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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 identifycation of a predisposition to 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. Also we aresending the result to the treating physician. The model involves providing the required quality of research by building a network of certified laboratories.

Therapeutic areas

Oncology

Diagnostic services 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 presence / absence of mutations in the RAS (KRAS, NRAS) genes in patients with metastatic colorectal cancer
  • Detection of the presence / absence of mutations in the BRAF gene in patients with melanoma and metastatic colorectal cancer;
  • Immuno-histochemical analysis of rearrangements in the ALK gene;
  • Immunohistochemical assay for PD-L1 protein expression in patients with non-small cell lung cancer;
Biological materials
  • Formalin-fixed and paraffin-embedded tumor tissue
  • Venous blood (liquid biopsy)
  • Urine (liquid biopsy)
Infectious disease

The company has developed processes for the diagnosis and follow-up of infectious disease (ex. therapies for treating viral hepatitis C according to the genotype of the virus).

Processes

The work process managed by ProDoct in the field of companion diagnostics includes full provision of the necessary 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 necessary 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 validation of molecular tests, first of all by collecting samples fromdifferent patient populations (e.g. for diagnosis of tuberculosis). Distances are irrelevant, and we have sent samples to several continents.

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Clinical trials

The company operates as a Contract Research Organization (CRO) for both medicAL products and devices.

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