Laboratory of Molecular Diagnostics

1. Location, Opening Hours and Contact Information

The Laboratory of Molecular Diagnostics is an organisational unit of MultiplexDX, s.r.o., a legal entity duly established and existing under the laws of the Slovak Republic, established pursuant to Decision No. 61-50111965-A0001 as a facility providing comprehensive diagnostic and therapeutic services with a focus on medical genetics. The laboratory is located at Comenius University Science Park, Ilkovičova 6335/8, 841 04 Bratislava, Slovakia.

The laboratory aims for compliance with international standards of ISO 15189:2022 and is actively working towards accreditation by the Slovak National Accreditation Service (SNAS).

Administrative / contact hours	Monday to Friday, 10:00 – 16:00
Specimen acceptance hours	Monday to Friday, 08:00 – 15:00
General enquiries	+421 290 268 316 \| info@multiplexdx.com.
Examination orders / specimen receipt	diagnostics@multiplexdx.com.
Registered address	Ilkovičova 8, 841 04 Bratislava – Karlova Ves, Slovak Republic

2. Scope of Services

The laboratory provides advanced molecular diagnostic services focused on breast cancer, using the Multiplex8+ test to generate accurate and reliable results that support personalised treatment decision-making. For further information see: www.multiplex8.com.

Laboratory activities encompass pre-examination, examination, and post-examination processes. Core activities include:

fluorescent in-situ hybridization,
next-generation sequencing (NGS),

The laboratory does not collect primary samples from patients; primary collection and preparation of FFPE blocks are performed by designated institutions according to standard protocols and supplied by pathology laboratories as part of standard diagnostic care and prior to the material’s delivery to the laboratory.

The laboratory specifies the requirements that providers must meet.

3. How to Request Testing / Send Samples

Physicians may request testing by contacting the laboratory at diagnostics@multiplexdx.com to obtain the order form. The laboratory provides guidance and assistance throughout the ordering process to ensure proper submission and appropriate coordination of specimen transfer.

The order form is submitted by the physician together with patient informed consent and the specimen. The laboratory then processes the material and issues a tailored report based on the patient’s individual tumor profile.

The Multiplex8+ test is performed using an existing biopsy or surgical resection (FFPE block) obtained via standard-of-care diagnostics. No additional biopsy is required for testing.

Procedure in Case of Damage to the Shipment or Injury

The shipped material consists of tissue samples embedded in paraffin. The tissue is fixed with formalin, which inactivates any potential infectious agents. Therefore, there is no risk of infection transmission in the event of damage to the shipment or contact with the material, and the health risk is minimal.

If you come into contact with the material, simply wash the affected area with soap under running water and treat it with a commonly available disinfectant; the same applies if you sustain an injury while handling a damaged shipment.

Do not unpack the damaged shipment or repackage it into another container; contact us immediately by phone at +421 290 268 316 or by email at diagnostics@multiplexdx.com. Store the shipment in a safe place; we will inform you of the next steps.

For additional practical information, including sample reports, please refer to the Medical Professional section of the Multiplex8 website: www.multiplex8.com/medical-professional.

4. Key Pre-Analytical Requirements

Specimen type	Formalin-fixed, paraffin-embedded (FFPE) tissue block or FFPE tissue sections (minimum of 10 sections, each 5–10 µm thick) obtained from breast biopsy or surgical resection specimens.
Minimum specimen quantity	One tissue block containing at least 10% tumour tissue.
Fixation requirements	Specimens shall be fixed in 10% neutral buffered formalin for 6 to 72 hours.
Age of FFPE block	FFPE blocks up to 5 years from fixation are preferred. Older blocks may be accepted following prior consultation with the laboratory.
Specimen identification	Each specimen must be clearly labeled with the FFPE block identification number and must be accompanied by a properly completed order form.
Packaging for transport	FFPE blocks shall be placed in a rigid, leak-proof container (e.g. cardboard histology box) with protective padding. The outer packaging shall be clearly labelled with sender and recipient details.
Transport temperature	Specimens shall be transported at ambient temperature (15 to 30 °C). FFPE blocks must not be frozen or exposed to extreme temperatures during transport, as this may cause RNA degradation.
Accompanying documentation	Each specimen submission shall be accompanied by the completed order form, which includes patient informed consent, and relevant clinical information, such as diagnosis, previous treatment, and disease staging.
Logistics	Specimens may be sent by courier. Prior notification (submission of the order form) to the laboratory by e-mail (diagnostics@multiplexdx.com) before dispatch is recommended to allow preparation for receipt.

5. Specimen Acceptance and Rejection Criteria

Each received specimen is evaluated for acceptability upon receipt. Specimens that meet the pre-analytical requirements described in Section 4 are accepted. Specimens may be rejected if one or more of the following conditions apply:

specimen not accompanied by a completed and signed order form,
order form does not contain a signature for patient informed consent,
patient identification on specimen and order form cannot be unambiguously matched,
specimen type is not FFPE block,
fixative other than 10% neutral buffered formalin (e.g. Bouin’s solution, HOPE fixative),
evident degradation, autolysis, or extensive necrosis rendering examination impossible,
contamination or visible soiling of specimen,

In exceptional circumstances where a specimen does not fully meet acceptability criteria but is clinically critical or irreplaceable, the laboratory may elect to process it following risk assessment and written agreement with the requester. In such cases, the examination report will contain an explicit comment regarding the deviation and its potential impact on result interpretation.

In the event of specimen rejection, the requester is informed without undue delay, ordinarily within 1 working day of receipt, with the reason for rejection stated.

6. Examination Process, Costs and Turnaround Time

Price	EUR 2.980 per examination. Additional information regarding invoicing and payment terms is provided upon request or as specified in the applicable contractual documentation.
Standard turnaround time (TAT)	15-20 working days from receipt of a conforming specimen and complete accompanying documentation.
Urgent examinations	Urgent examination are not routinely performed and may only be considered upon prior individual agreement with the laboratory.
TAT extensions	TAT may be extended in cases of IQC failure requiring repetition, need to supplement clinical information, exceptional specimen acceptance, planned instrument downtime, or high-workload periods.
Result delivery	The diagnostic report is issued to the ordering physician as a PDF document, released electronically to the requester’s e-mail address. Delivery by post may be arranged upon prior agreement.
Consultation on results	Available by telephone or e-mail during administrative hours. Requests may be directed to diagnostics@multiplexdx.com.
Revised reports	If an amendment to an issued report is required (e.g. due to a clerical error, supplementary clinical information, or laboratory error), the laboratory issues a revised report clearly identified as such, stating the reason for the revision. The requester is notified without undue delay. All previous versions are archived.

Sample reports are publicly available on the Multiplex8 website: www.multiplex8.com/medical-professional.

All results are treated as confidential and are disclosed exclusively to authorised persons in compliance with applicable data protection legislation, including the GDPR and Act No. 18/2018 Coll.

7. Factors Affecting Examination Performance and Interpretation of Results

Pre-analytical, clinical, and technical factors may affect the performance of the examination and/or the interpretation of results. Requesters are required to provide all relevant information in the request form so that such factors can be appropriately taken into account during evaluation and interpretation.

These factors include:

prolonged or insufficient fixation (>48 hours or <6 hours),
use of a fixative other than 10% neutral buffered formalin,
advanced age of the FFPE block (>5 years),
low tumour cell content,
previous neoadjuvant or systemic treatment,
decalcification using strong acids,
necrotic or autolytic tissue,
intratumoral heterogeneity,
prior IHC or FISH examinations performed on the block, potentially resulting in tissue exhaustion,
contamination of the specimen with foreign tissue.

8. Complaints Process

The laboratory has documented procedures for the management of complaints and other forms of feedback submitted by physicians, patients, laboratory personnel, or other parties. A complaint is defined as any negative submission concerning the laboratory’s activities in relation to examinations or inappropriate conduct of laboratory personnel.

Complaints, suggestions, and comments shall be submitted in writing by e-mail (in Slovak or English) to: diagnostics@multiplexdx.com.

A complaint should include:

identification of the complainant (name, institution) and contact details,
a description of the subject of the complaint, including identification of the specific case (laboratory ID, date of specimen receipt, date of report issuance), where relevant,
supporting documents or evidence relevant to the assessment of the complaint,
the expected resolution, if any.

Acknowledgement	Within 5 working days of receipt
Resolution	Ordinarily within 30 calendar days of receipt

The laboratory does not take discriminatory action against any complainant.

All complaints are recorded, analysed for systemic trends and reviewed at management review meetings as input for continual improvement.

11. Quality Policy and Management Commitment

MultiplexDX Laboratory of Molecular Diagnostics is committed to providing high-quality, impartial, and clinically reliable molecular diagnostic services in accordance with the requirements of ISO 15189:2022 and applicable legislation.

The laboratory has appointed a Quality Manager who is granted independence from operational activities and holds responsibility for maintaining and improving the quality management system. The Quality Manager reports directly to laboratory management on the performance of the QMS and any need for improvement.

The full Quality Policy is available upon request from the laboratory.