UrinArray Basic & Broad

Bladder cancer is associated with various biomarkers that can be used for diagnosis, prognosis and/or treatment monitoring. Typical examples:

FGFR (Fibroblast Growth Factor Receptor) – frequent mutations, especially in non-invasive tumors. Targeted therapies exist (e.g. erdafitinib).

PIK3CA – involved in the PI3K/AKT/mTOR pathway.

TP53 – associated with response to platinum chemotherapy.

TMB (Tumor Mutational Burden) – predictive biomarker for immunotherapy with checkpoint inhibitors.

PD-L1 – expression is associated with response to immunotherapy (e.g. pembrolizumab, atezolizumab).

NTRK fusions (TRK fusions: NTRK1, NTRK2, NTRK3) can also be detected in bladder cancer, although they are rare (frequency <1%). They constitute a targetable biomarker regardless of the histological type of the tumor. There are already approved drugs for NTRK-fusion positive tumors, such as larotrectinib, entrectinib.

Nectin-4 – its overexpression is an indication for administration of the targeted therapy enfortumab vedotin.

The tests are performed on the surgical specimen (paraffin cubes) or the biopsy material (paraffin cube) from which your histological examination was performed or on the aspiration material (FNAB, EBUS) from which your cytological examination was performed. In our fully integrated Laboratory, the pathologist selects the most appropriate & representative paraffin cube, ensuring that the most appropriate sample will be used for the tests. Qualitative and quantitative parameters are checked.

In case your sample is not already at Microdiagnostics archive, please contact us immediately so that we can arrange for its safe and rapid transport to our laboratory. You will also need to quickly and easily complete the Consent Form.

In our fully integrated Laboratory, we handle your sample in such a way as to minimize its unnecessary waste:

• The paraffin cube is placed, if possible, once on the microtome for obtaining tissue sections, by experienced tissue technologists.
• Tissue sections are obtained sequentially in such a way as to ensure diagnosis and perform Immunohistochemistry if required.
• Ensuring preservation of tissue sections for further molecular testing.
• Pathologists perform microdissection to ensure the maximum amount of cancer cells possible, removing all other necrotic cells or normal tissue that could affect the validity of the results.
• The molecular biologist immediately processes the tissue in a fully controlled environment, using next-generation sequencing (NGS) or real-time polymerase chain reaction (Real-time PCR) to identify mutations in the genes of interest.

The number and type of mutations tested is updated through a dynamic process in accordance with current scientific research. It should therefore be recognized that there is a possibility that the list of genes on the order form may have changed (genes added or removed) during the analysis of the sample in the laboratory.

Molecular testing for bladder cancer is particularly useful in the following areas:

Treatment personalization – Allows the identification of targetable gene alterations (e.g. FGFR, NTRK), so that the patient can receive personalized treatments with greater effectiveness and fewer side effects.

Prognosis and response prediction – Molecular markers such as mutations in TP53 or PD-L1 expression help to assess which patients will respond best to chemotherapy or immunotherapy.

Participation in clinical trials – Molecular testing opens the door to experimental but promising treatments for patients with advanced disease.

In short, molecular testing is the “key” to the application of personalized medicine in bladder cancer, improving both the outcome and the quality of life of patients.

The tests are performed on the surgical specimen (paraffin cubes) or the biopsy material (paraffin cube) from which your histological examination was performed or on the aspiration material (FNAB, EBUS) from which your cytological examination was performed. In our fully integrated Laboratory, the pathologist selects the most appropriate & representative paraffin cube, ensuring that the most appropriate sample will be used for the tests. Qualitative and quantitative parameters are checked.

In case your sample is not already at Microdiagnostics archive, please contact us immediately so that we can arrange for its safe and rapid transport to our laboratory. You will also need to quickly and easily complete the Consent Form.

Most of the time, the sample material we are called upon to handle is small because it has resulted from a minimally invasive method (needle biopsy, fluid aspiration, paraffin block with minimal material).

In our laboratory, Pathologists check in a timely manner whether the material to be examined is sufficient. If so, then a management algorithm is followed, with the aim of achieving the performance of multiple tests on the material (Immunohistochemistry, real-time PCR, NGS) in order to fully check the molecular profile of your tumor (proteins, genes, histological Grading).

In this case, and once sample enrichment manipulations have been exhausted, we contact your clinician to discuss alternative approaches in order to obtain the desired information to select the optimal treatment for you. Some examples:

• Performing an alternative test (e.g. Immunohistochemistry instead of PCR, or choosing Next Generation Sequencing (NGS))
• Performing Immunohistochemistry instead of FISH (Fluorescent In Situ Hybridization) and tubulin
• Possible blood sampling instead of tissue testing (liquid biopsy)
• Possible option to take a new biopsy or puncture

Our team will undertake the quick and safe transport of the sample to our laboratory, please inform us at tel. 2310 232 272.

By cash, bank card, bank deposit, or Online interbank deposit.

One of the primary concerns at Microdiagnostics is the protection of your personal data as well as the strict observance of the conditions for the protection of your genetic material and medical results.

In full compliance with the General Data Protection Regulation (GDPR), we ensure that any test conducted is done with your knowledge and consent and we do not communicate results over the phone.