The laboratory of Solid Tumors and Hereditary Diseases of CIMA LAB Diagnostics renews and expands the accreditation ISO15189
The National Entity of accreditation (ENAC) has renewed the accreditation ISO 15189 of the laboratory for Solid Tumors and Hereditary Diseases of CIMA LAB Diagnostics and has extended the scope to internship its entire service portfolio.
Thus, laboratory offers new accredited tests and guarantees a higher quality service for patients. According to Dr. Gorka Alkorta, co-director of laboratory, "having the accreditation of our tests is essential to ensure that the decisions of clinical specialists are taken from agreement with reliable results, increasing diagnostic quality".
The new tests accredited at laboratory for Solid Tumors and Hereditary Diseases are:
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Identification of biomarkers with clinical validity in cancer. Mutations, copy changes and rearrangements in 500 genes by massive sequencing (NGS). Confirmation technique by dPCR.
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Identification of biomarkers with clinical validity in pediatric tumors, sarcomas and hematological malignancies. Mutations, copy changes and rearrangements in 200 genes with clinical value. Confirmation technique by dPCR.
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Identification of variants (SNVs, indels and CNVs) in germline (postnatal samples), in 179 genes associated with hereditary hearing loss. Nuclear and mitochondrial gene panel. Confirmation technique: sanger sequencing.
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Detection of hematopoietic chimerism by STRs analysis.
The accredited tests are in addition to those obtained since 2021 and, according to Maite Urdin, Quality Director of CIMA LAB Diagnostics, "they provide a differential value, as they increase the reliability of the results, achieve greater safety for the patient and improve the confidence of healthcare professionals".
