Test kit “Cystic Fibrosis-BioChip”, aimed for detection of 25 mutations in CFTR gene that are found at high frequency in Slavic population and are associated with Cystic Fibrosis development, got an CE-mark in January 2013.

The analysis is made on microarrays. Target DNA-strings, congruent with wild type and mutant alleles are applied to the base by the robotized print system. The fluorescent-labeled probes are synthesized by means of DNA amplification whereupon hybridization is run (fluorescence of appropriate spots take place). Microarray scanner is needed to obtain the results. In conclusion of the procedure specialized software issue a summary of the results (if the patient has mutations in CFTR gene, which ones).

CE-mark confirm that «Cystic Fibrosis-BioChip» diagnostic kit satisfy the safety requirements stated in EU directives and indicate the highest quality of the product.