THE LEADER IN LABORATORY DIAGNOSTICS€¦ · Head of professional medical supervision until the present day. In cooperation with her colleagues and under her leadership, this department

THE LEADER IN LABORATORYDIAGNOSTICS

THE LEADER IN LABORATORYDIAGNOSTICS

COMPREHENSIVE LABORATORY DIAGNOSTICS



INVISIBLE FOR THE PATIENT, INDISPENSABLE FOR THE PHYSICIAN Your partner in comprehensive laboratory diagnostics

MEDIREX GROUP: A complex range of diagnostic laboratories under one roof

Clinical biochemistry

Hematology

Clinical immunology

Medical genetics

Molecular biology

Serology

Virology

Bacteriology

Mycology

Parasitology

Cytology

Biopsy/histology

QUALITY COMES FIRST

RNDr. Elena TIBENSKÁ,

PhD., Medical Director,

Medirex

QUALITY COMES FIRST Quality managementsystem

MEDIREX GROUP laboratories (Medirex a.s., Medicyt, s.r.o.) are accredited as fully conforming to ISO 15189, the international standard for quality and competence of medical laboratories.

System for information security management

MEDIREX GROUP laboratories are certified as fully conforming to the ISO 27001 international standard.

Quality managementsystem

MEDIREX GROUP laboratories are certified as fully conforming to the ISO 9001:2015 international standard.

PROFESSIONAL QUALITY SUPERVISION

She is a graduate of the Faculty of Natural Sciences of Comenius University in Bratislava in the subject of Molecular Biology and Genetics. In 1997, she graduated a specialization course in laboratory methods in clinical immunology. In 2004, she graduated a certification program titled ‘Health Management and Public Health’ organized under the auspices of the University of Scranton and in 2006 she completed her doctoral course. She has worked in the field of immunology since 1994, starting at the Department of Clinical Immunology of the Children Teaching Hospital in Bratislava, where she participated in several

research projects as an investigator. In 2006, she founded the Department of Clinical Immunology in Medirex, where she has worked as the Head of professional medical supervision until the present day. In cooperation with her colleagues and under her leadership, this department has ranked among the largest and most advanced laboratories in this particular field in Slovakia. In her professional practice, Dr. Tibenská mainly specializes in flow-based cytometry as well as testing of auto-antibodies, allergies and developing of diagnostic approaches in reproductive immunology. She regularly gives lectures at domestic and foreign conferences and congresses,

QUALITY COMES FIRST

MUDr. Peter VEREŠ,

Medical Director, Medicyt

PROFESSIONAL QUALITY SUPERVISION

After graduating in General Medicine at the Medical Faculty of Comenius University in Bratislava, he passed the 1st and 2nd degree board certification to become a consultant and specialist consultant in pathology. He started his professional clinical practice as a physician-pathologist at the Pathology Department of the Hospital with Polyclinic in the town of Galanta, later working at the Department of Pathology of the Faculty Hospital in Trnava. In 1993, Dr. Vereš returned to the Pathology Department of the Hospital with Polyclinics in Galanta as the Head and remained working at this position for 11 years. In 2004 – 2008 he worked as a physician-pathologist at the Pathology Department of the Teaching Hospital in Trnava.

cooperates with the Medical Faculty of Comenius University on research projects and acts as the primary adviser in diploma and bachelor theses at Faculty of Natural Sciences of Comenius University in Bratislava and Faculty of Pharmaceutics of Comenius University in Bratislava.

“In Medirex laboratories, we pay maximum attention to quality. All our laboratories are accredited in conformity to international standards. Besides ensuring leading quality in analytics, we put much stress on the procedures in the pre-analytical stage which we regard as a highly important part of laboratory diagnostics.”

In 2008, he became the Head of professional medical supervision in Medicyt. Together with multiple colleagues in his team, they gradually built one of the largest pathology laboratories in Slovakia, annually evaluating more than 300,000 cytological preparations and almost 100,000 biopsies. In 2010, Dr. Vereš became the professional supervisor in implementation of LBC (liquid-based cytology), the new cytological method introduced in Slovakia. Medicyt is the only laboratory in Slovakia having used computer-assisted analysis of cytology specimen in cytological diagnosis since 2014. MUDr. Peter Vereš actively participates in various scientific and research studies, intensely contributing to improvements in diagnosis of cervical cancer.At the moment, he is also a member of the Pathology Committee of the Slovak Medical Society and the Vice-Chairman of the Section of Clinical Cytology of the Clinical Cytology Section of the Pathology Society of the Slovak Medical Society.

“It is exactly the exceptional workflow organisation of our labs that ensures the high quality that we consistently deliver.”

SUPPORTING SCIENCE AND BIOMEDICAL RESEARCH



WE IMPLEMENT NEW TYPES OF LABORATORY TESTING IN CLINICAL PRACTICE We cooperate on development of new tests with a wide range of scientific, academic as well as private scientific and research institutions.

We support Slovak science and research

TRISOMY TEST

A non-invasive screening test from maternal blood delivering a high level of precision in testing for and ruling out the presence of frequent chromosomal disorders of the fetus starting from the 11th week of pregnancy;

Detects the risk of trisomy of chromosomes 21 (Down syndrome), 13 (Patau syndrome), 18 (Edwards syndrome), aneuploidy of X and Y sex chromosomes (e.g. Turner and Klinefelter syndrome) and selected microdeletion syndromes (1p36, Cri-du-Chat, DiGeorge, Prader/Willi and Angelman syndrome);

Predicts fetal sex;

Detects false positive results of biochemical prenatal screening thus reducing the number of amniocenteses to a minimum;

Does not pose any risk to the mother or the baby;

We are among the laboratories that perform this test internationally;

Quick delivery of test results - as early as 5 working days after receiving the sample.


CE LABEL

EPO-PATENTED:

Trisomy test SW (software) has obtained the EC CERTIFICATION confirming that the in vitro diagnostic medical product is manufactured in conformity to all the quality requirements defined in the Council Directive 98/79/EC, Annex II and can therefore be labelled with the CE marking.

The computing software used for the non-invasive prenatal TRISOMY test has obtained the CE IVD certification.

The computing analysis used in our own proprietary TRISOMY test is highly innovative and introduced new processes in the assessment of diagnostic method. Based on its innovative character, the method was granted with an EPO (European Patent Office) patent No. EP 3283647;

The innovative NIPT software is based on a principle of random reading of maternal and fetal genomic DNA both present in the blood plasma of the mother. After launching of the software tool, a bioinformatic analysis is performed over the data, delivering the test result.


TECHTRANSFER We offer the possibility of techtransfer-based

cooperation to our potential laboratory partners;

Implementation possible only regarding the tests developed in Slovakia: Trisomy test/Trisomy test XY, Trisomy test+, BabyGen;

We implement the laboratory-based part of the methodology directly in the partnering lab;

Collection of samples, primary processing of samples, analysis, test assessment, distribution of the results – all the respective stages of the test are implemented and performed by the partner in their own laboratory;

The computing part of the test is performed in our laboratories; the method is subject to the protection of proprietary know-how and is protected by the EPO-granted patent No. EP3283647.


Please check with your

gynaecologist


Find your baby’s sex quickly and reliably

BABYGEN Genetic test enabling determination of fetal sex

from maternal blood starting as early as from the 10th week of pregnancy.

from 10th week*

early

in 5 working days*

fast

with 99,5 % accuracy

reliable

from mother’s blood

simple

* In accordance with the Ministry of Health of the Slovak Republic Ethics Committee’s resolution, the laboratory can provide information about the fetal sex only after the end of the 12th week of the pregnancy.


RNDr. Gabriel Minárik,

PhD.

He graduated from the Department of Molecular Biology, Faculty of Natural Sciences, Comenius University in Bratislava in 2000, where he also completed his doctoral studies in 2005. He has authored or co-authored more than 75 publications indexed in the Current Contents, with over 340 citations. Between 2001 and 2007, he worked as a specialist in conventional sequencing within the scope of the BITCET program. He

was among the first professionals in Slovakia in this field and is still one of the most experienced Slovak experts in this particular method of sequencing. Currently, he mainly does research in the field of analysis of biological samples, with application in non-invasive prenatal and cancer DNA diagnostic staking advantage of massive parallel sequencing, while paying particular attention to applied research, mainly within the scope of TRISOMY test.

“Implementing this type of laboratory test into routine clinical practice is a very demanding process considering the local conditions, moreover, if we realise that the test is a result of our own scientific research. It makes me proud all the more that after three years in the market, our proprietary TRISOMY test is the best-selling NIPT test in Slovakia and that it has even found its stable clients abroad.”

AUTHORS OF THE METHODOLOGY The test has been developed by leading Slovak scientists; Molecular biologists RNDr. Gabriel Minárik, PhD.

and RNDr. Tomáš Szemes, PhD.


RNDr. Tomáš

Szemes, PhD.

He graduated in biology from the Faculty of Natural Sciences of Comenius University in Bratislava and completed his doctoral study in 2010. Today, he is an author of multiple renown professional publications. Already during his yeas as an undergraduate biology student, he had an ambition to apply the new scientific knowledge into practice. Since 2010 he has worked as the Head of Genomics and Bioinformatics Laboratory originally at the faculty of Natural Sciences, later moved to the new Scientific Park of Comenius University. Dr. Szemes specialises in analysis and interpretation of DNA sequences.

He is also active as a pedagogue at the Faculty of Natural Sciences of Comenius University. In 2006, together with his colleagues, he founded Geneton, a company that has been active particularly in the field of research and development of methods in non-invasive prenatal diagnostics since 2007. With his team, Dr. Szemes developed a method for determination of fetal chromosomal disorders from a sample of maternal blood, which is currently used in clinical practice. He is a co-author of 3 European patent claims, which are at the priority stage and 1 which has been granted a patent.

“Since Trisomy test delivers a higher degree of sensitivity compared to conventional screening methodology, it provides an improved rate of certainty also to the pregnant women who didn’t fall into the risky category.”

Molecular biologists RNDr. Gabriel Minárik, PhD. and RNDr. Tomáš Szemes, PhD.

THE MOST ADVANCED TECHNOLOGY IN EUROPE



THE LARGEST AND MOST DIVERSE TECHNOLOGICAL SOLUTION IN LABORATORY AUTOMATION IN CENTRAL AND EASTERN EUROPE Leader in process automation

Reduces the turn-around time: the time from receipt of the sample in the lab until delivery of the final results to the healthcare provider or the patient;

A single tube enables testing of a much higher number of parameters across the whole portfolio of laboratory diagnostics;

If necessary, the line can automatically generate secondary tubes: sample of serum for the needs of manual testing methods which may be performed in parallel;

Substitutes manual procedures, which may be a potential source of diagnostic errors;

Minimises manual handling of the samples thus reducing the potential risk posed to the medical staff in the laboratory:

automated sample centrifugation,

automated opening and closing of the tubes before storage in the cooling boxes,

automated distribution of samples to the respective analysers by way of the conveyor belt,

automated storage of samples and their disposal free of manual handling with the capacity of as much as 15,000 samples per box (we operate 3 boxes).

In case the testing needs to be repeated or another test parameter needs to be added, the sample is automatically transported from the cooling module to the conveyor belt, the protective film from the tube is removed and the sample is transported to the selected analyser unit to perform the desired test;

It delivers a higher degree of automation in pre-analytical, analytical and post-analytical activities in the lab thus reducing the need for manual handling by the laboratory staff, increasing the standardisation of the respective laboratory processes and reducing the rate of errors in the lab operations.

AUTOMATED APTIO LAB LINE:



The length of the Aptio line conveyor belt reaches as many as 80 meters;

The line combines several manufacturers of diagnostic technology and equipment such as Siemens, Roche, Phadia, Biorad, Sysmex, Diasorin;

It comprises 25 analysers; 21 auxiliary and servicing items (entry and exit modules, input modules for stands, centrifuges, cap removal mechanisms, tube closing mechanisms, units for secondary cap removal, aliquoting unit, DMS server, compressor, cooled storage module);

An important advantage of this new solution is its versatility: if necessary, it can be rebuilt and extended which enables a higher degree of flexibility in diagnostics as well as further increase in the capacity of processed samples;

Analysers from various manufacturers may be added to the line;

If necessary, the new automated line may move samples even across the respective floors of our building.

INTERESTING TECHNICAL FEATURES OF THE AUTOMATED LINE:

STATE-OF-THE-ART TECHNOLOGY IN OUR LABS


GC-MS, LC-MS – a method that combines gas or liquid chromatography with mass spectroscopy

It is used in toxicology as a confirmation test for identification of drugs, in diagnosing of the level of medicines and trace elements in the organism.

HPLC – high-performance liquid chromatography

Enables identification and determination of the concentration of substances that are present in the sample in trace amounts;

This methodology determines several highly sensitive parameters: glycated haemoglobin, D vitamin, C vitamin, catecholamines and their metabolites in plasma and urine, free metanephrines in urine, serotonin and 5-IHAA, its metabolite as well as porphyrins and levels of some medicinal drugs in organism.

AAS – atomic absorption spectroscopy

Enables establishing of concentration of trace elements in biological liquids as well as tissues;

This method is applied e.g. to determine the concentration of copper and zinc in serum and urine.

Infra red spectroscopy

Enables a precise analysis of composition of urinary concrements.

CLINICAL BIOCHEMISTRY


NGS (Next generation sequencing) diagnostics

NGS sequencing in diagnostics of hereditary and oncological diseases:

NGS is currently gradually replacing the conventional procedures in molecular biology in detection of causal genomic changes in patients with hereditary and oncological diseases;

Key advantages brought by the NGS approach is the ability to analyse multiple genes simultaneously, which results in reduction in the time necessary for analysing of the samples and lower costs of analysis;

It is not only an important tool in diagnostics of genetically determined diseases but also in their potential screening, prognostics, or forecasting of therapeutic response with respect to personal genetic information, i.e. one of the important tools in personalised medicine.

NGS sequencing in prenatal diagnostics (TRISOMY):

Non-invasive prenatal testing (NIPT) represents a significant advance in prenatal screening as such;

The applied methodology is based in whole genome sequencing and enables identification of chromosomal aberrations at the whole genome level;

When identifying pregnancies with a high risk of monitored chromosomal aberrations, we apply our own proprietary and highly unique know-how developed in Slovakia.

GENETICS



ArrayCGH (comparative genome hybridisation)

Array CGH is a chip-based technology;

It offers an innovative process in detection of imbalanced rearrangements (deletions/duplications) in the patient’s genome with location that is unknown in advance;

The method delivers a 100-times higher level of sensitivity compared to karyotyping and therefore advances cytogenetic diagnostics to the molecular level.

CGH is a solution delivering a high-definition detection of sub-microscopic changes in the genome;

it is often applied in prenatal and postnatal diagnosis;

contributes to better specification of diagnosis, in prevention, prognosis, search for better treatment and provides diagnostic information for prenatal genetic counselling;

can also be applied in cases when culture tests fail (amniocytes etc.);

provides a solution in case of unclear findings using other PCR methods (NGS, QF-PCR, MLPA).

GENETICS

WHAT MAKES US STAND OUT



COMPREHENSIVE APPROACH TO DIAGNOSTICS OF IMMUNOPATHOLOGICAL DISEASES

A modern approach to diagnostics– a SINGLE drop of blood enables testing of a wider range of parameters;

applied in diagnostics of multiple diseases such as:

autoimmunity diseases – determining autoantigens specific for systemic autoimmunity diseases, systemic sclerosis, autoimmunity myopathies, nervous system diseases;

allergic diseases – determining 20 and more native allergens from a single drop of blood;

establishing of protein allergen components – the individual components of allergens – using the biochip methodology – determination of over 100 components from a single drop of blood – this test enables the physician to determine with precision

to which allergen composition the patient is allergic, which enables him or her e.g. to set-up a better diet;

comprehensive diagnostics of food reactions

diagnostics of conventional allergic reactions – determining of specific IgE antibodies (over 400 native allergens and allergen components), functional basophile testing;

diagnostics of non-IgE food reactions (over 300 allergens);

diagnostics of histamine intolerance;

comprehensive diagnostics of celiac disease, besides determination of antibodies (serology diagnosis) also genetic diagnostics (identification of HLA antigens associated with celiac disease).

MULTIPLEX METHODOLOGIES

We provide comprehensive laboratory approach to the issue of reproductive disorders caused by immunity system; within this diagnostic framework, we test for autoimmunity diseases, antiphospholipid syndrome, celiac disease as well as the cell immunity parameters with the focus on intracellular cytokines and NK cell activity.

REPRODUCTIVE IMMUNOLOGY:

INNOVATION FOR FASTER AND MORE PRECISE RESULTS


PREVENTION OF CERVICAL CANCER

Besides the basic cytological screening, a single sample collection enables performing also an HPV test, immunohistochemical testing for Ki67/p16, sexually transmitted diseases (Chlamydia trachomatis, Neisseria gonorrhoeae, urogenital mycoplasmas, ureaplasma and Trichomonas vaginalis);

PC-assisted microscopy: works 24/7 and increases the chance of detection of cellular changes that could escape the human eye;

Using a special cell-illumination method (densitometry), the device screens as many as 50,000 cells on every glass slide and will identify the 22 most suspicious areas that are later assessed and reviewed by the cytologist;

The reliable test result thus undergoes dual control – first by the automatic microscope and then also by a physician specialised in cytology.

LBC (LIQUID-BASED CYTOLOGY)

1. HPV DNA 2. HPV mRNA 3. HPV genotype

POSSIBILITIES OFFERED BY HPV TESTS


Detection of viral DNA – screening test

A temporary infection which is supressed by the immunity system in 80% of cases

Critical points in HPV DNA testing:

HPV DNA test may be positive, but this does not mean a carcinoma will develop

HPV DNA test – does not provide differentiation between a temporary and persistent infection

HPV DNA

Detection of E6 and E7 gene expression (detection of presence of a multiplying integrated virus) – an active form of viral infection

Expression of E6/E7 mRNA is essential in progression of cervical carcinogenesis

An integrated HR-HPV virus impacts the cell cycle which may result in malign transformation

HPV mRNA

Detection of presence of a specific type of HPV genotype

Presence of minimum residual infection following an ablative intervention on the cervix

Presence of HR-HPV 16 and 18 as well as LR-HPV 6 and 11 before planned vaccination

HPV GENOTYPE

MOST ADVANCED LABORATORIES



WE OPERATE THE MOST ADVANCED AND LARGEST LABORATORIES IN CENTRAL AND EASTERN EUROPE 3 central laboratories in Bratislava, Košice and Nitra

We provide testing for multiple departments of lower-degree local hospitals across Slovakia;

We cooperate with more than 3,500 private clinics and specialised medical offices all over Slovakia;

We examine samples from more than 25,000 patients every day, resulting in approximately 250,000 tests and analyses daily;

We provide final diagnosis, for some diagnostic methods we perform, we are the only provider in the Slovak Republic;

In the field of genetics, we provide diagnostic services also to foreign partners.

We provide our services for the largest hospitals in Slovakia:

University Hospital in Bratislava;

L. Pasteur University Hospital in Košice;

Children Teaching Hospital in Košice;

East Slovakian Institute of Oncology in Košice;

Brothers Hospitallers’ University Hospital with Polyclinics in Bratislava;

J. A. Reimann Teaching Hospital with Polyclinic in Prešov;

National Institute of Children’s Diseases in Bratislava.

LEADERSHIP IN DIGITALISATION OF LABORATORY DIAGNOSTICS IN SLOVAKIA


PROCESS OF ELECTRONIC PROCESSING

OF EXAMINATIONS

7. Delivery of the results in

paper form

DELIVERING OF RESULTS BY OUR DRIVERS

4. Blood and other biological material is attached to the printed

electronic application form

MATERIAL COLLECTION

3. Application form to be sent

is completed and printed at AIS

ELECTRONIC APPLICATION

FORM5. Entering the sample in the

laboratory, coupling the sample with the

application form is faster

EXAMINATION IN THE LAB

6. After validation of the result by laboratory

staff the results are immediately

accessible to the physician (department’s

system/client zone)

ELECTRONIC STORAGE

OF RESULTS2. Blood or

other biological material is taken

in the outpatient’s department

SAMPLING

1. PHYSICIAN, NURSE

OUTPATIENT’S DEPARTMENT


LEADERSHIP IN DIGITALISATION OF LABORATORY DIAGNOSTICS IN SLOVAKIAOn the path to digitalisation of healthcare

We introduced LOINC in Slovakia, the international standardised system of codes in laboratory methods;

We are participating in implementing the eHealth concept in the Slovak Republic;

We are implementing direct online communication with our clients and ensure online transfer of results to the patient documentation;

Our clients can also use the so-called ‘client zone’ offering access to the full database of indicated tests and examinations with the corresponding results as well as full history of results of their individual patients.

Electronic apps – work as a functional link between hospital information systems and our laboratory information system

We are implementing the ‘Môj labák’ app for patients

It will provide patients with overview of the results of standard tests online including their full history.

‘MÔJ LABÁK’ (MY LAB) APP

WE SUPPORT RESEARCH AND EDUCATION


EDUCATIONAL AND PUBLISHING ACTIVITIES OF OUR EXPERTS

The objective of the journal is to establish a strong link between applied research and practice;

With two issues per year, the magazine provides space for professional science and research articles written by our colleagues as well as other authors from the academia;

The journal publishes the latest from science and research as well as clinical practice;

Newslab is indexed in Bibliographia Medica Slovaca.

NEWSLAB – professional peer-reviewed journal of laboratory medicine

We cooperate with prestigious Slovak universities: - Comenius University in Bratislava; - Pavol Jozef Šafárik University in Košice.

We educate undergraduate students of medicine and natural sciences in healthcare subjects;

We organise doctoral studies and post-graduate education of physicians and other healthcare professionals;

We provide education to laboratory staff, laboratory analysts and physicians;

We organise international and national conferences, seminars and other professional events.

EDUCATIONAL ACTIVITIES


č. 13/jún 2018

V čom je unikátna nová automatická linka v centrálnom

laboratóriu?

Aké sú výhody elektronických žiadaniek?

Objednajte si odberový materiál do svojej ambulancie

jednoducho online

Najnovšie zmeny v klasifi kácii enkapsulovaných folikulárnych

tumorov štítnej žľazy

MXG_07431_labMED_JUN_2018_press.indd 1 04/06/2018 12:10

Reflecting on the latest news in laboratory medicine in Slovakia, globally as well as in MEDIREX GROUP;

The target group are physicians of all specialities – clients of MEDIREX GROUP laboratories to whom the journal is distributed directly together with results;

labMED informs the readers on legislation changes, brings the latest information on new methods and trends in laboratory medicine which influence their daily work helping the patient;

The journal also offers space for presentation of results of science and research activity.

labMED – professional journal of laboratory medicine

MARKET LEADER

MARKET LEADER

MARKET LEADER

We have been active in the laboratory diagnostic market for 18 years;

We hold the largest market share in Slovakia, reaching 35.9 %;

2017 turnovers amounted to €63m; thanks to cooperation with our foreign partners, we grow over 5% every year;

We operate 3 central labs in Bratislava, Košice and Nitra

The central laboratory in Bratislava is the largest one in Central and Easter Europe with floor area covering almost 7,000 m2;

We employ over 800 highly qualified professionals;

We perform over 4,000 types of tests;

Every day, we analyse samples from over 30,000 patients;

We issue 200,000 to 250,000 test results to patients on a daily basis;

We can be testing as many as 4,800 genes simultaneously;

We test for more than 500 allergens, while over 100 simultaneously;

Using multiplex PCR, we analyse as many as 21 respiratory pathogenic microorganisms in 1 hour in a single run;

We are able to identify as many as 300 microorganisms in 1 hour (MALDITOF).

MEDIREX GROUP

MARKET LEADER

OUR INVESTMENTS ABROAD

A modern network of diagnostic laboratories, it ranks among the largest providers of laboratory diagnostics in the Czech Republic;

Its comprehensive range of services is ensured by the respective departments of the central labs – immunology, serology, clinical biochemistry and microbiology, haematology, toxicology, medical genetics as well as the instrumental methods department;

Central laboratories: Prague, Brno and Ostrava

A special LCMS laboratory (liquid chromatography with MS detection) used for determining the level of antiepileptic drugs, benzodiazepine, antipsychotics, homocysteine, methylmalonic acid, plasma and urine methanephrines, steroid hormones and ethyl glucuronides;

Development of new methods and innovative processes.

Our subsidiary in the Czech Republic: SPADIA LAB, a.s.

www.laboratornadiagnostika.sk

Medicyt, s.r.o.Galvaniho 17/C, P.O. Box 145820 16 Bratislava, Slovak Republic

Medirex, a. s.Galvaniho 17/C, P.O. Box 143820 16 Bratislava, Slovak Republic

Documents

THE LEADER IN LABORATORY DIAGNOSTICS€¦ · Head of professional medical supervision until the present day. In cooperation with her colleagues and under her leadership, this department