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Promoting effective diagnosis and personalised cancer treatment

CIMA LAB Diagnostics of the University has been accredited by ENAC (Entidad Nacional de accreditation) in three of its genetic diagnostic tests.

FotoManuelCastells/Team of the laboratory Solid Tumours and Hereditary Diseases of CIMA LAB Diagnostics of the University of Navarra.

01 | 12 | 2021

To offer an effective and accurate diagnosis in order to be able to apply personalised cancer treatments. This is one of the main objectives of the tests carried out at CIMA LAB Diagnostics on the basis of genetic panels. CIMA LAB Diagnostics has been accredited by ENAC (Entidad Nacional de accreditation), with accreditation nº 1263/LE2634 for the rule UNE-EN ISO 15189 in three of its genetic diagnostic tests based on Next Generation Sequencing (NGS) technology: Identification of biomarkers with clinical validity in liquid biopsy, which analyses mutations in 52 genes; identification of biomarkers with clinical validity in solid tumours, with mutations, copy changes and rearrangements in 161 genes and identification of alterations in 91 genes that predispose to different types of hereditary cancer. 

The test liquid biopsy of 52 genes is used to study the nucleic acids of the tumour that circulate freely in the blood. Liquid biopsy allows samples to be taken when there is no tumour or it is too risky for the patient to access it, in order to proceed with personalised treatment. Moreover, due to the sensitivity of the techniques used, it allows early detection of the disease, its progression or relapse.

The study of biomarkers in solid tumours (tissues) in adults analyses 161 genes, offering a very complete result for their diagnostic, prognostic and predictive value for response or as criteria for inclusion in clinical trials. The panel is a very useful tool for the molecular characterisation of synchronous tumours and to establish whether they are related (primary tumour or metastasis). According to Dr. Ana Patiño, co-director of laboratory of Solid Tumours and Hereditary Diseases at CIMA LAB Diagnostics, "performing this panel with a high number of genes issue allows the study of genes frequently altered in cancer and the possibility of exploring others that will probably have targeted therapies in the essay clinical phase, expanding the patient's treatment options".

On the other hand, those tests based on the analysis of hereditary factors seek a personalised diagnosis based on the study of 91 genes, which make it possible to obtain the complete sequence of genes related to cancers with a hereditary component: colorectal, gastric, pancreatic, renal and urinary tract, thyroid, breast and ovarian, melanoma, paraganglioma/pheochromocytoma.

The accreditation includes all the requirements that clinical laboratories responsible for analysing biological samples of human origin must comply with to ensure that the laboratory has a quality management system in place, that it is technically competent and has the capacity to produce technically valid results. "Although in Spain, the implementation of this rule is not mandatory, the laboratory opted for the accreditation as it guarantees the technical skill in all the processes of the laboratory in each of its phases: pre-analytical, analytical and post-analytical. At all times, it is possible to know and evaluate the correct functioning of the laboratory and always offer a service with the maximum guarantee of quality," says Maite Urdin, quality manager of CIMA LAB Diagnostics.

With this accreditation CIMA LAB Diagnostics becomes a benchmark of quality in the clinical field for these tests. According to Dr. Gorka Alkorta-Aranburu, co-director of laboratory of Solid Tumours and Hereditary Diseases of CIMA LAB Diagnostics, it provides a differential value: "The accreditation of our services by an external agent such as ENAC, supports the concept that the results delivered have been generated with the maximum technical skill , at the level of staff, equipment and facilities, under the strictest quality controls and with the aim of generating reliable clinical information," he concludes.