Accredited Medical Services
In MicroDiagnostics Ltd, from the receipt of the sample, the establishment of diagnosis, up to the completion of the molecular profile of the disease, the procedure is governed by the principles of Quality Assurance, in conducting all individual examinations according to the ISO: 15189 accreditation model for clinical tests.
based on valid histological and cytological examination. The primary purpose of the diagnosis is to determine if the disease is benign, malignant, and to identify its name since based on the histological diagnosis the prognosis and the choice of further treatment are determined (surgery, pharmaceutical approach, radiation, or a combination thereof).
based on detailed pathological staging and accredited biomarkers. Histological examination contains important information that is crucial for the prognosis such as:
- the expression of immunohistochemical biomarkers (e.g. PD-L1, HER2, etc.)
- the extent to which the tumor (T) spreads to the affected organ
- if there is metastasis to lymph nodes and in how many numerically (N)
- if there are distant metastases in other organs (M)
- if there are affected vessels, lymphatic vessels or nerves
- if the tumor’s surgical excision margins are free of disease
based on algorithmic evaluation of the phenotype, protein expression, and genotype. The histological examination determines the phenotype. Protein expression corresponds to immunohistochemical biomarkers. The genotype corresponds to the molecular profile of the tumor.
- The molecular profile of the tumor highlights the possible presence of gene mutations
- We are mainly interested in gene mutations of clinical significance (pathogenic mutations)
The combination of the above helps to determine the individualization of the patient’s profile
targeted treatment choices based on molecular pathology tests. The revealing of the molecular profile of the tumor (genotype) in combination with the results of immunohistochemical biomarkers and histological examination will help the oncologist to personalize the patient’s profile.
- for the selection of the optimal treatment
- evaluation of the response to treatment
- the detection of recurrence of the disease
Quality Control general information
- is fully tracked at all stages of processing within the microDiagnostics’ Ltd laboratory
- is registered with a unique number and a barcode
At each stage of the procession, the available material results during the performance of multiple examinations, the performer of each procedure (secretariat, histologist, pathologist, molecular biologist) are recorded in detail under the status of each medical test.
It concerns the control of all Procedures, Work Instructions, and Exam Protocols, administrative and laboratory operations, and that all are met as they have been established and defined.
It concerns the control by observing the Procedure for carrying out a specific test, from the receipt of the sample in the laboratory, until the final approval and reporting of the diagnosis
It concerns the re-evaluation of the case, subsequently, by the same pathologist or cytologist who made the initial diagnosis.
It concerns the reassessment of the findings, by a different pathologist or cytologist, from the one who made the initial diagnosis.
It concerns the reassessment of the results at a later stage, by a different pathologist or cytologist, apart from microDiagnostics’ Ltd team
External Quality Assessment
The accredited tests are subjected to external assessment by European bodies (LABQUALITY, ESP, UKNEQAS, NORDIQC) on a regular annual basis, a process which ensures consistent results of high quality