FoundationOne — tumour profiling

After a cancer diagnosis, an important question is whether the tumour's molecular features could help inform further treatment. FoundationOne provides comprehensive genomic profiling: analysis of hundreds of genes and selected biomarkers that may give the oncologist additional information about potential treatment options.

Tartaczna 2 Medical Centre in Gdańsk offers FoundationOne CDx, FoundationOne Liquid CDx and FoundationOne Heme. We welcome enquiries from patients across Poland. Please contact us before travelling to agree the next steps, the required clinical records and arrangements for tissue delivery or blood collection.

Call +48 58 719 10 25 to ask reception how to start the eligibility assessment.

Testing with consultations and a discussion of the results

The price includes consultations within the service and a report discussion with Dr Magdalena E. Korożan. The service includes:

• Clinical record review by Dr Magdalena E. Korożan as part of an oncology consultation.
• Selection of a test appropriate to the diagnosis and available sample.
• Help obtaining tissue when needed, and blood collection for Liquid CDx at our centre.
• Discussion of the report in the context of the patient's cancer; subsequent treatment decisions remain with the treating oncologist.

FoundationOne testing — prices in Gdańsk

• FoundationOne CDx — PLN 9800.
• FoundationOne Liquid CDx — PLN 9800.
• FoundationOne Heme — PLN 10,700.
• Optional additional PD-L1 testing — PLN 900.

FoundationOne test prices include consultations within the service and a discussion of the results with Dr Magdalena E. Korożan. PD-L1 testing is charged separately and ordered when clinically indicated.

Who may benefit from tumour genomic profiling?

Testing may be considered for patients with an established cancer diagnosis when the findings could help guide further management, including targeted therapy, immunotherapy or clinical trial participation. Dr Magdalena E. Korożan assesses the indications for testing during an oncology consultation, taking account of the cancer type, previous findings and treatment history. The patient arranges the date for blood collection or tissue delivery with reception.

Testing uses next-generation sequencing (NGS) to analyse many genes at the same time. It examines selected regions of the genome and biomarkers: biological features of the tumour that may help inform treatment choices. It does not sequence the whole genome.

These are not screening tests for detecting cancer in healthy people and do not replace a histopathological diagnosis. The oncologist determines how profiling fits into the existing diagnostic work-up and which other tests are needed.

FoundationOne CDx — solid tumour tissue testing

FoundationOne CDx analyses DNA across 324 cancer-related genes. The sample is formalin-fixed, paraffin-embedded tumour tissue or appropriately prepared unstained slides.

For FoundationOne CDx, if slides are supplied instead of a paraffin block, 11 unstained slides are required. Please confirm the sample preparation requirements with our centre in advance.

The test detects different classes of genomic alterations and assesses biomarkers including tumour mutational burden (TMB), microsatellite instability (MSI) and HRDsig, a signature associated with impaired DNA repair by homologous recombination. Their clinical relevance depends on the tumour type and treatment under consideration.

FoundationOne Liquid CDx — testing from a blood sample

FoundationOne Liquid CDx is designed for profiling solid tumours. It analyses 324 genes using cell-free DNA in plasma, including circulating tumour DNA (ctDNA). Peripheral blood is collected into special tubes.

This liquid biopsy may be considered when tissue is unavailable or insufficient, or in selected circumstances to complement molecular assessment. Reported biomarkers may include blood tumour mutational burden (bTMB), a measure of mutation burden assessed using DNA from blood, and high microsatellite instability (MSI-H).

A result showing no alterations does not rule them out: there may be too little ctDNA in the blood for detection. The doctor may recommend tissue testing. Liquid biopsy does not replace tissue testing in every situation.

FoundationOne Heme — DNA and RNA analysis for sarcomas and leukaemias

FoundationOne Heme is used for genomic profiling of sarcomas and leukaemias. It analyses DNA across 406 genes and RNA from 265 genes. RNA analysis helps detect gene fusions, which are abnormal joins between parts of different genes. For sarcomas, appropriately prepared tumour tissue from a paraffin block or slides is used. For leukaemias, the sample may be peripheral blood or a bone marrow aspirate. The sample type and collection arrangements must be agreed with our centre and the laboratory in advance.

The report includes detected alterations and biomarkers such as TMB and MSI. It can support further molecular assessment and management planning, but must be interpreted alongside other diagnostic tests and the clinical findings, including the results of haematological investigations in leukaemias.

What does the report contain?

• Detected genomic alterations, their interpretation and the biomarkers applicable to the selected test.
• Information about targeted therapies and immunotherapy linked to the detected alterations, and potentially relevant clinical trials. The report may list both medicines used for the patient’s cancer type and therapies approved for other indications.
• Scientific evidence supporting interpretation and the limitations of testing; variants of uncertain significance (VUS) may also be listed.

Testing may not identify an alteration for which a suitable treatment is available. Even if a medicine is listed, this does not mean it will be effective, accessible or reimbursed in Poland for the individual patient. Clinical trial participation requires meeting the trial’s eligibility criteria. The treating oncologist assesses these options in the context of the full clinical record. A variant of uncertain significance (VUS) alone is not a basis for choosing treatment.

Samples, testing process and turnaround time

1. An oncology consultation with Dr Magdalena E. Korożan, including review of the clinical records and assessment of the indications for testing, taking account of the diagnosis and previous molecular tests.
2. Selection of the test, confirmation of costs and sample requirements, and completion of the necessary documents.
3. The patient brings the tissue sample to Tartaczna 2 Medical Centre. We help obtain the material when needed. Blood for FoundationOne Liquid CDx is collected at our centre. The sample is prepared for transfer according to laboratory requirements.
4. The report is provided to the patient and discussed with Dr Magdalena E. Korożan — in person or by telephone if the patient prefers not to travel to the centre. The treating oncologist makes subsequent treatment decisions.

These are send-out tests. According to information from Roche, samples are sent to a laboratory in Penzberg, Germany. Indicative report turnaround times are approximately 14 working days for CDx and Liquid CDx and approximately 20 working days for Heme. The expected timeframe and when it starts are confirmed when ordering. Preparing documentation and transporting the sample may extend the total time from the initial enquiry to receiving the results. If the sample does not meet laboratory requirements, additional material may be needed.

Does this test assess inherited cancer risk?

Tumour profiling has a different purpose from inherited cancer predisposition testing. A variant detected in tumour material is not necessarily inherited. In selected cases, separate testing for inherited (germline) changes and genetic counselling may be recommended. Read about inherited cancer predisposition.

Optional PD-L1 testing

PD-L1 testing assesses expression of this protein in tissue using immunohistochemistry (IHC). It is a separate test, rather than analysis of an additional gene in the panel. It may complement biomarker assessment when considering immunotherapy. Roche offers it as an add-on to FoundationOne CDx and Heme; at our centre it costs an additional PLN 900. The doctor determines whether it is clinically appropriate.

PD-L1 is not tested using the blood collected for FoundationOne Liquid CDx. If it is needed for a patient undergoing Liquid CDx, suitable tissue must be provided and the laboratory must confirm that a separate order can be accepted.

How should I prepare my records and sample?

Have your histopathology report, details of previous treatment and any previous molecular test results available. During the assessment, we will establish whether further documents are needed.

Material from an earlier biopsy or operation can often be used for tissue testing. Its suitability is determined by laboratory assessment; a new sampling procedure is not always necessary. Contact us before requesting the paraffin block or slides from the pathology department — we can help obtain the material when needed. Blood collection for Liquid CDx requires an agreed appointment and the appropriate collection kit.

Contact and sample arrangements

To arrange a consultation, delivery of tissue or blood collection, contact reception on +48 58 719 10 25 or at kontakt@tartaczna2.pl. Please agree the required material and documentation with us before bringing a paraffin block or slides.

Explore our oncology consultations and other genetic tests.