Pathology Laboratory - The pathological examination is crucial for an accurate diagnosis and the possible formulation or modification of the treatment of patients.
Genekor’s pathology laboratory guarantees high-quality services for the accurate diagnosis, prognosis and treatment of patients. With years of experience and qualified staff, we will provide reliable and valid results that support the best possible care for your patients.
(as prognostic and/or predictive markers) carried out at the Genekor Pathology Laboratory
| EXAMINATION | TYPE OF CANCER |
|---|---|
| FRα (FOLR1) Ventana ® FOLR1 (FOLR1-2.1) RxDx Assay Method | ovarian cancer |
| Claudin 18.2 | gastric cancer |
| MMR | endometrial/colon cancer |
| p53 | endometrial cancer |
| ER/PR/HER2 (clone 4B5) /Ki-67 | breast cancer |
| HER2 (clone 4B5) | various types of cancer |
| DISH (Dual in situ hybridization) for HER2 2+ | |
| ALK | lung cancer |
| PD-L1 | various types of cancer |
In the new prime DX® test, the following predictive immunohistochemical markers can be added
| PD-L1 |
| HER2 overexpression |
| FRα for ovarian cancer |
| Claudin 18.2 for gastric and gastroesophageal junction adenocarcinoma |
| Cancer Type | IHC Panel | TAT |
|---|---|---|
| Gastric Cancer Panel | HER2 IHC, MMR IHC, Claudin 18.2 IHC, PD-L1 IHC | 3 working days |
| Ovarian Cancer | FOLR-1 IHC & HER2 IHC | 3 working days |
| Panels for Endometrial Cancer | ||
| A. | Pole exons 9-14 by NGS, MMR by IHC, P53 by IHC, (HER2 If needed) | 10 working days |
| B. | Pole exons 9-14 by NGS, MMR by IHC, P53 by IHC, L1CAM IHC, (HER2 if needed) IHC | 10 working days |
The FRα test is performed for the administration of mirvetuximab soravtansine and is aimed at patients with platinum-resistant ovarian cancer who are FRα-positive and have received 1-3 lines of therapy.
On September 19, 2024, the EMA issued a positive opinion for the administration of mirvetuximab soravtansine to patients with FRα-positive, platinum-resistant ovarian cancer who have received 1-3 lines of therapy, based on the phase III MIRASOL study.
In the US mirvetuximab soravtansine is FDA approved since March 2024.
The determination of FOLR1 (FRα) is performed immunohistochemically on biopsy material, surgical preparations or tissue encapsulated in paraffin-embedded cubes using the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. The anti-FOLR1 monoclonal antibody, FOLR1-2.1 clone is used on the Ventana BenchMark Ultra automated platform.
In clinical practice, the sample is considered FOLR1 (FRα) positive if the neoplastic cells show moderate (2+) to intense (3+) complete or incomplete membrane staining in 75% or more of the sample. The sample is acceptable if it contains at least one hundred viable cancer cells. A positive external control is used.
Claudin 18.2 (CLDN 18.2) test is used to determine eligibility for the administration of Zolbetuximab alongside chemotherapy in patients with advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.
The EMA on September 20 approved Zolbetuximab for patients with HER2 negative/Claudin18.2 positive advanced or metastatic gastric adenocarcinoma and gastroesophageal junction as first-line therapy along with chemotherapy based on the phase III GLOW and SPOTLIGHT studies. In the US, Zolbetuximab recently received FDA approval (18 October 2024). Additionally, new studies on Claudin 18.2-positive patients with advanced or metastatic gastric and gastroesophageal junction adenocarcinoma were presented at this year’s ESMO (ESMO POSTERS1,2,3)
The Claudin 18.2 biomarker also serves as a prognostic marker in pancreatic cancer. At ESMO, the design of phase II randomized GLEAM study was presented, examining the administration of Zolbetuximab alongside chemotherapy in patients with pancreatic cancer. In this study, 27.7% of patients showed Claudin 18.2 positivity (≥ 75%).
Claudin 18.2 is determined immunohistochemically on biopsy material, surgical specimens, or tissues embedded in paraffin blocks for stomach and gastroesophageal junction adenocarcinomas. The automated Ventana BenchMark Ultra platform is used.
According to recent studies, moderate (2+) to strong (3+) complete or incomplete membrane immunohistochemical expression in neoplastic cells, with a percentage of at least 75%, is considered positive expression. An external positive control is used.
Immunohistochemical analysis of mismatch repair (MMR) protein expression is conducted using the monoclonal antibodies VENTANA anti-MLH1 (M1), anti-PMS2 (A16-4), anti-MSH2 (G219-1129), and anti-MSH6 (SP93) on the fully automated VENTANA BenchMark ULTRA platform.
Evaluation of MLH1, PMS2, MSH2, and MSH6 expression provides insight into the functional integrity of the MMR system. Retained nuclear expression of all four proteins indicates a proficient MMR system (pMMR), whereas loss of nuclear expression in one or more proteins signifies mismatch repair deficiency (dMMR).
Detection of dMMR, contingent on tumor type and the specific pattern of protein loss, may suggest Lynch syndrome and warrant additional molecular or genetic assessment. Furthermore, dMMR serves as a significant predictive biomarker for potential immunotherapy, depending on tumor type, disease stage, and current therapeutic guidelines.
Assessment of MMR protein expression is determined by the presence or absence of nuclear staining in neoplastic cells.
Assessment of Estrogen and Progesterone Receptors, Ki-67 Proliferation Index, and HER2 Oncoprotein (Clone 4B5)
Immunohistochemical evaluation of key prognostic and predictive biomarkers is essential for determining therapeutic strategies in breast carcinoma, both in neoadjuvant and adjuvant settings.
Expression of estrogen receptor (ER) and progesterone receptor (PR) serves as a predictive biomarker for response to endocrine therapy, whereas HER2 expression identifies potential eligibility for anti-HER2 targeted therapy. Concurrently, the Ki-67 proliferation index provides insight into tumor proliferative activity and contributes to the assessment of biological aggressiveness.
Hormone receptor expression is evaluated based on the percentage of neoplastic cells exhibiting nuclear staining and the intensity of that staining. HER2 expression (clone 4B5) is assessed according to staining intensity and the proportion of tumor cells with membranous staining, while the Ki-67 proliferation index is calculated as the percentage of neoplastic cells with nuclear staining.
In carcinomas other than breast carcinoma, immunohistochemical assessment of HER2 oncoprotein expression (clone 4B5) is performed according to established CAP/ASCP/ASCO criteria for gastric and gastroesophageal junction adenocarcinoma.
HER2 expression is a predictive biomarker for potential administration of anti-HER2 targeted therapy.
Immunohistochemical evaluation considers the intensity, completeness, and extent of membranous staining in neoplastic cells. HER2 scoring varies according to specimen type, including biopsy material versus surgical resection specimens.
HER2 gene amplification is detected in formalin-fixed, paraffin-embedded tissue using the FDA- and CE-IVD-approved VENTANA INFORM HER2 Dual ISH DNA Probe Cocktail Assay on the fully automated VENTANA BenchMark ULTRA platform.
The assay utilizes a dual-probe method to determine the HER2/CEP17 ratio, aiding identification of patients eligible for anti-HER2 targeted therapy.
Assessment involves counting HER2 and CEP17 signals in 20 tumor cells.
The HER2/CEP17 ratio, the mean number of HER2 signals per cell, and the mean number of CEP17 signals per cell are calculated.
Immunohistochemical evaluation of PD-L1 protein expression across tumor types utilizes distinct scoring systems—primarily the Tumor Proportion Score (TPS) and the Combined Positive Score (CPS)—determined by tumor type, primary site, and therapeutic indication. Corresponding positivity thresholds vary by tumor type and treatment protocol.
PD-L1 assessment is based on membranous staining of neoplastic cells and, depending on the scoring system, may incorporate staining in specific immune-cell populations within the tumor microenvironment. PD-L1 expression serves as a predictive biomarker and, in selected tumor types, identifies patients likely to benefit from immunotherapy.
Immunohistochemical analysis of c-Met protein overexpression is conducted on formalin-fixed, paraffin-embedded tissue using the monoclonal antibody VENTANA anti-c-MET (SP44) on the fully automated VENTANA BenchMark ULTRA platform.
Per the LUMINOSITY study, c-Met overexpression in non-squamous, EGFR wild-type non-small cell lung carcinoma (NSCLC) is defined as intense membranous and/or cytoplasmic staining (3+) in ≥25% of tumor cells.
c-Met expression is further categorized as follows:
In clinical practice, high c-Met expression is a predictive biomarker of response to c-Met–targeted therapy, including the antibody–drug conjugate telisotuzumab vedotin (Teliso-V).
Immunohistochemical assessment of MTAP expression in lung carcinomas is performed using the automated VENTANA BenchMark ULTRA platform. Evaluation is based on cytoplasmic staining of neoplastic cells.
Loss of MTAP expression in lung carcinomas is an emerging biomarker with potential prognostic and predictive value, particularly for identifying candidates for novel targeted therapies.
DLL3 (Delta-like ligand 3) is commonly expressed in neuroendocrine neoplasms, especially small cell lung carcinoma (SCLC).
Immunohistochemical evaluation of DLL3 is conducted using the VENTANA DLL3 antibody (clone SP347) on the fully automated VENTANA BenchMark ULTRA platform.
Expression is quantified by the proportion of neoplastic cells exhibiting membranous and/or cytoplasmic staining.
DLL3 expression is an emerging predictive biomarker that may facilitate patient selection for DLL3-targeted therapies.
He studied medicine in Italy (University of Cagliari, Sardinia). As a doctor, he worked from 2009 to 2012 at the Naval Hospital of Crete, the General Hospital of Chania, the Health Centre of Kissamos, the rural clinic of Kolimbari, the private “Vittorakis Polyclinic” in Platanias and the “Revival” Rehabilitation Centre in Drama. He specialized in Pathological Anatomy at the “Theagenio” Cancer Hospital of Thessaloniki from 2012 to 2017. As a pathologist, he worked from 2017 to 2023 at the “Medical Inter-Balkan Hospital of Thessaloniki” and for almost one year at the private Pathology Laboratory “Istotypos”.
She received her Doctor of Medicine from School of Medicine at the University of Tashkent and completed her residency training in Pathology at the Department of Pathology and the Department of Cytology at “Theagenio” Cancer Hospital of Thessaloniki. She served for sixteen years as a Pathologist in the same Hospital. During that time, she participated with abstracts in Greek and International seminars and conferences.
She is a member of the Hellenic Society of Pathology, the European Society of Pathology and a member of Hellenic Cancer Research Society.
Persefoni Xirou studied medicine in Aristotle University of Thessaloniki, graduating with honors. She received the title of Specialist in Pathology in 1996 (Residency training: 4 years in Surgical Pathology and 1 year in Cytology). She worked as a Surgical Pathologist for almost 25 years in different public Greek hospitals (General Hospital of Volos, Agios Savvas Cancer Hospital, Papageorgiou General Hospital, Theagenion Cancer Hospital) and for 8 months in private practice. Persefoni Xirou was appointed as an international observer (from November 11 through December 6, 2019) in the subspecialty of Gastrointestinal and Thoracic in the Department of Pathology at Memorial Sloan Kettering Cancer Center under the supervision of Dr. Jinru Shia and Dr. William Travis, Program Director. She participated in a large number of national and international congresses/seminars (as attendant and with abstracts) and she has 87 presentations as invited speaker in national meetings. She is member of the Greek and European Societies of Pathology, of Greek Society of Cancer Research and of United States and Canadian Academy of Pathology (USCAP).
He studied at the Department of Medical Laboratories of the Technical University of Larissa and then passed qualifying exams and entered the Medical School of the Aristotle University of Thessaloniki.
After graduation, he was a rural doctor at the K.Y. of Farsala. Subsequently, he started and completed the specialty of Pathological Anatomy at the “Theagenio” Hospital.
He worked for 5 years at the Histopathology Department specializing exclusively in the Macroscopic Department.
To find out more or to schedule a test, contact our scientific staff at +30 2316003677
Address: E. Antistaseos 72 Eantos, 55133, Kalamaria, Thessaloniki