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Companion diagnostic

Personalized therapy is a new medical approach that changes the maxim “one size fits all” to “the right treatment, the right patient, at the right time”. This approach is based on innovations in areas such as functional genomic technologies, molecular diagnostics, data analysis, and real-time monitoring of conditions for better patient health care, identifying therapies to achieve the best results in disease management, or the identification of a predisposition to an illness.

Providing companion diagnostics for the needs of personalized medicine is one of the core activities of ProDuCt.

We offer the development of a logistical and diagnostic model for molecular research oriented to a particular target therapy. The service includes the collection and logistics of the biological material, providing the appropriate methodology, equipment and laboratory for the test, ensuring that CE IVD certified reagents are used and that they are compatible with the process. Moreover, we are sending the result to the treating physician. The model involves providing the required quality of research by building a network of certified laboratories.

Therapeutic areas

Diagnostic service packages have been developed for:

  • Non-small cell lung cancer
  • Metastatic colorectal cancer
  • Breast cancer
  • Ovarian cancer
  • Melanoma
Biomarkers
  • Mutation analysis of the EGFR gene in patients with non-small cell lung cancer
  • Detection of the presence or absence of mutations in the RAS (KRAS, NRAS) genes in patients with metastatic colorectal cancer
  • Detection of the presence or absence of mutations in the BRAF gene in patients with melanoma and metastatic colorectal cancer;
  • Immunohistochemical analysis of rearrangements in the ALK gene;
  • Immunohistochemical assay for PD-L1 protein expression in patients with non-small cell lung cancer and urothelial carcinoma;
Biological materials
  • Formalin-fixed and paraffin-embedded tumor tissue
  • Venous blood (liquid biopsy)
  • Urine (liquid biopsy)

Processes

The work process managed by ProDuCt in the field of companion diagnostics includes full provision of the necessities for the development of a sustainable but also flexible patient program. This includes, but is not limited to:

  • Selection of laboratories
  • Selection of qualified specialists
  • Providing the necessary CE-IVD reagents for the analysis
  • Preparation of all project documents
  • Logistics of the patient’s materials

Contractors

Physicians and lab assistants from pathoanatomic laboratories 21
Nurses 20
Genetic laboratories 7
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Validation studies

We at ProDuCt aim not only to provide the necessities for the implementation of the companion diagnostics but also to actively support the development of new, more sensitive and specific tests. We are involved in the validation of molecular tests, first of all by collecting samples from different patient populations (e.g. for the diagnosis of tuberculosis). Distances are irrelevant and we have sent samples to several continents.

Topics in scope:
  • Validation of non-invasive molecular diagnostic tests, based on “liquid biopsy” in the area of oncology
  • Validation of a rapid diagnostic test for the diagnostics of tuberculosis infections
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Clinical trials

The company operates as a Contract Research Organization (CRO) for the conduction of clinical trials for both medical products and medical devices. ProDuCt is being established more and more as a reliable partner of interested companies in the accomplishment of clinical trials, offering a full and complete process from the creation of the study protocol, obtaining the standpoint of the ethics committee, the passage of the monitoring visits and the completion of the study.

Our competencies include:
  • Study design;
  • Analysis and reporting of pre-clinical data;
  • Protocol development;
  • Case report form (CRF) design;
  • Development of investigator brochures and integrated summaries;
  • Site identification, pre-study feasibility;
  • Overall project management, identification of potential problems;
  • Site monitoring and management, liaisons to the sites; site regulatory documents collection;
  • Regulatory submission;
  • Safety data review and reconciliation of adverse events and serious adverse events;
  • Data management and statistical analysis of study data;
  • Organization of trainings;
  • Report writing etc.
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