Quality control materials for control of molecular diagnostic tests for oncology/genetic testing.

Offentlig prosjektsammendrag

Increasing number of molecular diagnostic tests is available on the market, and the recent advances in molecular testing technologies has led to an increased role of molecular diagnostics in patient care. However, the state of the art of quality control (QC) for molecular diagnostic tests has lagged behind, in comparison with other laboratory diagnostic tests. Due to the increased complexity and throughput of molecular tests, the lack of available independent (third party) QC materials may prevent laboratories from an early detection of a test failure, which will negatively impact the reliability of diagnostic tests, and can potentially have serious consequences for the patient health. A prospect of stringent oversight and regulation of molecular diagnostics will lead to the increased need for independent QC materials. A demand for independent QC materials for the purpose of accreditation of test methods in diagnostic laboratories is also expected to rise with an increasing number of available molecular diagnostic tests. Additionally, diagnostic laboratories in Scandinavia are becoming more and more quality-conscious, and the demand for QC materials in the region will increase. SERO's goal is to develop novel class of independent QC materials for molecular diagnostic tests in oncology and genetic testing. The result of this project, namely the improved availability on the market of independent QC materials for molecular testing, will provide reliable and relevant tools to address quality assurance issues in molecular diagnostic laboratories. The increased use of independent QC materials in Norway and abroad alike, will contribute to more reliable diagnosis, improving the quality of the patient care.