Atrys obtains the ISO 15189 accreditation
April 12, 2013
ENAC, the Spanish National Accreditation Entity has granted accreditation to Althia Health, S.L. (Althia) in recognition of the quality and technical competence in accordance with the criteria set out in the UNE-ENISO 15189: 2007 standard for conducting tests on Pathology and Molecular Pathology.
Althia is the first laboratory in Spain to be accredited according to the UNE-EN ISO 15189 standard in immunohistochemistry (IHC) and in fluorescent in situ hybridization (FISH). The scope of such accreditation is for the determination of HER2 protein overexpression by immunohistochemical analysis and amplification of the HER2 gene by FISH in breast cancer tissue.
The UNE-EN ISO 15189 accreditation ensures Althia's technical and management competence as a laboratory or technical entity.
With this accreditation, Althia confirms its commitment to the highest levels of quality both in diagnostic services and in research collaborations, as well as in the field of clinical trials. The goal of Althia is to continue working to extend the scope of the accreditation obtained.
HER2 is a membrane receptor with tyrosine kinase activity, overexpressed or amplified in 15-25% of patients. In breast cancer patients it can be determined by immunohistochemistry (IHC), analyzing the expression of protein; and by fluorescence in situ hybridization (FISH), assessing its degree of gene amplification.
HER2 expression has been associated with a worse prognosis of the disease, some resistance to tamoxifen, and a greater sensitivity to anthracyclines against CMF. But its main value to date is its prediction of response to anti-HER2 therapy (trastuzumab or lapatinib).
HER2 expression and / or amplification should be determined in all breast cancer patients at diagnosis of the disease in order to consider the administration of adjuvant anti-HER2 therapy with trastuzumab. If the patient has metastatic disease and HER2 has not been previously determined, it must be established in the metastasis, or in the primary tumor if it is not possible to biopsy the metastasis.
Approximately 20% of HER-2 determinations may be incorrect. For this reason, a panel of experts from the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) recommends that local laboratories to be adequately accredited. When HER2 is determined by a validated test, there are no differences between IHC and FISH as predictors of the benefit of anti-HER2 therapy.