Regulatory Compliance

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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.

As a result, we are the first pharmacogenomics laboratory in Spain to be accredited, by the National Accreditation Body (ENAC), ISO 15189, to perform genetic testing for cancer patients in liquid biopsy (serum/plasma) samples (nº750 / LE15156 Annex 7). The laboratory is also accredited for analysis of EGFR mutations (exon 19, 20 (T790M) and 21), KRAS (exon 12-13) and BRAF (V600E) in tissue samples (see laboratory accreditation nº750 / LE15156 Annex 7).

Anexo Tec Rev 7 Alcance de la acreditación de 2016.

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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 the following Best Practice programs:

  • UK-NEQAS (EGFR, KRAS, BRAF, NRAS and EML4-ALK)

  • SEAP (Pathological Diagnosis and IHC)

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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