Genetic Analysis said this week that its GA-map IBS Dysbiosis test is now CE marked and available for use on clinical samples in European labs. The company also announced that it has signed a license and supply agreement with Applied BioCode for its barcoded magnetic bead technology for multiplex array analysis.
Thomas Borge, Genetic Analysis' sales and marketing director, told BioArray News in an email this week that the Oslo-based firm has already optimized its GA-map IBS assay for use on BioCode's instrument and, with a newly won CE mark, this version of the test is now clinically available in Europe.
The GA-map assay, which targets dysbiosis — an imbalance of gut microbacteria that can lead to the development of irritable bowel disease and other gastrointestinal aliments — was developed at the University of Oslo and consists of probes and primer sets for between 30 and 200 different bacterial species present in the gastrointestinal tract, now detected on BioCode's microarray platform.
Based on the test results, clinicians can distinguish patients with IBS or IBD from those with other gastrointestinal disorders.
According to Borge, the decision to adopt BioCode's technology was based on the fact that the instrument's 96-well format was a good fit for the number of targets in the GA-map IBS test. Additionally, he wrote, the platform met the company's "reproducibility, robustness, ease of use, and high sensitivity" requirements.
Genetic Analysis initially developed the test using its own GA-map array platform, Borge explained, "but for th[is] initial commercialization, Applied Biocode stood out as a good partner with its BioCode reader system." The company has been working with the system for about a year, he added.
Genetic Analysis CEO Kari Stenersen told BioArray News last year that the company also hopes to have the GA-map IBS test approved for clinical use in the US by the end of 2015.
Borge said this week that the company is currently seeking US laboratories interested in performing the test for research use only, and plans to submit an application to the FDA in early 2015.