRAS and EML4-ALK)
Pangaea has also been positively audited by the Food and Drug Administration (FDA) as part of regulatory approval for Roche Diagnostics' Cobas® EGFR Mutation Test for non-small-cell lung cancer patients.
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