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Nikolaos Tsoulos, MBA, PhD, Molecular Biochemist, CEO of GeneKor Medical SA, and Chairman of the Hellenic Society of Diagnostic Laboratories (EDEM), spoke to Iatronet about accredited diagnostic laboratories capable of conducting specialized molecular tests aimed at detecting biomarkers. He emphasized that most modern therapeutic regimens for treating malignancies are related to identifying specific biomarkers.
At the same time, he highlighted the necessity of creating an appropriate budget that would ensure a healthy environment for performing these specialized analyses, free from clawback measures.
Certified laboratories are those accredited by the Hellenic Accreditation System (ESYD) and have acquired ISO 15189 certification. This accreditation ensures the proper operation of the laboratory, both in terms of infrastructure (suitable and modern equipment), handling biological samples, and scientific excellence. This is achieved through the laboratory’s participation in annual international external quality assessments and the comprehensive scientific training of its staff.
Consequently, samples from international organizations with unknown outcomes are processed, analyzed, and evaluated based on their accuracy, result structure, analysis completion time, and result interpretation. These accreditations are deemed essential and highly significant in modern laboratory practice, as they ensure the quality of results for certified analyses and the overall proper functioning of a laboratory. Thus, the National Health System guarantees the provision of quality medical analyses to patients across the country.
The number of accredited laboratories, depending on the analyses and tests they have accredited, is significant and can be found in detail on the ESYD website. However, when it comes to biomarkers specifically, the number of accredited laboratories is significantly limited. This is because the proper analysis and interpretation of biomarkers must only be performed by specialized molecular biology laboratories.
The vast majority of cancer patients need the information provided by biomarkers. Most modern therapeutic regimens for treating malignancies are related to identifying specific biomarkers. As a result, tests conducted annually involve dozens of biomarkers and thousands of patients. Notable examples include biomarkers associated with targeted molecular therapies for Non-Small Cell Lung Cancer, Breast Cancer, Colorectal Cancer, and others.
GeneKor is one of the first molecular biology laboratories specializing in oncology in Greece and one of the largest molecular oncology laboratories in Europe. The company was founded in 2007 in Athens and now has subsidiaries in six countries (Turkey, Romania, Latvia, Estonia, Czech Republic, Slovakia), employing over 100 people in Greece alone.
In our laboratories, specialized molecular tests are conducted to detect biomarkers that help patients and physicians manage diseases. These tests are accredited, as our priority is the quality and swift provision of services to all patients.
The inclusion of more biomarkers is a particularly optimistic development, and the accredited laboratories in our country are sufficient and capable of meeting these new demands. However, the greatest challenge lies in creating an appropriate budget that ensures a healthy environment for performing these specialized analyses. Biomarker testing involves high execution costs (primarily due to the high cost of reagents), while at the same time, it is indicated for specific patients and clinical cases.
As a result, there is no induced demand, and consequently, no reason to apply clawback measures. Lastly, it should be noted that biomarkers must be analyzed while adhering to the highest quality standards, as they determine the personalized therapeutic regimen of the patients being tested.