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Integrated Laboratory

The Reason Why Us Quality Features AccuracyResponsibility Always on target Full Tracking

"... genomic analysis in the absence of histopathological assessment
risks creating vague results"

A valuable histopathological examination for both the clinician and the patient includes a diagnostic algorithm that incorporates conventional histopathology with immunohistochemistry and molecular tests related to the disease.

The reason we offer trustworthy pathology services

It is a matter of Quality & Management

– patients deserve the best we can offer them – successful patient management starts with precision medicine, while individualized medicine requires reliable molecular tests of individual utility

– pioneers in the diagnosis & translational genomics

– because we combine morphology (phenotype) with genotype

– combining the image of the tumor, with the expression of the protein, with its molecular identity

– within the same laboratory, a team of pathologists, molecular biologists, histotechnologists

– because we avoid unnecessary time delays

– because we strategically manage the patient’s biosample at all stages within our laboratory

– we know, because we produce the block, we guarantee proper enrichment, excellent macroscopy, reliable molecular signature

– we guarantee controlled storage conditions

– we provide an integrated pathology report and a unified archive of samples-genetic material

Unique Quality Features

01

High level automated workflow

02

Laboratory Information System (AP-LIS) with full tracking & traceability:
• Barcode marking (elimination of mismatch identification problems)
• Macrophotography
• Microphotography

03

Production of paraffin block, diagnosis, prognostic & predictive tests within the laboratory

04

One-Touch approach (avoidance of tissue waste)

05

Possibility of reflex testing
(reduction of response time)

06

External Quality Assessment (EQA)
ISO 15189 accreditation

Learn more about the Quality & Strategic Management Procedures, and the advantages of microDiagnostics Ltd

In the integrated laboratory of microDiagnostics Ltd:

01The pathologist decides on the method of tumor’s fixation before DNA extraction according to the instructions of CAP/NCCN
03The pathologist is responsible for the selection and the evaluation of the paraffin blocks of the tumor. The pathologist determines whether there is a sufficient amount and quality of the tumor to be used for DNA extraction. Note that he or she is the one who has already evaluated and interpreted the tumor, has produced more than one paraffin block and has thoroughly examined it under a microscope in the form of stained sections. The quality and quantity of the primary material, with which Real-Time PCR or NGS techniques will run, has significant/decisive effects on the sensitivity and accuracy of the result.
05The pathologist along with the molecular biologist, participate actively in the laboratory process for all oncological molecular tests. Data are analyzed and discussed jointly by the pathologist and the molecular biologist.
07The response time is significantly reduced after the completion of the whole procedure in the pathology laboratory that provided the histopathological diagnosis.
02The pathologist identifies the appropriate source of tumor specimen for gene mutation testing. There are cases where molecular gene profiling can be performed in the archival material of the primary tumor, despite the presence of metastasis, thus the need for a repeat biopsy is avoided. Especially if chemo-radiation therapy has been preceded.
04The pathologist is responsible for enriching the tumor cells in a targeted tissue sample. To increase the sensitivity of the detection of a mutation, we use methods to enrich the test sample with techniques that require the user to be familiar with microscopy and histopathology.
06The pathologist incorporates the results of a molecular test in the histopathological report, recording important information (sample adequacy, how the enrichment was done, which paraffin block was selected)
08MicroDiagnostics Ltd maintains in its facilities a fully controlled archive for the preservation and protection of genetic material (paraffin blocks, blood, cytological fluid) in appropriate storage conditions, as required in each case).
The integration of molecular diagnostics in the routine of the pathology laboratory means that the sample does not need to be transferred outside the department.
This feature has a direct impact on the patient as:
01There are no unnecessary delays associated with the need for samples or paraffin blocks to be sent away, something that is against the patient’s interest.
02In microDiagnostics Ltd, the molecular biologists performing a test are familiar with the latest clinical data related to the molecular changes examined and the complications of histopathological, clinical, and therapeutic specific molecular tests, through close and direct contact with the group.
03In microDiagnostics Ltd the responsibility for the final diagnosis is clear and unambiguous 
04The Pathologist has the role of the messenger of the information between the molecular biologist and the clinician, ensuring the right test, in the right patient, at the most appropriate time.
A histopathological diagnosis (histological examination) is based

– in the microscopic analysis of the tissue with the usage of additional special techniques; (e.g. histochemical, immunohistochemical and molecular tests) and

– in clinical data,

in order to provide information on the histological type of the tumor and report the prognostic & predictive data, with an immediate impact on targeted treatments selection
Quality Control

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 medical tests, according to the ISO: 15189 model for clinical trials.

TRACEABILITY

Each sample:

  • is fully tracked at all stages of processing within the microDiagnostics’ Ltd laboratory
  • is registered with a unique number and a barcode

Each step of the process, the available results during the performance of multiple tests, the performer of each procedure (secretariat, histologist, pathologist, molecular biologist) are recorded in detail under the status of each case.

QUALITY ASSURANCE

In MicroDiagnostics Ltd, the quality assurance of all the tests offered is achieved by performing regular internal checks.

They concern the vertical inspection where the application of the Quality System in a specific test is checked and includes the whole process that is applied, and the horizontal inspection where the implementation of the Procedures/Instructions that have been established is inspected.

The quality assurance team also organizes the reassessment of the already completed cases by the medical team in order to control the required Repeatability & Reproducibility of results.

All accredited tests are subject to procedural controls by European entities (LABQUALITY, ESP, UKNEQAS) on a systematic, annual basis, a procedure that ensures results of a high Quality.

Frequently Asked Questions (FAQ)

Can all ordered tests be performed on my sample?

Most of the times, the sample material we are called to handle, is minimum because it has resulted from a minimally invasive method (needle biopsy, fluid puncture, FANB, EBUS, e.t.c.).

In our laboratory, pathologists check if the material is sufficient. If so, then a management algorithm follows, in order to:

to perform multiple tests on the material (Immunohistochemistry, real-time PCR, NGS) to fully highlight the molecular profile of your tumor (proteins, genes, histological Grading)

What is the management algorithm followed in my sample?

At our Integrated Pathology Laboratory, we handle your sample in such a way as to minimize unnecessary waste:

  • Your sample is being processed once (and not repeatedly) by experienced histotechnologists, after its adequacy is checked by the Pathologist.
  • Tissue sections are obtained successively in such a way as to ensure interpretations diagnosis, and performance of immunohistochemistry & molecular tests, where necessary.
  • Careful handling and enrichment to ensure the maximum possible number of cancer cells is present, which could affect the validity of the results, a work performed by pathologists.
  • The molecular biologist immediately processes the sample in a fully controlled environment, using next-generation sequencing (NGS) or real-time PCR to detect mutations in the genes of interest, or by the method of immunohistochemistry (IHC) on a certified platform to detect & evaluate tumor protein expression.

What happens if my sample is not adequate?

In this case and if the enrichment manipulations of the sample have been ceased, we contact your clinical doctor to discuss alternative approaches in order to extract the desired information for the optimal treatment for you. Some examples:

Perform an alternative test (e.g. Immunohistochemistry instead of PCR, or Next Generation Sequencing – NGS)

Implementation of Immunohistochemistry instead of FISH (Fluorescent In Situ Hybridization)

Possible blood sampling instead of tissue testing (liquid biopsy)

Possibility of a new biopsy or puncture (FNAB, EBUS, e.t.c.)

Who interpretes & evaluates my results?

The processing of your sample is done by experienced Histotechnologists and Pathologists.

Molecular tests are performed by Molecular Biologists.

The results of all tests (immunohistochemistry, molecular biomarkers, cytogenetics) are evaluated and interpreted by Pathologists in order to compile and integrate the final Findings

Pathologists and Molecular Biologists regularly participate on a weekly basis in a Multidisciplinary Tumor Board (MTD), where all the medical specialties involved combine their findings, aiming at the best treatment decision for you.

How do you ensure that my exams have clinical value and utility?

Through constant contact and communication with your treating physicians (Oncologist, Surgeon, Interventional Radiologist, Radiotherapist, etc.) and within the framework of Multidisciplinary Meetings, to select or decide the following:

the available sample,

histological diagnosis,

cytological diagnosis,

overall health,

the prognostic & predictive profile of the disease

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