SomArray Breast

If you have been diagnosed with breast cancer (diagnosis based on histology), you are likely to be eligible for molecular profiling of the cancer. This molecular test aims to detect whether the tumor has mutations in the BRCA1, BRCA2 genes, as well as other genes closely associated with breast cancer.

According to reports from the NCCN (National Comprehensive Cancer Network), breast cancer carrying mutations in the BRCA1 & BRCA2 genes is a candidate for treatment with PARPi, or PARP inhibitors.

The main indications for the SomArray Breast test are:

1. Triple-negative breast cancer [previously tested for hormone receptor expression (estrogen-ER, progesterone-PR), & HER2, using the Immunohistochemistry (IHC) method on a cancer sample embedded in a paraffin cube that came out negative for all three biomarkers].
2. Metastatic breast cancer, HER2-negative (IHC)

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:

• Your sample is processed once (and not repeatedly), by experienced tissue technologists, after its adequacy is immediately checked by the Pathologist,
• Material is obtained sequentially in such a way as to ensure diagnosis, perform Immunohistochemistry & molecular tests.
• Delicate enrichment manipulations are followed to ensure the maximum possible amount of cancer cells, which could affect the validity of the results, a task performed by Pathologists.
• The molecular biologist immediately processes the sample in a fully controlled environment, with next-generation sequencing ( NGS ) or real-time polymerase chain reaction ( Real-time PCR ) to identify mutations in the genes of interest, or with the immunohistochemistry ( IHC ) method on a certified platform, to check the expression of tumor proteins.

Breast cancer is both a local and a systemic disease, that is, a disease that can affect various parts of the body. In the treatment of breast cancer, the oncological goals are twofold:

1. Eradicating the disease from the breast
2. Eradicating the disease from the body

The first goal is achieved with surgery and radiation.

The second goal is achieved with systemic treatment, that is, with medications.

The initial treatment is usually surgery , which also establishes the definitive diagnosis of cancer with histological examination .

The aim of surgical treatment is to remove the entire tumor.

Correct and complete initial surgery is of great importance for the further progression of the disease and must be performed by a specialist mammologist, specialized in breast surgery.

Next, TNM staging is necessary [determination of tumor size ( T ), detection of metastasis in lymph nodes ( N ) and detection of distant metastases in other organs ( M ), which is determined during the Histological Examination. Based on the latter, clinical staging will be performed.

Examination to determine if the tumor expresses Hormonal Receptors (Oestrogen, Progesterone), the HER2 biomarker and the Ki67 cell proliferation marker . This is done using the Immunohistochemistry method on the Histological Examination material. The result will determine the treatment choice by the Oncologist.

The choice of treatment is determined by the following parameters:

• The histological examination
• TNM staging
• The result of the test for whether the tumor expresses the hormones ER, PR and the biomarker HER2
• If the tumor carries mutations in the BRCA1 & BRCA2 genes

Consult your Oncologist to personalize your treatment, after diagnosis and/or surgical removal of the tumor.

If you have been diagnosed with breast cancer (diagnosis based on histology), you are likely to be eligible for molecular profiling of the cancer. This molecular test aims to detect whether the tumor has mutations in the BRCA1, BRCA2 genes, as well as other genes closely associated with breast cancer.

According to reports from the NCCN (National Comprehensive Cancer Network), breast cancer carrying mutations in the BRCA1 & BRCA2 genes is a candidate for treatment with PARPi, or PARP inhibitors.

The main indications for the SomArray Breast test are:

1. Triple-negative breast cancer [previously tested for hormone receptor expression (estrogen-ER, progesterone-PR), & HER2, using the Immunohistochemistry (IHC) method on a cancer sample embedded in a paraffin cube that came out negative for all three biomarkers].
2. Metastatic breast cancer, HER2-negative (IHC)

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

Contact us at 2310 23 22 72 and we will immediately assist you in quickly transporting the sample to our laboratory.

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.